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The Alliance Development and Stakeholder Strategy Head will serve as an integral member of the Regeneron Public Policy & Government Affairs team. This person will be responsible for the creation and execution of an integrated advocacy strategy and will be responsible for driving strategic and operational excellence for Regeneron's Public Policy & Government Affairs (PP&GA) partnered activities, representing the organization and department in various forums, and supporting direct partner interactions in Regeneron's highest priority alliance/partnered activities. This role will collaborate with both internal and external stakeholders including patient, provider, and business organizations to advance Regeneron's policy priorities. You will also participate in the coalition development activities associated with industry partnerships and will work in an open and mutually beneficial way to optimize Regeneron's development of novel, life-transforming therapies and ensuring patients have affordable access to such critical medicines. In this role a typical day may include: Develop strategic priorities, federal and state policy issues consistent with Regeneron's policy and business priorities, objectives, and mission. Develop a longer-term approach to identifying and engaging select patient groups/third party groups to partner in the advancement of federal and state policy goals. Facilitate the engagement of patient groups/third party organizations in Congressional and state legislative briefings, roundtables and hearings that enable progress against policy goals. Partner with internal stakeholders to ensure appropriate engagement with key patient groups/third parties to advance organizational business goals. Develop a Regeneron "stakeholder development plan," including identifying opportunities to engage patient groups/third parties with which Regeneron has not traditionally collaborated, and to support, expand or refocus existing participation efforts. Lead and generate communication to/from key third party organizations on appropriate key Regeneron regulatory and legislative issues. Acting as the primary point of contact for partner organizations, facilitating effective communication and collaboration. Plan and manage the operational aspects of the stakeholder relations, including appropriate communications, coordination of activities and solving business problems. Represent the Regeneron PP&GA team at key stakeholder meetings and engage with key external partners at meetings to identify opportunities for collaboration to advance common policy priorities. Collaborate with internal cross-functional team to execute on the strategic and tactical plan and identify opportunities for engagement with external partners. Manage product and therapeutic area policy issues, represent the PP&GA function on internal teams (e.g., brand teams), and provide strategic counsel to functional leaders, brand teams and government affairs to ensure effective alignment with corporate policy positions. This role may be for you if you possess: Proven ability to build trust and establish shared patient access goals between Regeneron and patient organizations/third party groups across a broad spectrum of therapeutic areas including ophthalmology, immunology, oncology, among others. High level of aptitude in developing strategic priorities, addressing federal and state policy issues consistent with Regeneron's policy and business priorities, objectives, and mission. Excellent communication, strategic thinking skills and skilled at working effectively in strategy teams. A clear reputation as a trusted partner who exemplifies integrity and ethical conduct. Strong strategic thinking skills and acute political sensitivity. Keen attention to detail and strong written and oral communication skills. Dynamic professional style and the ability to engage others and inspire confidence. Ability to develop and drive outcomes to advance company performance metrics. Ability to work independently as well as with a team and be able to produce timely, high-quality work with limited supervision. To be considered for this role, you must have a bachelor's degree; graduate degree in public policy, healthcare policy or law, or another related field is highly preferred with a minimum of 8+ years relevant experience. Excellent verbal and written communication skills and presentation skills to convey complex and changing legislation, regulations, and their impact to internal and external stakeholders. Strong strategy and execution skills with a track record of working with key thought leaders and diverse stakeholders. The ability to travel to relevant meetings/conferences, up to 50-60% of the time primarily within the U.S. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Salary Range (annually) $176,900.00 - $294,800.00

