Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Sr. Director of Global Marketing Strategy & Operations is responsible for collaborating with a matrix team to streamline and optimize marketing operations and drive effectiveness within Daiichi-Sankyo and its Partners at a Global level and between Global and Regions. The individual will focus on leveraging both companies' capabilities to support the Global Brand Team activities. The individual will be responsible for developing innovative solutions to simplify marketing operations and deliverables of the Global Brand Team, identifying inefficiencies, and proposing solutions to streamline activities. The individual will also lead the above indication strategy for the Brand including over- arching brand positioning and execution and will manage and oversight the agency of record. This position will report directly to the Head of Global Oncology Marketing. Responsibilities: Brand Strategic plan coordination with budget, forecast consolidation and new opportunity assessment: Coordinate and facilitate the brand planning process across the different oncology indications (Breast and non-breast indications) including coordination of brand team meetings, guidance to brand leads, budget consolidation and investment tracking and dissemination to the regions. Among key deliverables, there is a full accountability of getting key sessions with regions and or workshop around BSP to meet Brand leads expectation. Coordinate short- and long-term forecast updates by consolidating sales and volume forecasts across indications and across regions. Be the point of contact with the Supply team to ensure capacity will meet forecasted demand. Support Brand lead in financial assessment of different business opportunities required for R&D investment decision for the Life Cycle Management of asset. Interface with regions: Streamline interactions with regions ; develop and execute a launch readiness framework; develop tools and activities to help dissemination of information from Global to Regions and capture of knowledge and learning from regions to feedback in the global team and cross fertilize between market to enable brand performance In collaboration with Brand leads, develop the forecasting guidance and disseminate to regions In collaboration with the Brand leads and market access leads, define the optimal launch sequencing (geography x tumors types) through the ROW taskforce Develop and maintain tools where information is easy to access and up to date Lead cross-fertilization initiative between regions and between different brand teams at the global level Process optimization and alliance facilitators: With support of alliance project managers, propose and lead initiatives to drive further efficiencies within the alliance. Initiatives include, but are not limited to, improvements on brand plan process, launch readiness excellence, execution of operation within the alliance governance to ensure that the alliance is operating smoothly and efficiently Being the Agency of Record lead to optimize interface with Brand lead and budget allocation Support Brand leads in the coordination of the JMAMT Above indication Brand strategy: Develop and execute an Above- indication brand strategy including Brand positioning, Cross indication initiative Oversee and consolidate Brand presence at major congresses (ASCO / ESMO) Work closely with PR to provide insight to PR plan to generate a pan tumor asset PR communication Make strategic analysis and recommendation on any topic that are non-tumor specific (i.e., New formulation) Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Required: Bachelor's degree with emphasis in health science Preferred: MBA or other advanced degree Required: Minimum of 10+ years of marketing experience in the Oncology space Preferred: Experiences in the global markets and successful launches International business experience (worked in multiple regions and/or worked as global team member) Experience launching a brand as leading position (as Global Brand Lead preferred) Ability to travel up to 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Global Marketing Strategy & Operations- Oncology ADC City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
01/27/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Sr. Director of Global Marketing Strategy & Operations is responsible for collaborating with a matrix team to streamline and optimize marketing operations and drive effectiveness within Daiichi-Sankyo and its Partners at a Global level and between Global and Regions. The individual will focus on leveraging both companies' capabilities to support the Global Brand Team activities. The individual will be responsible for developing innovative solutions to simplify marketing operations and deliverables of the Global Brand Team, identifying inefficiencies, and proposing solutions to streamline activities. The individual will also lead the above indication strategy for the Brand including over- arching brand positioning and execution and will manage and oversight the agency of record. This position will report directly to the Head of Global Oncology Marketing. Responsibilities: Brand Strategic plan coordination with budget, forecast consolidation and new opportunity assessment: Coordinate and facilitate the brand planning process across the different oncology indications (Breast and non-breast indications) including coordination of brand team meetings, guidance to brand leads, budget consolidation and investment tracking and dissemination to the regions. Among key deliverables, there is a full accountability of getting key sessions with regions and or workshop around BSP to meet Brand leads expectation. Coordinate short- and long-term forecast updates by consolidating sales and volume forecasts across indications and across regions. Be the point of contact with the Supply team to ensure capacity will meet forecasted demand. Support Brand lead in financial assessment of different business opportunities required for R&D investment decision for the Life Cycle Management of asset. Interface with regions: Streamline interactions with regions ; develop and execute a launch readiness framework; develop tools and activities to help dissemination of information from Global to Regions and capture of knowledge and learning from regions to feedback in the global team and cross fertilize between market to enable brand performance In collaboration with Brand leads, develop the forecasting guidance and disseminate to regions In collaboration with the Brand leads and market access leads, define the optimal launch sequencing (geography x tumors types) through the ROW taskforce Develop and maintain tools where information is easy to access and up to date Lead cross-fertilization initiative between regions and between different brand teams at the global level Process optimization and alliance facilitators: With support of alliance project managers, propose and lead initiatives to drive further efficiencies within the alliance. Initiatives include, but are not limited to, improvements on brand plan process, launch readiness excellence, execution of operation within the alliance governance to ensure that the alliance is operating smoothly and efficiently Being the Agency of Record lead to optimize interface with Brand lead and budget allocation Support Brand leads in the coordination of the JMAMT Above indication Brand strategy: Develop and execute an Above- indication brand strategy including Brand positioning, Cross indication initiative Oversee and consolidate Brand presence at major congresses (ASCO / ESMO) Work closely with PR to provide insight to PR plan to generate a pan tumor asset PR communication Make strategic analysis and recommendation on any topic that are non-tumor specific (i.e., New formulation) Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Required: Bachelor's degree with emphasis in health science Preferred: MBA or other advanced degree Required: Minimum of 10+ years of marketing experience in the Oncology space Preferred: Experiences in the global markets and successful launches International business experience (worked in multiple regions and/or worked as global team member) Experience launching a brand as leading position (as Global Brand Lead preferred) Ability to travel up to 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Global Marketing Strategy & Operations- Oncology ADC City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Global Brand Lead- Oncology Breast City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
01/27/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Global Brand Lead- Oncology Breast City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Global Brand Lead- Oncology Non Breast City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
01/27/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Global Brand Lead- Oncology Non Breast City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Global Brand Lead- Oncology ADC City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
01/27/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Executive Director, Global Brand Lead is accountable to lead the brand strategy at global level, lead the Global Brand Team (GBT) where all cross-functions get alignment on the brand strategy by developing their respective functional tactical plans meeting the strategic imperatives of the brand. Within the Brand strategy, the brand lead is accountable to develop pre-launch and commercialization strategy to be handed over to regions and serve as " chief orchestra" for the brand around the world by securing alignment with regions and consistency of what regions do for brand commercialization. As core member of the GPT (Global Project team), the Brand Lead is accountable to provide commercial insights to the R&D team to ensure that development activities will meet customer expectations once the product becomes a Brand at regulatory approval. This position influences Market Insight and Analytics by making sure that all projects are relevant to inform the Brand strategy as well as owning the accountability of the forecasting assumptions in the forecasting exercise. Finally, the Executive Director, Global Brand Leader must be recognized as the Subject Matter Expert of the Brand in its current and future indications in respective tumor types and environment. Responsibilities: Brand Strategy: Develop and own the Brand Strategy (Brand Plan) and marketing functional tactical plan. Within the Global Brand Team (GBT), the Brand Lead is accountable to secure alignment with other functions at global level and make sure that respective functional tactical plans are relevant to the defined Brand strategy and to secure alignment with regional commercialization team with the global strategic guidance. While the Executive Director, Global Brand Lead owns directly the execution of the global marketing tactical plan in a timely manner and within the agreed investment, he/she has to secure proper execution of other functional tactical plans within the GBT. The global Brand Lead is expected to play a central role as the leader of the Global Brand Team across all functions and lead all the global functions as one team. In his role of leader of the GPT, the Brand Lead should be able to manage quick turn around when an external or internal event happens and require a strategic adjustment (i.e., Brand issue in a given market, new competitive events) For Brand in alliance with a partner, the Executive Director, Global Brand Leader will partner with his/her counterpart to secure alignment between the two companies and between all commercialization functions and will serve as key representative of the Marketing function in the joint committees as needed (e.g., Co-lead of the joint GPT , active member in the JLT, ad hoc presenter in JCC, JEC) As the final sign-on of all activities above is made by the Head of Global Oncology Marketing, the Executive Director, Global Brand Leader will have to establish and keep an effective communication with him/her Commercialization Strategy: From the Brand Strategy, accountable to develop a fully loaded pre-launch and commercialization launch strategy at global level which include positioning, communication platform with core message & story flow, branding elements, campaign and campaign evolution, disease awareness. Accountable though the GBT that all commercialization efforts, mainly medical affairs, HEOR and Pricing Access are aligned with the prelaunch and launch strategy. Will work closely with the first market to launch to make sure that promotional materials are aligned with the global commercialization strategy and facilitate best practice sharing across the regions. The commercialization strategy includes an overseeing of the ROW approval/commercial launches. Based on close relationship with his/her peer in regions , will monitor the performance of the brand in major markets (G8, US, EU5, JP, China) by defining the key KPI of the brand, identified challenges (headwinds) and proposed resolution in a timely manner. Commercial Input In R&D Strategy: As key member of the GPT, the Brand lead is accountable to provide commercial insights to the R&D team to make sure that the development strategy matches the customer needs to secure success of the company in the future commercialization. This includes, but not limited to, insight on market sizing, patient flow, current Standard of Care, market evolution, current and future competitive landscape, value dynamic and other relative elements on the market evolution Acts as key stakeholder in the development of the Target Profile (Customer Expectation) and Expected Product Profile. To do so, the Executive Director, Global Brand Leader interacts with all regional stakeholders to make sure that the insight provided to R&D is meeting regional needs. Ultimately, Executive Director, Global Brand Leader needs to exercise a voice on the clinical study design (Choice of the comparator, selection of endpoint, statistical assumptions, etc.) as well as into the regulatory document (CDDS, UPSI, CHMP) Accountable to get all financial assessments completed in timely manner which may also require customer insights to validate forecasting assumption as well as the Commercial Statement of Interest for all projects presented to R&D committees such as CESP, GEMARD Cross Functional and Team Leadership: Act as leader of the GBT by coordinating cross-functional and regional inputs into the brand strategy and R&D feedback and by making sure that all the functional tactical plans are in line with the strategy Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in health science, required MBA or other advanced degree, preferred 10 or more years of experience in: Field of Oncology, global markets, and successful launches, preferred Marketing, required Oncology experience, required International business experience preferred Launching a brand as leading position preferred Ability to travel up to 20%; Perform/attend meetings outside of normal working hours: 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Global Brand Lead- Oncology ADC City Basking Ridge Functional Area Global Oncology Marketing State New Jersey