Position Summary The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies. This position is hybrid, based in Santa Monica, CA, and reports to the Executive Director, CMC Regulatory Affairs. Responsibilities Interpret global regulations and guidance to identify risks and provide input for guidance to cross-functional product teams. Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g., CMC component(s) of IND/IMPD/BLA/Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage regulatory dossiers throughout the product development lifecycle. Lead complex programs. Provide review and compilation to ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy. Represent CMC regulatory affairs on product teams and in health authority interactions. Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises. Support the development and maintenance of regulatory templates, best practices, and procedures. Supervisory Responsibilities Support hiring, leading workflow, and development of staff. Build and lead high-functioning teams. Education and Experience MA/MS degree in life sciences required, advanced degree preferred (PhD, PharmD). Experience of 10+ years with BS/BA; 8+ years with MS/MA or MBA; 6+ years with PhD. Prior experience in cell/gene therapy. In-depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies. Experience in IND, IMPD, BLA, MAA filings. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

JOB SUMMARY Reporting to the EVP, Chief Clinical Operations Officer and the senior-most physician of the DFW West Region, the Regional SVP Chief Medical Officer (CMO) is responsible for planning, overseeing, and directing strategic medical affairs within the region, including hospitals, clinics, ambulatory care facilities and joint ventures, This includes patient care operations, patient quality, patient safety joint ventures, physician networks, and medical credentialing functions. In partnership with regional President collaborate on strategic matters with other regional and system leaders to develop long-range and operational strategies to meet the needs of customers of BSWH. The CPE consults with BSWH presidents, senior executives, medical staff, and clinical staff on medical issues and operational problems affecting patient care and is responsible for enhancing the image and delivering healthcare value to BSWH stakeholders, patients, and communities served. The SVP, CMO - DFW West Region has direct leadership of Baylor Scott & White All Saints Medical Center - Fort Worth with additional oversight of Baylor Scott & White Medical Center - Irving and Baylor Scott & White Medical Center - Grapevine. A region Senior Vice President (SVP) sets policy and objectives within a major business unit or region/entity. Acts as a business expert requiring accomplished knowledge in many aspects of the work area, industry, and environment. Participates in broader strategy development with senior leadership. Accountable for implementation of strategy. Decisions involve differing situations over a multi-year time horizon of at least three to five years. Typically interacts with system "Chief" leadership level. Oversees multiple levels of subordinate entity/region vice presidents, directors, and/or managers covering varied disciplines and skill levels. Has primary accountability for business unit financial management, talent management, and input on major resource decisions. Translates and cascades corporate strategies and objectives to subordinate positions. Leads and monitors business performance. ESSENTIAL FUNCTIONS - Serves as Regional SVP Chief Medical Officer (CMO)and top physician executive for their designated region; serves as a dyad partner with the Regional President. - Serves as part of the region's senior leadership team, interacting with the regional President and other regional leaders, providing regular communication updates regarding medical/clinical operational performance. - Establishes region-wide clinical strategies, policies, programs and initiatives for medical leadership to ensure efficient and effective clinical operations that enable the highest quality of care, safety and patient satisfaction. - Oversees and ensures regulatory compliance of medical staff with joint commission requirements, HIPAA, CMS rules and regulations, and licensure requirements. Ensures that the medical staff practices are compliant with all applicable legal, regulatory, and accreditation requirements. - Evaluates new developments in medical care and recommends new practices and procedures. - Leads the development of new policies, procedures, protocols, and standards related to physician practice. Implements, educates, and enforces medical staff bylaws and rules of the medical staff. - Partners and facilitates physician relations, recruitment, credentialing, and peer review activities. - Evaluates and implements quality and efficiency improvement activities and effectively communicates changes. - Oversees, develops, and implements medical programs and initiatives to improve the medical service delivery and quality of patient care within the region in alignment with BSWH's business goals. - Reviews patient and referring physician satisfaction surveys and assists in developing responses and change management to improve satisfaction scores. - Reduces patient diversion to other facilities through proactive management of bed flow, physician education and optimizing inpatient and outpatient access. - May guide and participate in the educational activities of medical staff including medical students and residents. KEY SUCCESS FACTORS - Doctor of Medicine (MD) or Doctor Osteopathic Medicine (DO) required. MBA or MHA preferred. - 7+ years of experience as a physician in clinical practice. - 3+ years of leadership experience preferred. - Proven experience aligning and leading the medical operations of a region or hospital within a healthcare system, preferably including program growth, practice acquisition, technology implementation, process improvement, and regulatory compliance. - Current and unrestricted license to practice medicine in the state of Texas. - Current certification by the appropriate certifying board. - Informative and persuasive presentation skills. - Solid clinician skills with understanding of risk management, managed care contracting, national benchmarking, and related quality metrics. MINIMUM REQUIREMENTS - Doctor of Medicine (MD or DO) - 7 years of experience