Join a Legacy of Innovation 110 Years and Counting! With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Job Summary: Medical Affairs leader for assigned compound under the supervision and leadership of the Global Medical Affairs (GMA) Franchise Head. Develops the GMA strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management. May have direct reports. Responsibilities: Responsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective. Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. Represents medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions. Lead the team with sleeves rolled up, model the way and enable the team to act. Provides medical leadership to GMA clinical operations teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a Global IIS Review Committee, for assigned compound. Collaborates across GMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data. Provides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations. Works with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively. Provides input into publication strategy, data gap analysis, and tactical planning as part of the overall GMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents. Manage budgets and resources efficiently for GMA supported activities within the GMA plan, in collaboration with GMA Franchise Head. Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Required Experience and Skills Doctorate required, PhD, PharmD, or MD Must have oncology experience, specifically in solid tumors 10+ years pharma, minimum of 5 years of (in-house) medical affairs experience, global preferred Previous overall responsibility and accountability for multiple indications of one or more compounds and related GMA plan/budget for related MA activities Demonstrated ability to lead and influence others internally and externally Experience leading matrix medical teams (e.g. GMAT) and representing medical on cross-functional leadership teams (e.g. Global Product Team, Global Brand Team, etc.) Relationships with key opinion leaders Proven ability to manage multiple priorities at one time Preference Skills Knowledge of ADC or other biologics, or small molecules Demonstrated experience working with an alliance partner company Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, GMA Oncology City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey
01/26/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Job Summary: Medical Affairs leader for assigned compound under the supervision and leadership of the Global Medical Affairs (GMA) Franchise Head. Develops the GMA strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management. May have direct reports. Responsibilities: Responsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective. Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. Represents medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions. Lead the team with sleeves rolled up, model the way and enable the team to act. Provides medical leadership to GMA clinical operations teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a Global IIS Review Committee, for assigned compound. Collaborates across GMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data. Provides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations. Works with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively. Provides input into publication strategy, data gap analysis, and tactical planning as part of the overall GMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents. Manage budgets and resources efficiently for GMA supported activities within the GMA plan, in collaboration with GMA Franchise Head. Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Required Experience and Skills Doctorate required, PhD, PharmD, or MD Must have oncology experience, specifically in solid tumors 10+ years pharma, minimum of 5 years of (in-house) medical affairs experience, global preferred Previous overall responsibility and accountability for multiple indications of one or more compounds and related GMA plan/budget for related MA activities Demonstrated ability to lead and influence others internally and externally Experience leading matrix medical teams (e.g. GMAT) and representing medical on cross-functional leadership teams (e.g. Global Product Team, Global Brand Team, etc.) Relationships with key opinion leaders Proven ability to manage multiple priorities at one time Preference Skills Knowledge of ADC or other biologics, or small molecules Demonstrated experience working with an alliance partner company Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, GMA Oncology City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The purpose of the Sr. Director, Chief of Staff - Global Oncology R&D is to play a central role in orchestrating and delivering support to the Global Head of Oncology R&D by driving strategy as well as managing and facilitating key oncology R&D programs and initiatives to make Daiichi Sankyo a leading global pharma innovator with a competitive edge in oncology. The Chief of Staff will have direct accountability for administrative deliverables; will interact regularly with senior leadership in a delegate capacity; and will play a role to interface with the Oncology Business Unit (OBU) leadership team to integrate Cancer Enterprise (CE) globally. In addition, the Chief of Staff will support the Global Head of Oncology R&D in his/her R&D role as well as other roles such as Chair of Cancer Enterprise and co-Chair of GEMRAD (Global R&D Governance Committee). This role will also interact with the Global Head of OBU and key DS stakeholders in Japan. Responsibilities: Build a thorough understanding of all core business functions of the organization, the development portfolio, and apply that knowledge to effectively manage strategic and tactical initiatives globally; Support the Head of Oncology R&D through programs and initiatives that will shape and drive Cancer Enterprise strategy and delivery including franchise strategy, operating model and external relations with key stakeholders Proactive identification of issues that could impact the successful execution of business objectives; Elevate issues and opportunities about which the Global Head of Oncology R&D should be aware and frame/position ideas to resolve the problem/mitigate the risk/benefit from the opportunity; Accountability for day-to-day business operations as decided by Head of Oncology R&D Work with Cancer Enterprise office and stakeholders to ensure seamless operation and exemplary decision-making performance of Daiichi Sankyo governance bodies as relevant to Cancer Enterprise (e.g., CESP, GEMRAD). Ensure preparation for meetings and coordination and facilitation across bodies Deliver routine, concise updates on project statuses and next steps to thoroughly prepare Global Head of Oncology R&D for upcoming discussions, commitments, and meetings; Act as representative for DS Head of Oncology R&D in appropriate meetings to gather information, provide input and facilitate efficient decision making Coordinate Cancer Enterprise leadership and stakeholders globally (e.g., in Japan) to ensure effective communication, effective decision making and consensus building where required in Japan) to ensure effective communication, effective decision making and consensus building where required Manage CEO/President's affairs and communications with business partners and management team on critical initiatives so they receive needed responses, guidance, and decisions; Prepare presentation documents, speaker notes and memos for meetings, conferences and other venues Prepare communications on behalf of Head of Oncology R&D for stakeholders of all levels both internally (e.g., Cancer Enterprise monthly newsletter) and externally (e.g., investors/analysts meetings, KEE, internal global partners) In conjunction with finance and Project Management support Head of Oncology R&D in management of budget, capacity, resources and preparation of associated reports Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree/Advanced Degree required 10+ years of prior experience in project management, preferably within the biotech/pharmaceutical industry and consulting within a prominent management consulting firm) Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Chief of Staff Global Oncology R & D City Basking Ridge Functional Area Global Oncology R&D State New Jersey
01/25/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The purpose of the Sr. Director, Chief of Staff - Global Oncology R&D is to play a central role in orchestrating and delivering support to the Global Head of Oncology R&D by driving strategy as well as managing and facilitating key oncology R&D programs and initiatives to make Daiichi Sankyo a leading global pharma innovator with a competitive edge in oncology. The Chief of Staff will have direct accountability for administrative deliverables; will interact regularly with senior leadership in a delegate capacity; and will play a role to interface with the Oncology Business Unit (OBU) leadership team to integrate Cancer Enterprise (CE) globally. In addition, the Chief of Staff will support the Global Head of Oncology R&D in his/her R&D role as well as other roles such as Chair of Cancer Enterprise and co-Chair of GEMRAD (Global R&D Governance Committee). This role will also interact with the Global Head of OBU and key DS stakeholders in Japan. Responsibilities: Build a thorough understanding of all core business functions of the organization, the development portfolio, and apply that knowledge to effectively manage strategic and tactical initiatives globally; Support the Head of Oncology R&D through programs and initiatives that will shape and drive Cancer Enterprise strategy and delivery including franchise strategy, operating model and external relations with key stakeholders Proactive identification of issues that could impact the successful execution of business objectives; Elevate issues and opportunities about which the Global Head of Oncology R&D should be aware and frame/position ideas to resolve the problem/mitigate the risk/benefit from the opportunity; Accountability for day-to-day business operations as decided by Head of Oncology R&D Work with Cancer Enterprise office and stakeholders to ensure seamless operation and exemplary decision-making performance of Daiichi Sankyo governance bodies as relevant to Cancer Enterprise (e.g., CESP, GEMRAD). Ensure preparation for meetings and coordination and facilitation across bodies Deliver routine, concise updates on project statuses and next steps to thoroughly prepare Global Head of Oncology R&D for upcoming discussions, commitments, and meetings; Act as representative for DS Head of Oncology R&D in appropriate meetings to gather information, provide input and facilitate efficient decision making Coordinate Cancer Enterprise leadership and stakeholders globally (e.g., in Japan) to ensure effective communication, effective decision making and consensus building where required in Japan) to ensure effective communication, effective decision making and consensus building where required Manage CEO/President's affairs and communications with business partners and management team on critical initiatives so they receive needed responses, guidance, and decisions; Prepare presentation documents, speaker notes and memos for meetings, conferences and other venues Prepare communications on behalf of Head of Oncology R&D for stakeholders of all levels both internally (e.g., Cancer Enterprise monthly newsletter) and externally (e.g., investors/analysts meetings, KEE, internal global partners) In conjunction with finance and Project Management support Head of Oncology R&D in management of budget, capacity, resources and preparation of associated reports Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree/Advanced Degree required 10+ years of prior experience in project management, preferably within the biotech/pharmaceutical industry and consulting within a prominent management consulting firm) Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Chief of Staff Global Oncology R & D City Basking Ridge Functional Area Global Oncology R&D State New Jersey
Join a Legacy of Innovation 110 Years & Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary : Lead execution and project management of Global Medical Affairs clinical activities, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The types of clinical activities supported include Collaborative external sponsored studies (CESR)and Investigator Initiated Studies (IIS). A key focus will be the oversight of, and interactions with research sites, regional Medical team and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team. The Assoc. Director will be expected to work in a collaborative, global environment and establish good communication with colleagues in other functions and across regional locations. The Assoc. Director will take responsibility for the clinical operational strategy and overall delivery of the Collaborative study or IIS (i.e. Delivery Lead role) and will represent Clinical Operations on the study team. This position may require future line management responsibility of Clinical Study Managers, who are primarily responsible for the tactical execution of the study. In the absence of Clinical Study Managers, the Associate Director will be expected to take both strategic and tactical roles in order to deliver the study. At this level, the incumbent may be expected to lead a program of studies. Responsibilities: Study Planning, Budget and Execution Work closely with Outsourcing and Legal on RFP, Scope of Work documents, contracts and any other documents necessary to ensure vendors are properly selected and contracted with, in accordance with DS policies and procedures. Oversee contracts once approved with regards to adherence to timelines, budgets and scope of work. Lead the study team to develop a cross-functional, integrated study implementation plan including creation of initial study budget. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall plan agreed by the Project Team. Lead site selection and site qualification discussions with study team and vendors as required. Across all programs, responsible for: oversight of protocol /protocol amendment development, review and approval process incorporating the proper operational delivery aspects and logistics into the protocol development or input into other study related documents including but not limited to ICF, CRF guidelines, project management plans, monitoring plans etc input into other relevant documents related to safety, regulatory, data management, clinical supplies etc. Lead the study team kick-off meetings and subsequent team meetings (DS alone or with vendors). Take responsibility to ensure meeting logistics, agenda and minutes are in accordance with DS standards. Oversee the CESR program and other vendors timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans. Maintain quality and oversight of all study deliverables from start up to delivery of CSR through close collaboration across functions, stakeholders and vendors. As required, the Associate Director provides operational input into regional Medical Affairs studies. Study and vendor and Quality Oversight Responsible for management of the study site relations and any vendor performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to senior management or the appropriate governance committee. Create the budget at study start up and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately. Provide oversight of the CESR to ensure compliance with Daiichi Sankyo's quality measures. Lead the creation of the Quality Oversight Plan (QOP) and ensure study team adherence to the QOP. Be aware of and be able to predict deviations, or potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to senior management or the appropriate Governance Committee. Clinical Operations Management/General Participate in the development of procedures and SOP's related to Global Medical Affairs clinical operations activities, in collaboration with Operational Excellence team. Collaborate with Quality Assurance, QC function and regulatory Operations to implement quality standards across all activities, systems and processes. Support the implementation of CAPA in relation to sponsor's audit or regulatory inspection. Provide input into quarterly budget management activities. Participate in GMA driven initiatives Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: A Bachelor's degree in the Life Sciences is required. Master's degree (Life Sciences) is preferred. Assoc. Director level: 7 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO). Manager level: 4 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO). Experience in Medical Affairs and oncology desired; EAP experience highly desired and preferred. CRA and/or Study Site Coordinator experience is also considered relevant. PMP certificate a plus. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Manager/Assoc. Director, Clinical Trial Mgt & Resources, GMA Oncology City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey
01/20/2021
Full time
Join a Legacy of Innovation 110 Years & Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary : Lead execution and project management of Global Medical Affairs clinical activities, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The types of clinical activities supported include Collaborative external sponsored studies (CESR)and Investigator Initiated Studies (IIS). A key focus will be the oversight of, and interactions with research sites, regional Medical team and other external vendors to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team. The Assoc. Director will be expected to work in a collaborative, global environment and establish good communication with colleagues in other functions and across regional locations. The Assoc. Director will take responsibility for the clinical operational strategy and overall delivery of the Collaborative study or IIS (i.e. Delivery Lead role) and will represent Clinical Operations on the study team. This position may require future line management responsibility of Clinical Study Managers, who are primarily responsible for the tactical execution of the study. In the absence of Clinical Study Managers, the Associate Director will be expected to take both strategic and tactical roles in order to deliver the study. At this level, the incumbent may be expected to lead a program of studies. Responsibilities: Study Planning, Budget and Execution Work closely with Outsourcing and Legal on RFP, Scope of Work documents, contracts and any other documents necessary to ensure vendors are properly selected and contracted with, in accordance with DS policies and procedures. Oversee contracts once approved with regards to adherence to timelines, budgets and scope of work. Lead the study team to develop a cross-functional, integrated study implementation plan including creation of initial study budget. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall plan agreed by the Project Team. Lead site selection and site qualification discussions with study team and vendors as required. Across all programs, responsible for: oversight of protocol /protocol amendment development, review and approval process incorporating the proper operational delivery aspects and logistics into the protocol development or input into other study related documents including but not limited to ICF, CRF guidelines, project management plans, monitoring plans etc input into other relevant documents related to safety, regulatory, data management, clinical supplies etc. Lead the study team kick-off meetings and subsequent team meetings (DS alone or with vendors). Take responsibility to ensure meeting logistics, agenda and minutes are in accordance with DS standards. Oversee the CESR program and other vendors timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans. Maintain quality and oversight of all study deliverables from start up to delivery of CSR through close collaboration across functions, stakeholders and vendors. As required, the Associate Director provides operational input into regional Medical Affairs studies. Study and vendor and Quality Oversight Responsible for management of the study site relations and any vendor performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to senior management or the appropriate governance committee. Create the budget at study start up and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately. Provide oversight of the CESR to ensure compliance with Daiichi Sankyo's quality measures. Lead the creation of the Quality Oversight Plan (QOP) and ensure study team adherence to the QOP. Be aware of and be able to predict deviations, or potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to senior management or the appropriate Governance Committee. Clinical Operations Management/General Participate in the development of procedures and SOP's related to Global Medical Affairs clinical operations activities, in collaboration with Operational Excellence team. Collaborate with Quality Assurance, QC function and regulatory Operations to implement quality standards across all activities, systems and processes. Support the implementation of CAPA in relation to sponsor's audit or regulatory inspection. Provide input into quarterly budget management activities. Participate in GMA driven initiatives Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: A Bachelor's degree in the Life Sciences is required. Master's degree (Life Sciences) is preferred. Assoc. Director level: 7 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO). Manager level: 4 years clinical operations experience in a Pharmaceutical company, or Contract Research Organization (CRO). Experience in Medical Affairs and oncology desired; EAP experience highly desired and preferred. CRA and/or Study Site Coordinator experience is also considered relevant. PMP certificate a plus. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Manager/Assoc. Director, Clinical Trial Mgt & Resources, GMA Oncology City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Responsible for working directly with business partners, business analysts, and other developers in creating scalable solutions which effectively and efficiently satisfy the business decision making needs. Responsible for the design, development, maintenance and distribution of our internal analytics applications to provide reliable data faster to support decision making. The Data and Advanced Analytics Analyst will be assigned to multiple projects which will be spread across several departments in all three divisions of DSI - Daiichi Sankyo Pharma Development (DSPD) Division, the U.S. Commercial Division (USCD) and the Daiichi Sankyo U.S. Business (DSUSB). Look at problems in unique ways, help teams to use data to improve decision making, build innovative custom solutions, and act as a liaison between IT and end users. The position requires a solid understanding of the drivers of the business and the ability to translate these into meaningful analytical tools to support their analytical needs. Responsibilities: Design and develop data and advanced analytics environments that support DSI's functional reporting solutions. Build business intelligence, machine learning and artificial intelligence Design business intelligence capabilities and best practices that are complete and actionable, including performing information analysis in support of designing solutions. Make design recommendations of how to visualize key metrics and performance indicators like ROI, valuation, opportunity, turnover and access. Contribute to the development, testing, and integration of reporting and analysis solutions. Successfully rollout newly developed capabilities from start to finish. Support end-users through informal hands-on usage training and educate users on best practices and business intelligence solutions. Collaborate with business stakeholders to understand their needs for data and advanced analytics environments. Partner with IT stakeholders and vendors for the support of business objectives. Provide ongoing support services and expert knowledge regarding data integration, business intelligence, machine learning and artificial intelligence solutions and platforms. Responsible for the integrity and quality of data and information stored and flowing between business applications, data warehouse, integration hubs and business intelligence applications. Administer and maintain the technology platforms including but not limited to Informatica Cloud, Azure Data Factory and PowerBI Demonstrates high level proficiency for emerging Business Intelligence, Machine Learning and Artificial Intelligence technology, aligning with toolset future roadmaps, keeps informed of latest trends and developments in technologies. Perform additional duties and projects as required by the manager. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in Information Systems, Computer Science or business related discipline. Advanced degrees are a plus but not required. 5 years of hands-on experience in application development, Business intelligence, Data integration, Machine Learning, Artificial Intelligence and advanced analytics with emphasis on Microsoft Azure suite (examples are PowerBI, Azure Data Factory, Azure Machine Learning Studio, R and Python) or commensurate education/experience. Minimum 3 years of hands-on experience with enterprise data warehouse solutions including integration of complex data sources for the deployment of decision support systems required. 5+ years experience with an ETL tool, Informatica preferred. 5+ years experience developing and administering dashboards (for example PowerBI, Tableau, or a similar tool) preferred. 5+ years experience in Data Analysis, Database Design and Data Architecture; strong SQL skills preferred. 1+ years experience with cloud based tools preferred. 1+ years experience with R, Python or Machine Learning preferred. Experience with commercial pharmaceutical / business information (SHS, Veeva CRM, Veeva Network, etc.), supply chain, finance and HR is required. Has directly worked with analysts and decision makers in support of decision needs. Experience developing proof of concept prototypes, presenting, advising, and assisting with a wide variety of projects. Ability to prioritize and work multiple assignments, tight deadlines and working well under pressure. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Analyst, Data and Advanced Analytics City Basking Ridge Functional Area Information Technology State New Jersey
01/19/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Responsible for working directly with business partners, business analysts, and other developers in creating scalable solutions which effectively and efficiently satisfy the business decision making needs. Responsible for the design, development, maintenance and distribution of our internal analytics applications to provide reliable data faster to support decision making. The Data and Advanced Analytics Analyst will be assigned to multiple projects which will be spread across several departments in all three divisions of DSI - Daiichi Sankyo Pharma Development (DSPD) Division, the U.S. Commercial Division (USCD) and the Daiichi Sankyo U.S. Business (DSUSB). Look at problems in unique ways, help teams to use data to improve decision making, build innovative custom solutions, and act as a liaison between IT and end users. The position requires a solid understanding of the drivers of the business and the ability to translate these into meaningful analytical tools to support their analytical needs. Responsibilities: Design and develop data and advanced analytics environments that support DSI's functional reporting solutions. Build business intelligence, machine learning and artificial intelligence Design business intelligence capabilities and best practices that are complete and actionable, including performing information analysis in support of designing solutions. Make design recommendations of how to visualize key metrics and performance indicators like ROI, valuation, opportunity, turnover and access. Contribute to the development, testing, and integration of reporting and analysis solutions. Successfully rollout newly developed capabilities from start to finish. Support end-users through informal hands-on usage training and educate users on best practices and business intelligence solutions. Collaborate with business stakeholders to understand their needs for data and advanced analytics environments. Partner with IT stakeholders and vendors for the support of business objectives. Provide ongoing support services and expert knowledge regarding data integration, business intelligence, machine learning and artificial intelligence solutions and platforms. Responsible for the integrity and quality of data and information stored and flowing between business applications, data warehouse, integration hubs and business intelligence applications. Administer and maintain the technology platforms including but not limited to Informatica Cloud, Azure Data Factory and PowerBI Demonstrates high level proficiency for emerging Business Intelligence, Machine Learning and Artificial Intelligence technology, aligning with toolset future roadmaps, keeps informed of latest trends and developments in technologies. Perform additional duties and projects as required by the manager. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's degree in Information Systems, Computer Science or business related discipline. Advanced degrees are a plus but not required. 5 years of hands-on experience in application development, Business intelligence, Data integration, Machine Learning, Artificial Intelligence and advanced analytics with emphasis on Microsoft Azure suite (examples are PowerBI, Azure Data Factory, Azure Machine Learning Studio, R and Python) or commensurate education/experience. Minimum 3 years of hands-on experience with enterprise data warehouse solutions including integration of complex data sources for the deployment of decision support systems required. 5+ years experience with an ETL tool, Informatica preferred. 5+ years experience developing and administering dashboards (for example PowerBI, Tableau, or a similar tool) preferred. 5+ years experience in Data Analysis, Database Design and Data Architecture; strong SQL skills preferred. 1+ years experience with cloud based tools preferred. 1+ years experience with R, Python or Machine Learning preferred. Experience with commercial pharmaceutical / business information (SHS, Veeva CRM, Veeva Network, etc.), supply chain, finance and HR is required. Has directly worked with analysts and decision makers in support of decision needs. Experience developing proof of concept prototypes, presenting, advising, and assisting with a wide variety of projects. Ability to prioritize and work multiple assignments, tight deadlines and working well under pressure. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Analyst, Data and Advanced Analytics City Basking Ridge Functional Area Information Technology State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Position leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical analysis plan and helps in interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also works on statistical methodology and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal programmers in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Responsibilities: Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer. Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines. Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities. Global strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: PhD in statistics or biostatistics or Master's in Statistics/Biostatistics. Ph.D. strongly preferred. Minimum 3 years relevant experience in the pharmaceutical industry with Ph.D. or 5 years with Masters. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, Job Title Manager, Biostatistics City Basking Ridge Functional Area Biostatistics & Data Management State New Jersey
01/19/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Position leads statistical support for medium complexity studies including contributing to development of optimal study design, independently develop and execute statistical analysis plan and helps in interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also works on statistical methodology and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization (CRO) programmers and statisticians and collaborates with internal programmers in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Responsibilities: Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer. Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines. Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities. Global strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: PhD in statistics or biostatistics or Master's in Statistics/Biostatistics. Ph.D. strongly preferred. Minimum 3 years relevant experience in the pharmaceutical industry with Ph.D. or 5 years with Masters. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, Job Title Manager, Biostatistics City Basking Ridge Functional Area Biostatistics & Data Management State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This position oversees and manages US Medical Affairs activities including strategy, communications, and medical affairs directed clinical activities across the oncology portfolio. The position has leadership responsibility for Medical Affairs personnel working on Oncology products that can range from late clinical phases through launch and post-approval in multiple therapeutic areas. In partnership with the Global Medical Affairs and Oncology Business Unit Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on the scientific development and appropriate communication for the products. The position must effectively collaborate with Clinical Development and with Alliance partners to effectively guide the scientific efforts needed in support of Daiichi Sankyo brands. Additionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management, IIS programs and post approval clinical programs in consultation with Oncology Business Unit, Clinical Development and outside experts, and by building the image of the company as a partner in research projects Responsibilities: This position oversees and manages US Medical Affairs activities including strategy, communications, and medical affairs directed clinical activities across the oncology portfolio. The position has leadership responsibility for Medical Affairs personnel working on Oncology products that can range from late clinical phases through launch and post-approval in multiple therapeutic areas. In partnership with the Global Medical Affairs and Oncology Business Unit Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on scientific development and appropriate communication for the products. The position must effectively collaborate with Clinical Development and with Alliance partners to effectively guide the scientific efforts needed in support of Daiichi Sankyo brands. Additionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management, IIS programs and post approval clinical programs in consultation with Oncology Business Unit, Clinical Development and outside experts, and by building the image of the company as a partner in research projects Serve as the face of Daiichi Sankyo US Medical Affairs to external stakeholders. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for interactions with Key External Experts in Oncology including advisory boards, congress activities, investigator initiated studies, advocacy, and sponsorships. Interact with investigators and members of the medical community to assist in understanding current academic, clinical trial and practice issues related to DS Oncology development and therapeutic strategies. Partner across the Oncology Business Unit to oversee and assume responsibility for brand plans, including Medical objectives, strategies and tactics leading up to launch and carrying through to later stages of commercialization. Foster cross-asset, therapeutic area strategies including scientific exchange for biomarkers and companion diagnostics. For Oncology portfolio serve as the US Medical Affairs lead in development committees and global medical affairs activities. Represent Medical Affairs in new product planning, life cycle management, co-development and co-promotion discussions. Foster bidirectional communication and alignment between US and Global Medical Affairs. Oversee the interpretation, publication/ public disclosure and interpretation of scientific data generated by studies conducted by the Oncology teams. Oversee the development of scientific content for medical communication and scientific education initiatives that occur as a result of studies conducted by the Oncology teams as well as strategies related to competitive intelligence. Attract and develop US Medical Affairs talent in oncology. Oversee the team, as well as, develop and effectively manage annual operating plan and budget for the Oncology Medical Strategy Group. Support the US Medical Affairs department through participation on the Medical Affairs Leadership Team and serve as the voice for oncology within the department. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: MD degree preferred, PhD as a minimum requirement; Board Certified/Eligible in Oncology or related specialty preferred, or equivalent clinical or research experience Minimum of 10 years of experience in clinical / research / academic medicine or equivalent pharmaceutical industry experience. Proven track record of working successfully with cross-functional internal teams as well as external stakeholders to achieve goals. Experience with oncology medical strategies and clinical trial implementation is required. The Executive Director will serve as a resource across the Oncology Business Unit and would be expected to have significant knowledge of oncology basic science, mechanisms of action, treatment landscapes and clinical practice patterns across a broad range of therapeutic areas. Excellent written and oral communication skills, particularly strong formal presentation skills; strong interpersonal skills commensurate with the need to work closely with both outside physicians/ scientists and numerous in-house support groups; strong managerial skills to lead effectively and motivate staff; demonstrated high proficiency in problem solving ability and possession of strong scientific analytical skills; excellent planning and organizational skills; experience in setting and adhering to departmental budgets; knowledge of scientific methods, research design and medical practices and procedures that would be acquired through clinical experience and clinical research studies. Basic knowledge of clinical trial design and biostatistics; proficiency using standard software suites Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, TA Lead, Oncology, USMA City Basking Ridge Functional Area DSUSB Medical Affairs State New Jersey
01/19/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This position oversees and manages US Medical Affairs activities including strategy, communications, and medical affairs directed clinical activities across the oncology portfolio. The position has leadership responsibility for Medical Affairs personnel working on Oncology products that can range from late clinical phases through launch and post-approval in multiple therapeutic areas. In partnership with the Global Medical Affairs and Oncology Business Unit Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on the scientific development and appropriate communication for the products. The position must effectively collaborate with Clinical Development and with Alliance partners to effectively guide the scientific efforts needed in support of Daiichi Sankyo brands. Additionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management, IIS programs and post approval clinical programs in consultation with Oncology Business Unit, Clinical Development and outside experts, and by building the image of the company as a partner in research projects Responsibilities: This position oversees and manages US Medical Affairs activities including strategy, communications, and medical affairs directed clinical activities across the oncology portfolio. The position has leadership responsibility for Medical Affairs personnel working on Oncology products that can range from late clinical phases through launch and post-approval in multiple therapeutic areas. In partnership with the Global Medical Affairs and Oncology Business Unit Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on scientific development and appropriate communication for the products. The position must effectively collaborate with Clinical Development and with Alliance partners to effectively guide the scientific efforts needed in support of Daiichi Sankyo brands. Additionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management, IIS programs and post approval clinical programs in consultation with Oncology Business Unit, Clinical Development and outside experts, and by building the image of the company as a partner in research projects Serve as the face of Daiichi Sankyo US Medical Affairs to external stakeholders. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for interactions with Key External Experts in Oncology including advisory boards, congress activities, investigator initiated studies, advocacy, and sponsorships. Interact with investigators and members of the medical community to assist in understanding current academic, clinical trial and practice issues related to DS Oncology development and therapeutic strategies. Partner across the Oncology Business Unit to oversee and assume responsibility for brand plans, including Medical objectives, strategies and tactics leading up to launch and carrying through to later stages of commercialization. Foster cross-asset, therapeutic area strategies including scientific exchange for biomarkers and companion diagnostics. For Oncology portfolio serve as the US Medical Affairs lead in development committees and global medical affairs activities. Represent Medical Affairs in new product planning, life cycle management, co-development and co-promotion discussions. Foster bidirectional communication and alignment between US and Global Medical Affairs. Oversee the interpretation, publication/ public disclosure and interpretation of scientific data generated by studies conducted by the Oncology teams. Oversee the development of scientific content for medical communication and scientific education initiatives that occur as a result of studies conducted by the Oncology teams as well as strategies related to competitive intelligence. Attract and develop US Medical Affairs talent in oncology. Oversee the team, as well as, develop and effectively manage annual operating plan and budget for the Oncology Medical Strategy Group. Support the US Medical Affairs department through participation on the Medical Affairs Leadership Team and serve as the voice for oncology within the department. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: MD degree preferred, PhD as a minimum requirement; Board Certified/Eligible in Oncology or related specialty preferred, or equivalent clinical or research experience Minimum of 10 years of experience in clinical / research / academic medicine or equivalent pharmaceutical industry experience. Proven track record of working successfully with cross-functional internal teams as well as external stakeholders to achieve goals. Experience with oncology medical strategies and clinical trial implementation is required. The Executive Director will serve as a resource across the Oncology Business Unit and would be expected to have significant knowledge of oncology basic science, mechanisms of action, treatment landscapes and clinical practice patterns across a broad range of therapeutic areas. Excellent written and oral communication skills, particularly strong formal presentation skills; strong interpersonal skills commensurate with the need to work closely with both outside physicians/ scientists and numerous in-house support groups; strong managerial skills to lead effectively and motivate staff; demonstrated high proficiency in problem solving ability and possession of strong scientific analytical skills; excellent planning and organizational skills; experience in setting and adhering to departmental budgets; knowledge of scientific methods, research design and medical practices and procedures that would be acquired through clinical experience and clinical research studies. Basic knowledge of clinical trial design and biostatistics; proficiency using standard software suites Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, TA Lead, Oncology, USMA City Basking Ridge Functional Area DSUSB Medical Affairs State New Jersey