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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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. Summary With the Head of Government Affairs & Public Policy, this position will help lead Daiichi Sankyo's engagement across the United States to ensure patient access to our current portfolio and robust pipeline of medicines. This position will identify key issues in state legislation and regulation that could impact the company and patients. Informed by collaboration across functions, lead efforts to develop strategies to mitigate risks and harms while also proactively pursuing opportunities to bring our medicines to the patients who need them. Responsibilities - With the Head of Government Affairs and Public Policy, develop, lead and prioritize Daiichi Sankyo's legislative and regulatory engagement and strategy in the states and D.C., with a focus on key states and priority issues. Monitor and analyze state legislative and regulatory developments with potential impact Daiichi Sankyo's business and patient access to medicines. Identify risks and opportunities and develop strategy for engagement on Daiichi Sankyo's priority issues, collaborating with internal subject matter experts and aligning with leadership and Government Affairs Public Policy team. - Build and maintain relationships with key governors, state and local elected officials, and with external stakeholders at the state level. - Educate internal stakeholders and business leaders on emerging trends and existing risks and opportunities at the state level, while also seeking their input and feedback to inform state government affairs strategy and engagement. Contributes to internal and external advocacy and educational materials and provides support to leadership in external engagement. - Engage with trade associations (PhRMA, HINJ) on priority state issues, tracking state developments and working to shape industry's broader positioning to reflect Daiichi Sankyo's business needs. Supports PhRMA Board Member, as needed. - Manage state government consultants, and contract lobbyists as required, to ensure their work advances Daiichi Sankyo's priorities and brings sustained value to the organization. - Support Government Affairs Public Policy team in other areas, as needed, to move Daiichi Sankyo goals forward. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree required - Master's Degree preferred - JD preferred Experience Qualifications - 10 or More Years Combined experience working in government, government affairs, trade association, or pharmaceutical company required - Experience working on state legislative and regulatory issues required - Knowledge of state legislative and rulemaking processes; experience researching and analyzing complex public policy issues required - Expertise in oncology and with physician-administered medicines preferred - Experience building state government affairs function preferred Travel Ability to travel up to 20% Travel for business meetings as necessary; optimal candidate is located in Washington DC or Basking Ridge NJ areas; other parts of the U.S. can be considered as well. 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.

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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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. SUMMARY Develop the strategic direction for Global Research QA including activities under GLP,GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting Oncology and / or specialty medicines are being discussed. Develop a QA structure that could support GLP/non-GLP/ GCLP Research activities at the global level. Support through open and effective communication and business partnering the cross-functional implementation of the Vision and Mission of Global QA. Drive a Culture of solution oriented and evidence-based mind-set with openness for innovative ways of working with new technologies/ Implementing strategic and tactical plans to drive sustainable improvements. Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health authorities globally. Provide QA oversight of GLP/GCLP activities of Daiichi Sankyo, contract research organization/ vendors ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes are in place to enhance GLP/GCLP activities being executed at DS cross-functional teams (i.e , Research, Translational Oncology, GDO etc.,). Serve as a QA representation at key governance meetings whereby GCLP/GLP activities are being discussed (Regulatory affairs, Research unit LT, GRDC etc.,) Effectively interacts with broad range of colleagues in order to establish a globally aligned GCLP/GLP strategy across DS teams. Establishes and / or develops operational resource strategy to determine the extent of resources needed to deliver on GLP/GCLP commitments that are pivotal to early phase submissions. Collaborate with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively identifies compliance risks impacting research unit across DSG, and assures that mitigation strategies are in place. Responsible to engage directly with Health authorities such as FDA, EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. Responsibilities Leads nonclinical QA function to implement a quality system in accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices. Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight. Manage and/ or guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions (IMPD/IND) Responsible to design the audit framework globally for Research area, specifically GLP/GCLP studies. Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with regulations, standards and guidance such as ISO, CLIA, etc. Ensures that laboratories and / or vendors that are responsible for biomarkers, special analytical methods, assays etc., are assessed and that any nonconformance are appropriately mitigated. Ensure approved metrics are in place to monitor and provide proper QA oversight of research area, in close collaboration with stakeholders. Ensure metrics for reporting purposes are readily available for presenting at senior leadership meetings. Ensure and lead the establishment of the Quality Systems for the Research Quality area, and that all components of QMS are in place for adequate quality review and oversight. Develop and implement the Research Quality QRB with key partners and collaborators. Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities and regulators. Ensure a process is in place for routine review of regulatory documents such as IB, protocol, CSRs, IND and NDA Ensure GLP regulated activities for computer systems are in place and in some areas ensure that an internal QA assessment of research notebooks for compliance oversight is in place and all regulations being adhered to. Ensure that Clinical Development activities (i.e , protocols) are aligned with GLP/GCLP, FDA, ICH, EMA, PMDA regulations/ standards and guidance. Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with stakeholders to ensure a compliant ready state of operation. Ensure that CRO/ Vendor quality events/ incidences are adequately reviewed and CAPAs followed up and / or closed as appropriate. Serve as a key contributor on several leadership teams and governance committees to provide quality overview, metrics, trends, impacting the Business portfolio: a. Research Committee/ CDx/Translational Oncology/Precision Medicine/ RD-DLTb. External Alliance Committee. b. Quality leadership team c. Develop/ chair or co-lead quality council as necessary. Ensure the vision is in place to build the talent pipeline(recruitment) and ensure succession plans are in place and promote the values of integrity, accountability, transparency necessary to drive change in fast pace, changing organization. Allocates and manages financial and human resources within the function. Accountable for performance, progress and success of the team by ensuring that objectives are clear, in place and that teams are managed to drive results. QUALIFICATIONS Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Must have a Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or Medicines PhD or other post graduate degree strongly preferred Experience Qualifications Must have at least 10+ years of professional expertise within GxP regulated activities, and QA leadership positions; broad understanding of global expectations of Health Authorities in the GxP area; profound understanding of the science of product development. Must have experience within a global pharmaceutical company with expertise in: oncology, biologics or vaccines. Must have proven expertise within Quality Assurance Research to support Global Research QA including activities under GLP, GCLP. Translational research Oncology, precision medicine and other research relevant duties under the RDPV QA function Must have proven ability to lead and influence others within a global/matrix environment in the pharmaceutical industry required Must have proven people management experience including experience in a matrix, global environment required Must have strong communications skills, written and oral. Travel Must have the ability to travel up to 20%. Domestic and International travel 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.

DaCut is a top player in the cannabis industry, dedicated to providing premium products and exceptional service. We are growing our retail footprint and looking for a seasoned and talented Director of Cannabis Retail Operations to become a key member of our vibrant team. Job Description As the Director of Retail Operations specializing in cannabis dispensaries, you will be a seasoned leader with extensive experience in managing high-volume retail operations, particularly within the framework of Michigan cannabis laws. Ideally, you'll understand the importance of fostering a people-centric culture, managing financial aspects effectively, driving continuous improvement, ensuring alignment with brand standards, and collaborating cross-functionally to support retail operations. Your role encompasses overseeing sales, inventory management, METRC compliance, SOP development, training, and leadership development for our cannabis dispensary locations. Leveraging your comprehensive understanding of Michigan cannabis regulations and experience in high-volume inventory management, you will play a key role in shaping the success of our retail operations. Additionally, your expertise in rotating aging products and creating deals, promos, and marketing content to push old product will be instrumental in optimizing inventory turnover and maximizing revenue. Reporting directly to the CEO, you will serve as a vital link between retail operations and executive leadership. Key Responsibilities Cannabis Retail Strategy: Develop and execute a retail strategy tailored to the Michigan cannabis market, with a focus on high-volume sales environments. Stay abreast of changes in Michigan cannabis laws and adjust operational strategies accordingly. Sales Optimization: Implement and refine sales strategies to achieve revenue targets in high-volume retail settings. Analyze sales data to identify opportunities for growth and areas for improvement. Provide guidance and training to dispensary staff to enhance sales performance in fast-paced environments. Inventory Management: Oversee and optimize inventory management processes to meet the demands of high-volume sales while ensuring compliance with Michigan cannabis laws. Develop and implement strategies for rotating aging products to minimize waste and maximize product freshness. Collaborate with suppliers to manage product availability and maintain appropriate stock levels to meet customer demand. Implement best practices for inventory tracking and reconciliation in a fast-paced environment. METRC Compliance: Ensure strict adherence to METRC (Marijuana Enforcement Tracking Reporting Compliance) regulations and reporting requirements, even in high-volume retail settings. Implement and maintain processes to track and report cannabis product movements accurately, efficiently handling large transaction volumes. Conduct regular audits to ensure compliance with METRC guidelines while managing high transaction volumes. Standard Operating Procedure (SOP) Development: Develop and document standard operating procedures for all dispensary operations, ensuring compliance with regulatory requirements and best practices in high-volume environments. Regularly review and update SOPs to reflect changes in regulations or operational processes, optimizing efficiency and compliance in fast-paced settings. Training and Leadership Development: Develop and implement comprehensive training programs for dispensary staff, focusing on product knowledge, customer service, compliance, and efficient operations in high-volume environments. Provide leadership and mentorship to foster a positive and efficient team culture capable of thriving in high-volume retail settings. Michigan Cannabis Laws and Regulatory Affairs: Maintain an up-to-date understanding of Michigan cannabis laws and regulatory requirements, ensuring compliance in high-volume retail operations. Ensure dispensary operations align with all applicable legal and regulatory standards, even in fast-paced environments. Work closely with legal counsel to address any compliance concerns arising from high transaction volumes. Customer Experience Enhancement: Collaborate with marketing teams to enhance the overall customer experience through promotions, events, and loyalty programs tailored to high-volume retail environments. Monitor customer feedback and adjust strategies to continuously improve customer satisfaction amidst high transaction volumes. Create deals, promos, and marketing content to push old products, maximizing revenue and minimizing inventory turnover. Financial Management: Develop and manage budgets for retail operations, considering the unique financial challenges and opportunities presented by high-volume sales environments. Analyze financial reports to identify cost-saving opportunities and revenue enhancement strategies specific to high-volume retail settings. Technology Integration: Identify and implement technology solutions specific to cannabis retail operations, including POS systems and compliance software optimized for high-volume transactions. Stay informed about industry-specific technologies and tools capable of supporting efficient operations in high-volume retail environments. Travel Requirement: Must be able to travel to all store locations and open new stores as needed to oversee operations and ensure consistent implementation of standards. Qualifications Bachelor's degree in Business Administration, Retail Management, or a related field; Master's degree preferred. 5+ years of experience in retail operations, with a focus on cannabis dispensaries and high-volume retail environments. Extensive knowledge of Michigan cannabis laws and regulatory requirements. Proven leadership skills and experience managing teams in fast-paced, high-volume settings. Strong understanding of sales strategies, inventory management, METRC compliance, SOP development, and training. Excellent communication and interpersonal skills. Adaptability to a dynamic and evolving regulatory environment.