Join a Legacy of Innovation 110 Years and Counting! With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Please note this is a REMOTE role and can be done from anywhere in the United States. This role does require 35-40% travel to our HQ in Basking Ridge, NJ. Job Summary: The Associate Director, Field Medical Training will be responsible for the development, implementation, and continuous improvement of a strategic and comprehensive training curricula for Medical Science Liaisons (MSL), Health Outcomes Liaisons (HOL) and other Medical Affairs Employees and Contingent Workers requiring therapeutic knowledge of the Daiichi Sankyo portfolio. The Associate Director, Field Medical Training will have a variety of responsibilities that support both the department's vision and purpose. Primary responsibilities include: Creation, implementation and regular update of on-boarding (initial) and continuing education/training of FMA colleagues in therapeutics, health economics, technical systems and core skills including the development of an annual training plan and alignment of all key stakeholders for the development and pull through of the annual training plan for optimal effectiveness on Field Medical and Medical Affairs. Development conduct and monitoring of the FMA mentor training program. Leadership, support and system administration for the FMA knowledge management system(s) Responsibilities: Training Program Development & Facilitation Curricula development including the creation, implementation, assessment and regular update of FMA colleague on-boarding (initial) and continuing education/training, and mentor program. Curriculum to encompass scientific/therapeutic, technical and environment knowledge, customer/business acumen and communication skill components to assure that FMA colleagues have the knowledge and skills to quickly become effective in the role. Hematology and Oncology scientific, therapeutic and environmental curricula encompassing all tumor types and associated products, diagnostics and support measures for Cancer Enterprise areas of interest. Training Strategy & Effectiveness Responsible for the development and implementation of an Annual Training Plan (including a standardized approach to handling customer relationship management, marketplace events & activity/workload reporting) to maximize field effectiveness & preparedness. Responsibilities would include the creation of a Training Effectiveness Program and establishment of KPIs to evaluate effectiveness of training. Special Projects and Other Departmental Support Overseeing vendors and internal personnel to ensure the successful design, development and roll-out of training programs, projects, or key meetings. Assist in the evaluating, selecting and managing department vendor and procurement processes. Systems administration including the integration of FMA business needs with technological systems to facilitate activity/workload reporting, knowledge management and compliance management Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Pharmacist, PharmD, or Ph.D. in a health sciences related field Content/Curricula or Training certifications preferred in adult learning training content 8 years of experience including medical & scientific affairs, with 2 or more years of experience as a medical liaison in the pharmaceutical industry preferred 2 or more years of experience in the areas of training, and systems (document and slide development/centralization; activity logs/reporting; other) is preferred including training certification. Experience in the areas of organizational effectiveness and systems (document and slide development/centralization; activity logs/reporting; other) is preferred Previous experience in Oncology or Hematology is required. Must have ability to travel overnight 35-40% of time, especially to our HQ in Basking Ridge, NJ Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Associate Director, USMA Field Medical Training (US-Remote) City New York Functional Area DSUSB Medical Affairs State New York
01/19/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Please note this is a REMOTE role and can be done from anywhere in the United States. This role does require 35-40% travel to our HQ in Basking Ridge, NJ. Job Summary: The Associate Director, Field Medical Training will be responsible for the development, implementation, and continuous improvement of a strategic and comprehensive training curricula for Medical Science Liaisons (MSL), Health Outcomes Liaisons (HOL) and other Medical Affairs Employees and Contingent Workers requiring therapeutic knowledge of the Daiichi Sankyo portfolio. The Associate Director, Field Medical Training will have a variety of responsibilities that support both the department's vision and purpose. Primary responsibilities include: Creation, implementation and regular update of on-boarding (initial) and continuing education/training of FMA colleagues in therapeutics, health economics, technical systems and core skills including the development of an annual training plan and alignment of all key stakeholders for the development and pull through of the annual training plan for optimal effectiveness on Field Medical and Medical Affairs. Development conduct and monitoring of the FMA mentor training program. Leadership, support and system administration for the FMA knowledge management system(s) Responsibilities: Training Program Development & Facilitation Curricula development including the creation, implementation, assessment and regular update of FMA colleague on-boarding (initial) and continuing education/training, and mentor program. Curriculum to encompass scientific/therapeutic, technical and environment knowledge, customer/business acumen and communication skill components to assure that FMA colleagues have the knowledge and skills to quickly become effective in the role. Hematology and Oncology scientific, therapeutic and environmental curricula encompassing all tumor types and associated products, diagnostics and support measures for Cancer Enterprise areas of interest. Training Strategy & Effectiveness Responsible for the development and implementation of an Annual Training Plan (including a standardized approach to handling customer relationship management, marketplace events & activity/workload reporting) to maximize field effectiveness & preparedness. Responsibilities would include the creation of a Training Effectiveness Program and establishment of KPIs to evaluate effectiveness of training. Special Projects and Other Departmental Support Overseeing vendors and internal personnel to ensure the successful design, development and roll-out of training programs, projects, or key meetings. Assist in the evaluating, selecting and managing department vendor and procurement processes. Systems administration including the integration of FMA business needs with technological systems to facilitate activity/workload reporting, knowledge management and compliance management Qualifications Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Pharmacist, PharmD, or Ph.D. in a health sciences related field Content/Curricula or Training certifications preferred in adult learning training content 8 years of experience including medical & scientific affairs, with 2 or more years of experience as a medical liaison in the pharmaceutical industry preferred 2 or more years of experience in the areas of training, and systems (document and slide development/centralization; activity logs/reporting; other) is preferred including training certification. Experience in the areas of organizational effectiveness and systems (document and slide development/centralization; activity logs/reporting; other) is preferred Previous experience in Oncology or Hematology is required. Must have ability to travel overnight 35-40% of time, especially to our HQ in Basking Ridge, NJ Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Associate Director, USMA Field Medical Training (US-Remote) City New York Functional Area DSUSB Medical Affairs State New York
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Clinical Safety will coordinate and lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Sankyo's development compounds. This individual will use strong leadership and communication to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role will partner with Integrated Development Team members in Clinical, Regulatory, Project Management, Biostatistics, and Pharmacology, and other key stakeholders in strategically managing benefit-risk throughout the lifecycle of the drug. Responsibilities: Develop processes and procedures for identifying and evaluating risk management issues for compounds in development. Review and analyze data from clinical trials for the prompt identification of safety Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk management assessment of assigned projects/products. Define and implement strategies and action plans for managing risk management issues throughout the product life cycle. Effectively coordinate and manage available resources in developing and delivering high-quality risk management documents/deliverables (e.g., Risk Management Plans) to agreed timelines. Coordinate and participate actively and influentially in regulatory risk management activities (e.g., regulatory meetings, post-approval commitments). Effectively represent Risk Management on the project Integrated Development Team providing risk management support and serving as the primary point of contact. Ensure compliance with regulatory standards and guidelines and corporate SOPs as they relate to risk management. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: MD or PhD in a relevant scientific discipline 7-10 years experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology. Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist. Ability to review and analyze data and communicate complex information and analyses to a variety of scientific and non-scientific audiences. Proven ability to think creatively and to develop strategic plans that demonstrate sound judgment. Experience working cross-culturally in a global pharmaceutical environment. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Clinical Safety City Basking Ridge Functional Area CSPV State New Jersey
01/19/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Clinical Safety will coordinate and lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Sankyo's development compounds. This individual will use strong leadership and communication to successfully coordinate resources and ensure effective collaboration across development functions and sites. The individual assuming this role will partner with Integrated Development Team members in Clinical, Regulatory, Project Management, Biostatistics, and Pharmacology, and other key stakeholders in strategically managing benefit-risk throughout the lifecycle of the drug. Responsibilities: Develop processes and procedures for identifying and evaluating risk management issues for compounds in development. Review and analyze data from clinical trials for the prompt identification of safety Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk management assessment of assigned projects/products. Define and implement strategies and action plans for managing risk management issues throughout the product life cycle. Effectively coordinate and manage available resources in developing and delivering high-quality risk management documents/deliverables (e.g., Risk Management Plans) to agreed timelines. Coordinate and participate actively and influentially in regulatory risk management activities (e.g., regulatory meetings, post-approval commitments). Effectively represent Risk Management on the project Integrated Development Team providing risk management support and serving as the primary point of contact. Ensure compliance with regulatory standards and guidelines and corporate SOPs as they relate to risk management. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: MD or PhD in a relevant scientific discipline 7-10 years experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology. Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist. Ability to review and analyze data and communicate complex information and analyses to a variety of scientific and non-scientific audiences. Proven ability to think creatively and to develop strategic plans that demonstrate sound judgment. Experience working cross-culturally in a global pharmaceutical environment. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Clinical Safety City Basking Ridge Functional Area CSPV State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least one therapeutic area or a large, global Phase 3/4 program. This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this position regularly interfaces with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge. This position independently addresses the most complex safety issues and acts as the final decision-maker, approving various safety documents. Overall, this position has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program. Responsibilities: Safety Expert - Overall: Serves as the safety expert for the TA or product and company expert on drug safety topics. Responsible for safety governance/oversight of Clinical Safety and risk management activities. Oversees RMP for a major product or multiples products within at least one TA. Safety Expert - Signal Identification: Formulates strategic approaches to signal identification, trains junior staff, and educates the company. Works closely with others to identify/obtain new signal identification tools that are useful for global surveillance. Safety Expert - Signal Evaluation: Formulates strategic approaches to signal evaluation and trains junior staff. Primarily responsible for the final comprehensive assessment of safety data. Works closely with others to identify/obtain innovative signal evaluation tools that are useful for global assessments. Safety Expert - Risk Mitigation & Communication: Formulates strategic approaches for risk mitigation for global products/TAs and ensures these activities are properly carried out. Serves as company expert for risk mitigation and oversees the global communication of important product safety information. Oversees the identification and retention of external partners/CROs for effective risk mitigation for assigned products. Reports and Submissions: Oversees safety sections for NDA submissions. Effectively drives TA products through the approval process and serves as lead CSPV representative for key regulatory interactions associated with NDA/MAA approval. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Requires MD degree 8 years of experience and board eligibility Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Clinical Safety City Basking Ridge Functional Area CSPV State New Jersey
01/19/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at least one therapeutic area or a large, global Phase 3/4 program. This position identifies and selects resources/tools to facilitate risk management during development and post-market. Additionally, this position regularly interfaces with key high-level internal and external stakeholders and approves regulatory reports/submissions using expert safety knowledge. This position independently addresses the most complex safety issues and acts as the final decision-maker, approving various safety documents. Overall, this position has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program. Responsibilities: Safety Expert - Overall: Serves as the safety expert for the TA or product and company expert on drug safety topics. Responsible for safety governance/oversight of Clinical Safety and risk management activities. Oversees RMP for a major product or multiples products within at least one TA. Safety Expert - Signal Identification: Formulates strategic approaches to signal identification, trains junior staff, and educates the company. Works closely with others to identify/obtain new signal identification tools that are useful for global surveillance. Safety Expert - Signal Evaluation: Formulates strategic approaches to signal evaluation and trains junior staff. Primarily responsible for the final comprehensive assessment of safety data. Works closely with others to identify/obtain innovative signal evaluation tools that are useful for global assessments. Safety Expert - Risk Mitigation & Communication: Formulates strategic approaches for risk mitigation for global products/TAs and ensures these activities are properly carried out. Serves as company expert for risk mitigation and oversees the global communication of important product safety information. Oversees the identification and retention of external partners/CROs for effective risk mitigation for assigned products. Reports and Submissions: Oversees safety sections for NDA submissions. Effectively drives TA products through the approval process and serves as lead CSPV representative for key regulatory interactions associated with NDA/MAA approval. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Requires MD degree 8 years of experience and board eligibility Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Clinical Safety City Basking Ridge Functional Area CSPV State New Jersey
About Daiichi Sankyo Cancer Enterprise The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Job Summary: Lead Clinical Scientist or Global Clinical Leader for one or more early Breakthrough Science or Antibody-Drug Conjugate (ADC) clinical assets. Responsible for establishment and execution of clinical drug development strategy. Consults with scientists in Research Labs to deliver non-clinical package necessary to support translation into clinical program. Design and oversight of Phase I first-in-man clinical trials, in addition to more advanced PhIb combination and PhII multinational clinical trials. Provides Medical input and monitoring for active trials. Works closely with Translational Science and Translational Research (Biomarker and CDx) functions to incorporate appropriate assays and plan into the clinical program. Drafts clinical development plans and protocol profiles, and works with team on clinical protocols and investigator's brochure; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Reviews regulatory documents from cross functional, holistic perspective; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters and represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Supports marketing in developing a commercial strategy include biomarker strategy; Supports Business Development and Licensing for evaluation of new assets. Represents Clinical Development as Global Clinical Lead or as Team Leader Responsibilities Program and Study Strategy: Works with cross-functional team to develop comprehensive clinical strategy for program, and studies needed to address this. Lead development of protocol profile to answer key clinical/scientific questions on compound. Work closely with Research, Quantitative Clinical Pharmacology, Translational Science , Translational Research, Statistics, Clinical Operations, Regulatory, and other cross-functional team members colleagues on protocols. Develops biomarker strategy in collaboration with Translational Science, Collaborates with external KOLs to refine study plans; Defines study strategy across clinical trials within an indication or project Study Planning and Execution: Provides the strategic direction to Data Management for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develop prospective contingency plans for management of key risks in a large study or project; Clearly define study priorities and high level execution plan, communicate to members of study team within sponsor, CRO and vendors; Ensure clear and effective lines of communication and decision-making process cross-functionally and cross-regionally; Facilitate team coordination Study outputs: Drafts responses to IRBs and HA, Collaborates with QCP and Translational Science to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead e.g. review TLG before DBL, and quality check of data, Works with Data Management to ensure SAP updates; Interpret study results in context of other studies in the project and other drugs used for the indication Medical monitoring planning: For large Phase 3 studies: Reviews, edits, approves and updates medical monitoring plan, Develops SAE flow plan for AESI in conjunction w/ CSPV, Defines medical monitoring oversight component, Sets up DSMB and/or adjudication committee (as needed); Develops medical content for protocol profile, protocol and amendments; Direct CRO medical monitor activities for a large study and/or across a program Medical surveillance: (MD only) For studies within a project: Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical monitoring activities, Reviews data before DBL from medical perspective, assist BDO in creation of TFG, Reviews, oversees creation of patient narratives, Provides medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and interpretations, e.g. language for IB; Documents ongoing MM review of data for safety (with CSPV) and quality at project level External collaboration: Engages with top tier KOLs for project level strategic advice and advisory boards; Develops and leads steering committee for key trials; Consults with KOLS for advice on complex development or safety issues Scientific, Program related: Clinical Study Team (CST) leader on study team; Responsible before senior management for the creation and execution of development strategies for program/s under CST or GPT; Obtains cross-functional alignment ; Leads development and execution of Product Development Plan and clinical development strategy; Key Core member of Global Project Team (GPT) working closely with Global Project Management to ensure cross-functional coordination and focus to agreed strategy; Coordinates clinical activities across the project. Works with team members to drive peer-reviewed publications and external presentations (conferences) related to program. People management: Leads large study or project teams involving multiple functions and many members with or without a direct reporting relationship Additional non-study related activities: Provides input on KOL selection for Therapeutic Area; Reviews content to be shared with KOLs; Frequent involvement in Business Development activities for early stage or preclinical assets; Involvement with in-licensing and acquisitions on due diligence activities; Major contributor to portfolio decisions Qualifications Education MD highly preferred, PharmD, PhD or equivalent with exceptional qualifications acceptable; Postgraduate training in Oncology or Hematology, or meaningful past in field. Experience 5 Years Competencies Strategic Thinking, Clinical Trials Knowledge, Influencing Skills, Scientific Knowledge, Oncology Expertise, Drug Development, Critical Thinking, Team Leadership Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Global Oncology R&D City Basking Ridge Functional Area Global Oncology R&D State New Jersey
01/19/2021
Full time
About Daiichi Sankyo Cancer Enterprise The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Job Summary: Lead Clinical Scientist or Global Clinical Leader for one or more early Breakthrough Science or Antibody-Drug Conjugate (ADC) clinical assets. Responsible for establishment and execution of clinical drug development strategy. Consults with scientists in Research Labs to deliver non-clinical package necessary to support translation into clinical program. Design and oversight of Phase I first-in-man clinical trials, in addition to more advanced PhIb combination and PhII multinational clinical trials. Provides Medical input and monitoring for active trials. Works closely with Translational Science and Translational Research (Biomarker and CDx) functions to incorporate appropriate assays and plan into the clinical program. Drafts clinical development plans and protocol profiles, and works with team on clinical protocols and investigator's brochure; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Reviews regulatory documents from cross functional, holistic perspective; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters and represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Supports marketing in developing a commercial strategy include biomarker strategy; Supports Business Development and Licensing for evaluation of new assets. Represents Clinical Development as Global Clinical Lead or as Team Leader Responsibilities Program and Study Strategy: Works with cross-functional team to develop comprehensive clinical strategy for program, and studies needed to address this. Lead development of protocol profile to answer key clinical/scientific questions on compound. Work closely with Research, Quantitative Clinical Pharmacology, Translational Science , Translational Research, Statistics, Clinical Operations, Regulatory, and other cross-functional team members colleagues on protocols. Develops biomarker strategy in collaboration with Translational Science, Collaborates with external KOLs to refine study plans; Defines study strategy across clinical trials within an indication or project Study Planning and Execution: Provides the strategic direction to Data Management for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develop prospective contingency plans for management of key risks in a large study or project; Clearly define study priorities and high level execution plan, communicate to members of study team within sponsor, CRO and vendors; Ensure clear and effective lines of communication and decision-making process cross-functionally and cross-regionally; Facilitate team coordination Study outputs: Drafts responses to IRBs and HA, Collaborates with QCP and Translational Science to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead e.g. review TLG before DBL, and quality check of data, Works with Data Management to ensure SAP updates; Interpret study results in context of other studies in the project and other drugs used for the indication Medical monitoring planning: For large Phase 3 studies: Reviews, edits, approves and updates medical monitoring plan, Develops SAE flow plan for AESI in conjunction w/ CSPV, Defines medical monitoring oversight component, Sets up DSMB and/or adjudication committee (as needed); Develops medical content for protocol profile, protocol and amendments; Direct CRO medical monitor activities for a large study and/or across a program Medical surveillance: (MD only) For studies within a project: Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical monitoring activities, Reviews data before DBL from medical perspective, assist BDO in creation of TFG, Reviews, oversees creation of patient narratives, Provides medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and interpretations, e.g. language for IB; Documents ongoing MM review of data for safety (with CSPV) and quality at project level External collaboration: Engages with top tier KOLs for project level strategic advice and advisory boards; Develops and leads steering committee for key trials; Consults with KOLS for advice on complex development or safety issues Scientific, Program related: Clinical Study Team (CST) leader on study team; Responsible before senior management for the creation and execution of development strategies for program/s under CST or GPT; Obtains cross-functional alignment ; Leads development and execution of Product Development Plan and clinical development strategy; Key Core member of Global Project Team (GPT) working closely with Global Project Management to ensure cross-functional coordination and focus to agreed strategy; Coordinates clinical activities across the project. Works with team members to drive peer-reviewed publications and external presentations (conferences) related to program. People management: Leads large study or project teams involving multiple functions and many members with or without a direct reporting relationship Additional non-study related activities: Provides input on KOL selection for Therapeutic Area; Reviews content to be shared with KOLs; Frequent involvement in Business Development activities for early stage or preclinical assets; Involvement with in-licensing and acquisitions on due diligence activities; Major contributor to portfolio decisions Qualifications Education MD highly preferred, PharmD, PhD or equivalent with exceptional qualifications acceptable; Postgraduate training in Oncology or Hematology, or meaningful past in field. Experience 5 Years Competencies Strategic Thinking, Clinical Trials Knowledge, Influencing Skills, Scientific Knowledge, Oncology Expertise, Drug Development, Critical Thinking, Team Leadership Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Global Oncology R&D City Basking Ridge Functional Area Global Oncology R&D State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Process Excellence & Standards will set strategy and direction for the Process Excellence & Standards organization within Global Clinical Operations & Planning and play a key role in implementing and maintaining a continuous process improvement framework for the design and implementation of end-to-end clinical trial processes including rollout of a Process Council, kick-off of cross-functional Process Teams, and implementation of new roles (Process Owner and Process Manager/Specialist). Under the leadership of the Sr. Director, the Process Excellence & Standards group will also be responsible for developing process documentation and SOPs, GCP training and broader Learning and Development activities, metrics & benchmarking, and clinical quality management including tracking of GCP deviations/nonconformances, CAPA management, and inspection readiness. Responsibilities: Set strategy and direction for the Process Excellence & Standards Center of Excellence within Global Clinical Operations & Planning encompassing business process management, training, and clinical quality management Partner with functional leaders and Process Owners to shape and implement a continuous process improvement (CPI) framework for end-to-end clinical trial processes including rollout of Process Council, kick-off of Process Teams, and implementation of Process Owner and Process Manager/Specialist roles Serve as Chief of Staff for the Process Council, working with the committee chairs, members, and Process Teams to facilitate high-level governance of process improvement (strategy, prioritization, guidance, support and issue resolution) and maintenance of a continuous improvement plan for DS's portfolio of processes Establish a Process Owner/Process Manager forum to drive the change to CPI model and ensure consistency/connectivity across processes. In addition, keeps abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to processes and proactively initiates discussions and process changes Work with Process Managers and Metrics/Benchmarking lead to ensure that appropriate process performance metrics are maintained and actively deployed to diagnose and address process gaps/deficiencies Support the efforts of Process Owners/Process Managers to drive change management and implementation of major process design changes Partner with QA to ensure that clinical SOPs and GCP training are up-to-date, GCP deviations/nonconformances are tracked and addressed, and to ensure inspection readiness and CAPA management for items under GCO responsibility Shape training and development strategies of GCOP staff through deployment of a GCO training center of excellence Recruit, train, coach and develop staff to ensure development and deployment of key capabilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 10 years' experience in pharmaceutical or biotechnology drug development. Significant experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, clinical QA) Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements Strong leadership, collaboration, and influencing skills including team leadership or functional management Experience in clinical trial process design, harmonization/optimization, process implementation, and change management Knowledge and understanding of GCPs and applicable regulatory guidelines governing clinical trials and clinical quality management Experience with delivering presentations before executive staff Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships Effective and influential communication, self-management, problem solving and organizational skills Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Process Excellence & CRO Alliance Mgmt City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
01/15/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Process Excellence & Standards will set strategy and direction for the Process Excellence & Standards organization within Global Clinical Operations & Planning and play a key role in implementing and maintaining a continuous process improvement framework for the design and implementation of end-to-end clinical trial processes including rollout of a Process Council, kick-off of cross-functional Process Teams, and implementation of new roles (Process Owner and Process Manager/Specialist). Under the leadership of the Sr. Director, the Process Excellence & Standards group will also be responsible for developing process documentation and SOPs, GCP training and broader Learning and Development activities, metrics & benchmarking, and clinical quality management including tracking of GCP deviations/nonconformances, CAPA management, and inspection readiness. Responsibilities: Set strategy and direction for the Process Excellence & Standards Center of Excellence within Global Clinical Operations & Planning encompassing business process management, training, and clinical quality management Partner with functional leaders and Process Owners to shape and implement a continuous process improvement (CPI) framework for end-to-end clinical trial processes including rollout of Process Council, kick-off of Process Teams, and implementation of Process Owner and Process Manager/Specialist roles Serve as Chief of Staff for the Process Council, working with the committee chairs, members, and Process Teams to facilitate high-level governance of process improvement (strategy, prioritization, guidance, support and issue resolution) and maintenance of a continuous improvement plan for DS's portfolio of processes Establish a Process Owner/Process Manager forum to drive the change to CPI model and ensure consistency/connectivity across processes. In addition, keeps abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to processes and proactively initiates discussions and process changes Work with Process Managers and Metrics/Benchmarking lead to ensure that appropriate process performance metrics are maintained and actively deployed to diagnose and address process gaps/deficiencies Support the efforts of Process Owners/Process Managers to drive change management and implementation of major process design changes Partner with QA to ensure that clinical SOPs and GCP training are up-to-date, GCP deviations/nonconformances are tracked and addressed, and to ensure inspection readiness and CAPA management for items under GCO responsibility Shape training and development strategies of GCOP staff through deployment of a GCO training center of excellence Recruit, train, coach and develop staff to ensure development and deployment of key capabilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 10 years' experience in pharmaceutical or biotechnology drug development. Significant experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, clinical QA) Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements Strong leadership, collaboration, and influencing skills including team leadership or functional management Experience in clinical trial process design, harmonization/optimization, process implementation, and change management Knowledge and understanding of GCPs and applicable regulatory guidelines governing clinical trials and clinical quality management Experience with delivering presentations before executive staff Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships Effective and influential communication, self-management, problem solving and organizational skills Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Process Excellence & CRO Alliance Mgmt City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Executive Director, Clinical Trial Business Operations will set strategy and direction for the Clinical Trial Business Operations organization within Global Clinical Operations & Planning (GCOP) and as a key member of the GCOP Leadership Team will also contribute to shaping and implementing operational and talent strategies across GCOP. This position will provide leadership and oversight of several key functions including Regional Site Engagement Management (RSEM), Trial Feasibility & Site Identification, Clinical Records & Systems, Study/Resource Planning, and Biosample Operations. This includes creating or enhancing Site Engagement, Feasibility, and Study Planning capabilities in line with DELTA and Development Operations strategies. Responsibilities: Set strategy and direction for the Clinical Trial Business Operations organization within Global Clinical Operations & Planning (GCOP) encompassing Regional Site Engagement Management (RSEM), Feasibility & Site Identification, Clinical Records & Systems, Study/Resource Planning, and Biosample Operations. Oversee the creation and deployment of the new global RSEM organization, ensuring that effective regional and site-specific engagement strategies are developed and implemented and that relationships with key sites are optimized with a positive impact on site performance & metrics. Ensure this capability is leveraged to provide key information for site selection and to enhance the ability of sites to better support the conduct of Daiichi-Sankyo studies. Guide the creation and deployment of the new Feasibility & Site Identification organization and champion the development and utilization of effective analytical tools that inform trial feasibility assessments, site selection decisions, timeline planning, and risk mitigation strategies. Provide the necessary leadership and support to enable creation and effective implementation of a specialized Study/Resource Planning function designed to enhance planning and execution of studies across clinical study teams. Ensure this role is successfully integrated into the organization, including strong partnerships with Global Clinical Operations (Study Management) and Global Project Management. Ensure that the Clinical Records & Systems organization delivers on its expanded mission to identify, maintain, and optimize clinical systems and solutions supporting Clinical Development Operations and broader DSPD functions, globally. This includes key systems such as eTMF Vault, CTMS, and other yet to be defined clinical systems and legacy systems and processes. Stay abreast of emerging technology trends and influence key stakeholders in the organization as needed to shape and adopt new clinical trial technologies. As a member of the GCOP Leadership Team, actively contribute to shaping and implementing key GCOP strategies and plans including talent and organizational strategies, processes, and technologies. Define and implement talent strategies across Clinical Trial Business Operations that result in identification and development of key talent/capabilities and drive a high level of performance, accountability, and employee engagement across the organization Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 15 years' experience in pharmaceutical or biotechnology drug development. Broad knowledge and experience in global clinical trial planning and execution Senior management experience in clinical operations/clinical trial management & enabling technology solutions or related field, leading a medium to large organization and influencing senior-level management and key stakeholders. Includes strong track record of leadership of multiple clinical operations functions with 5+ years of line management experience including management of senior staff with accountability to therapeutic area development teams (highly matrixed organization) and management of staff across multiple sites/regions. Demonstrated ability to design and lead organizational and process /systems changes in a highly matrixed global environment Ability to provide leadership and to foster a collaborative, highly integrated culture, providing leadership and ability to enable transformative change to the Clinical Trial Business Operations team as required to deliver goals Ability to define core competencies, create infrastructure and set up strategic roadmap for delivery of Clinical Trial Business Operations goals Experience managing operational and resource budgets Experience with management of outsourced work and CRO governance Effective and influential communication, self-management, problem solving and organizational skills Demonstrated ability to build and maintain strong internal and external partnerships and coalitions, and to effectively collaborate across the organization Experience with delivering presentations before executive staff Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating through ambiguity Expert knowledge of ICH/GCPs and existing and emerging global, regional, and local country regulatory and compliance requirements for clinical research (Americas, Europe, Asia and Japan); experience with global regulations and global regulatory inspections is required. Familiarity with industry interpretations to ensure compliance while reducing complexity is desired Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Clinical Trial Business Operations City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
01/15/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Executive Director, Clinical Trial Business Operations will set strategy and direction for the Clinical Trial Business Operations organization within Global Clinical Operations & Planning (GCOP) and as a key member of the GCOP Leadership Team will also contribute to shaping and implementing operational and talent strategies across GCOP. This position will provide leadership and oversight of several key functions including Regional Site Engagement Management (RSEM), Trial Feasibility & Site Identification, Clinical Records & Systems, Study/Resource Planning, and Biosample Operations. This includes creating or enhancing Site Engagement, Feasibility, and Study Planning capabilities in line with DELTA and Development Operations strategies. Responsibilities: Set strategy and direction for the Clinical Trial Business Operations organization within Global Clinical Operations & Planning (GCOP) encompassing Regional Site Engagement Management (RSEM), Feasibility & Site Identification, Clinical Records & Systems, Study/Resource Planning, and Biosample Operations. Oversee the creation and deployment of the new global RSEM organization, ensuring that effective regional and site-specific engagement strategies are developed and implemented and that relationships with key sites are optimized with a positive impact on site performance & metrics. Ensure this capability is leveraged to provide key information for site selection and to enhance the ability of sites to better support the conduct of Daiichi-Sankyo studies. Guide the creation and deployment of the new Feasibility & Site Identification organization and champion the development and utilization of effective analytical tools that inform trial feasibility assessments, site selection decisions, timeline planning, and risk mitigation strategies. Provide the necessary leadership and support to enable creation and effective implementation of a specialized Study/Resource Planning function designed to enhance planning and execution of studies across clinical study teams. Ensure this role is successfully integrated into the organization, including strong partnerships with Global Clinical Operations (Study Management) and Global Project Management. Ensure that the Clinical Records & Systems organization delivers on its expanded mission to identify, maintain, and optimize clinical systems and solutions supporting Clinical Development Operations and broader DSPD functions, globally. This includes key systems such as eTMF Vault, CTMS, and other yet to be defined clinical systems and legacy systems and processes. Stay abreast of emerging technology trends and influence key stakeholders in the organization as needed to shape and adopt new clinical trial technologies. As a member of the GCOP Leadership Team, actively contribute to shaping and implementing key GCOP strategies and plans including talent and organizational strategies, processes, and technologies. Define and implement talent strategies across Clinical Trial Business Operations that result in identification and development of key talent/capabilities and drive a high level of performance, accountability, and employee engagement across the organization Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 15 years' experience in pharmaceutical or biotechnology drug development. Broad knowledge and experience in global clinical trial planning and execution Senior management experience in clinical operations/clinical trial management & enabling technology solutions or related field, leading a medium to large organization and influencing senior-level management and key stakeholders. Includes strong track record of leadership of multiple clinical operations functions with 5+ years of line management experience including management of senior staff with accountability to therapeutic area development teams (highly matrixed organization) and management of staff across multiple sites/regions. Demonstrated ability to design and lead organizational and process /systems changes in a highly matrixed global environment Ability to provide leadership and to foster a collaborative, highly integrated culture, providing leadership and ability to enable transformative change to the Clinical Trial Business Operations team as required to deliver goals Ability to define core competencies, create infrastructure and set up strategic roadmap for delivery of Clinical Trial Business Operations goals Experience managing operational and resource budgets Experience with management of outsourced work and CRO governance Effective and influential communication, self-management, problem solving and organizational skills Demonstrated ability to build and maintain strong internal and external partnerships and coalitions, and to effectively collaborate across the organization Experience with delivering presentations before executive staff Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating through ambiguity Expert knowledge of ICH/GCPs and existing and emerging global, regional, and local country regulatory and compliance requirements for clinical research (Americas, Europe, Asia and Japan); experience with global regulations and global regulatory inspections is required. Familiarity with industry interpretations to ensure compliance while reducing complexity is desired Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Executive Director, Clinical Trial Business Operations City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
Join a Legacy of Innovation 110 Years and Counting! With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Job Summary: The Global Medical Affairs (GMA) Project Manager provides strategic planning & operational management oversight of GMA projects, activities, and budgets. The GMA Project Manager is responsible for supporting the Head, Project Management & Operational Excellence, the assigned GMAT or Functional Lead, and the Franchise Head to deliver GMA projects & activities successfully & in a timely manner while working in a fast-moving, matrixed organization The GMA Project Manager is responsible acting as the "Chief of Staff" for his/her team, leading efforts to achieve overall operational excellence across all activities & projects to accelerate business in a compliant & efficient manner. The GMA Project Manager further contributes to accelerating & optimizing the business via the following responsibilities/activities: Budget management & oversight of contract-to-purchase order (PO) process Facilitating key meetings (internal GMA, cross-functional, cross-regional, vendor meetings, etc.) Tracking of activities in terms of timing, anticipated risk, and mitigation of issues/conflict resolutions Leading / contributing to process improvement initiatives Encouraging overall operational excellence across all activities & projects Escalating issues in a timely manner Ensuring streamlined & efficient communication Responsibilities: GMAT/Function Support In close collaboration with the Team Lead (GMAT or Function), establish a strategic plan for monitoring the activities per the Business Plan & priorities. Support Team Lead to manage GMA project/activities, including ensuring that the GMAT/Function team delivers projects/activities successfully and on a timely manner as per annual plan & objectives. Establish milestones and metrics, in collaboration with GMAT/Function team, and develop a detailed project plan in order to track progress and measure impact of the activity. Generates critical path analyses and supports scenario planning for each GMAT/Function, in order to assess if objectives are met, exceeded, or not met. Have a strong understanding of activities, associated budget, and key contributing factors in order to anticipate potential risks and establish plan to mitigate, as appropriate. Lead and facilitate regular internal GMA & cross-functional/cross-regional team meetings; ensure agendas and team priorities are clear, meetings minutes are distributed, action items are completed. Lead the budget planning and tracking process for GMAT/Function team; work with GMAT/Function Leads to provide consolidated budget/LE updates (across all activities and regions) in a timely manner with appropriate rationale. Support GMAT/Function lead with annual Business Planning process & associated documents, including proactive engagement with internal and external stakeholders to manage plan development. Support GMAT/Function/Franchise Head in prioritization and planning of resources and develop rationale for annual resource planning. Lead issue resolution meetings. Lead risk identification, prioritization and mitigation planning processes across the Franchise. Manage the agendas for GMAT/Function meetings, the conduct of the GMAT/Function meetings, and the drafting of GMAT/Function meeting minutes. Ensure full documentation of meeting discussions, decisions and action items. Track & ensure completion of agreed action items. Ensure appropriate archiving of project documentation. Develop a monthly report that provides an overview of progress on all key activities, potential risks and mitigation actions. Generate and maintains strategic integrated GMA Franchise project plans, project timelines, high quality risk management plans, and communication plans, as needed. Liaise with DS Corporate Finance, Legal, and Procurement teams, as necessary, to ensure activities are executed efficiently and in compliance with company policies and procedures. Operational Excellence Support Collaborate with Head, Project Management & Operational Excellence to further strengthen operational excellence from a GMA-wide organization perspective. Disseminate key leadership communications throughout GMAT/Functional teams and lead issue escalation efforts when required. Identify gaps in Global Medical Affairs processes and functional procedures that (potentially) impact program delivery and escalate appropriately to Head, Project Management & Operational Excellence. Collaborate with Head, Project Management & Operational Excellence and GMAT/Functional Leads for formal presentations/communications to GMA Head and Senior management. Support Head, Project Management & Operational Excellence with monthly and annual updates to Senior leadership. Integrate operational excellence best practices into regular team meetings and communications to enhance overall capabilities. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Bachelor's degree with relevant professional experience or equivalent; advanced degree desirable. PMP or similar professional project management certification is a plus Minimum 7 year experience in pharma industry of which 5 years PM experience. Strong project management experience. PMP, Six Sigma or similar professional project management certification is a plus Demonstrated leadership skills, especially in areas of communication and change management Meticulous attention to detail in all aspects of work and expert organization skills Proven ability to drive decision making process, including ability to challenge teams and achieve excellence Ability to thrive in a fast-paced environment Self-starter, results-oriented Strong change management skills and engagement to enable continuous improvement Strong communication skills and ability to adapt according to different levels of management Ability to negotiate and align across franchise Demonstrated ability to collaborate effectively with key stakeholders Strong Microsoft Excel & PowerPoint skills required, SAP experience a plus Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Director, GMA Oncology, Project Management City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey
09/29/2020
Full time
Join a Legacy of Innovation 110 Years and Counting! With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. Job Summary: The Global Medical Affairs (GMA) Project Manager provides strategic planning & operational management oversight of GMA projects, activities, and budgets. The GMA Project Manager is responsible for supporting the Head, Project Management & Operational Excellence, the assigned GMAT or Functional Lead, and the Franchise Head to deliver GMA projects & activities successfully & in a timely manner while working in a fast-moving, matrixed organization The GMA Project Manager is responsible acting as the "Chief of Staff" for his/her team, leading efforts to achieve overall operational excellence across all activities & projects to accelerate business in a compliant & efficient manner. The GMA Project Manager further contributes to accelerating & optimizing the business via the following responsibilities/activities: Budget management & oversight of contract-to-purchase order (PO) process Facilitating key meetings (internal GMA, cross-functional, cross-regional, vendor meetings, etc.) Tracking of activities in terms of timing, anticipated risk, and mitigation of issues/conflict resolutions Leading / contributing to process improvement initiatives Encouraging overall operational excellence across all activities & projects Escalating issues in a timely manner Ensuring streamlined & efficient communication Responsibilities: GMAT/Function Support In close collaboration with the Team Lead (GMAT or Function), establish a strategic plan for monitoring the activities per the Business Plan & priorities. Support Team Lead to manage GMA project/activities, including ensuring that the GMAT/Function team delivers projects/activities successfully and on a timely manner as per annual plan & objectives. Establish milestones and metrics, in collaboration with GMAT/Function team, and develop a detailed project plan in order to track progress and measure impact of the activity. Generates critical path analyses and supports scenario planning for each GMAT/Function, in order to assess if objectives are met, exceeded, or not met. Have a strong understanding of activities, associated budget, and key contributing factors in order to anticipate potential risks and establish plan to mitigate, as appropriate. Lead and facilitate regular internal GMA & cross-functional/cross-regional team meetings; ensure agendas and team priorities are clear, meetings minutes are distributed, action items are completed. Lead the budget planning and tracking process for GMAT/Function team; work with GMAT/Function Leads to provide consolidated budget/LE updates (across all activities and regions) in a timely manner with appropriate rationale. Support GMAT/Function lead with annual Business Planning process & associated documents, including proactive engagement with internal and external stakeholders to manage plan development. Support GMAT/Function/Franchise Head in prioritization and planning of resources and develop rationale for annual resource planning. Lead issue resolution meetings. Lead risk identification, prioritization and mitigation planning processes across the Franchise. Manage the agendas for GMAT/Function meetings, the conduct of the GMAT/Function meetings, and the drafting of GMAT/Function meeting minutes. Ensure full documentation of meeting discussions, decisions and action items. Track & ensure completion of agreed action items. Ensure appropriate archiving of project documentation. Develop a monthly report that provides an overview of progress on all key activities, potential risks and mitigation actions. Generate and maintains strategic integrated GMA Franchise project plans, project timelines, high quality risk management plans, and communication plans, as needed. Liaise with DS Corporate Finance, Legal, and Procurement teams, as necessary, to ensure activities are executed efficiently and in compliance with company policies and procedures. Operational Excellence Support Collaborate with Head, Project Management & Operational Excellence to further strengthen operational excellence from a GMA-wide organization perspective. Disseminate key leadership communications throughout GMAT/Functional teams and lead issue escalation efforts when required. Identify gaps in Global Medical Affairs processes and functional procedures that (potentially) impact program delivery and escalate appropriately to Head, Project Management & Operational Excellence. Collaborate with Head, Project Management & Operational Excellence and GMAT/Functional Leads for formal presentations/communications to GMA Head and Senior management. Support Head, Project Management & Operational Excellence with monthly and annual updates to Senior leadership. Integrate operational excellence best practices into regular team meetings and communications to enhance overall capabilities. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Bachelor's degree with relevant professional experience or equivalent; advanced degree desirable. PMP or similar professional project management certification is a plus Minimum 7 year experience in pharma industry of which 5 years PM experience. Strong project management experience. PMP, Six Sigma or similar professional project management certification is a plus Demonstrated leadership skills, especially in areas of communication and change management Meticulous attention to detail in all aspects of work and expert organization skills Proven ability to drive decision making process, including ability to challenge teams and achieve excellence Ability to thrive in a fast-paced environment Self-starter, results-oriented Strong change management skills and engagement to enable continuous improvement Strong communication skills and ability to adapt according to different levels of management Ability to negotiate and align across franchise Demonstrated ability to collaborate effectively with key stakeholders Strong Microsoft Excel & PowerPoint skills required, SAP experience a plus Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Director, GMA Oncology, Project Management City Basking Ridge Functional Area Global Medical Affairs Oncology State New Jersey