Summary: A global health care company, dedicated to improving people's lives through innovative solutions specialised in pharmaceuticals, medical devices, and over-the-counter products is looking to bring on an Associate Director of Regulatory Affairs Ad/Promo to join their team! The Ad/Promo team is rapidly growing, and they are looking for someone to come in and provide their expertise, based out of their New Jersey office. This role will give you an amazing opportunity to contribute to the companies mission to enrich lives by delivering better health outcomes. The Associate Director will be responsible for Reviewing Ad/Promo materials, new campaigns, and launch strategies for assigned products to ensure regulatory compliance. Ensure timely and accurate evaluation to meet deadlines and requirements Developing and implement regulatory strategies and solutions to ensure all ad/promo material comply with regulatory requirements and company policies Monitoring FDA activities, including enforcement actions and guidance documents, to assess their impact on company products Ensuring that promotional package inserts and important safety information are updated as necessary The Associate Director should have the following qualifications: Bachelor's degree is required in Life Science or related field; Advanced degree (MS, MD, PhD, PharmD) preferred Minimum of 8 years of pharmaceutical experience; 4+ years of prescription product ad/promo review experience Working knowledge of the Rx product NDA and labeling processes Course training in ad/promo review Strong interpersonal skills, ability to work on a team, and communication skills Benefits: Medical, Dental and Vision insurance 401(k) matching Tuition reimbursement Commuter benefits

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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. Summary: This position (GRL Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other regions. This position ensures alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives. This position serves as the primary contact for interactions with cross-functional team members and leads complex discussions at the project team level as well as at governance meetings. This position mentors/instructs and provides guidance to internal and external direct/indirect reports. This position also interacts with other therapeutic area leaders and joint Alliance partners. Responsibilities: Lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects. Gain endorsement from the Global Project Team (GPT) for these plans, ensuring appropriateness throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo governance processes, and on Joint Alliances. Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area strategy, corporate goals, and regional regulatory requirements/precedence. Represent Daiichi Sankyo's regulatory group in internal and external development project meetings. Provide guidance to peers and cross-functional team members regarding strategic regulatory issues. Develop timeline and strategic input with feedback from the regional strategists in terms of Health Authority meetings globally. Provide leadership and set direction, acting as a key decision-maker and/or arbitrator on global projects. Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within the company as needed. In collaboration with Regulatory Intelligence and Policy team members, review and interpret regulatory guidelines, regulatory precedence and competitive landscape with respect to impact on development programs. Ability to serve and participate on internal and external panels related to Health Authority initiatives. Review of clinical study protocols, health authority dossiers and briefing books. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree required Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline preferred Experience Qualifications 10 or More Years Experience in the pharmaceutical industry 7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in Oncology Managerial experience Experience with ex-US regulatory authorities Travel - Ability to travel up to 20% In-house office position that may require occasional travel (global). 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.

Associate Director, Regulatory Affairs Advertising and Promotion At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and input on Gilead's commercial and corporate communications, and plays a critical role ensuring that these activities are compliant with governing laws, regulations, and Gilead policies and procedures, while enabling the business to compliantly meet its goals and objectives. This group also represents Gilead's commercial activities to U.S. regulatory agencies. You will manage the commercial regulatory strategy and execution of such for one or more high-volume and/or otherwise complex brands or therapeutic areas. You may manage, oversee, and review the work of one or more direct reports. You will represent the commercial regulatory perspective at and chair high-volume Promotional Review Committee (PRC) meetings for complex brands. You may lead local cross-functional process improvements or other special projects. You will provide strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to promotional materials with regulatory agencies. You will communicate relevant updates or changes to cross-functional leaders and teams. EXAMPLE RESPONSIBILITIES: Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials. Serves as PRC Chair for one or more high-volume and complex brands or therapeutic areas. Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Serves as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products, with managerial oversight, as appropriate. May lead local cross-functional process improvements or other special projects. May initiate and/or contribute to global process improvements. Provides regulatory guidance on new marketing concepts, messaging, and campaigns. Represents RA Ad/Promo at Regulatory Project Team meetings. Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. Mentors RA Ad/Promo and cross-functional team members as needed. May have one or more direct reports. Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements. REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. Education & Experience PharmD/PhD 4+ years' relevant experience. MA/MS/MBA with 8+years' relevant experience. BA/BS with 10+ years' relevant experience. For external candidates, 4+ years' experience in regulatory review of promotions for prescription drugs or other biologic products. Significant experience leading development and execution of regulatory submissions of promotional materials for marketed prescription drug or biologic products. Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products. Experience chairing/leading promotional review committees or other relevant regulatory governance committees. Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus. Line management (direct reports) experience is a plus. Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities. Experience working with external contractors supporting the work of regulatory affairs is a plus. Experience authoring and/or implementing processes. Significant experience participating in cross-functional projects and teams. Knowledge & Other Requirements Demonstrates in-depth knowledge of current trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products or projects. Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications. In-depth knowledge of promotional regulations and guidance for prescription drug and biologic products, including industry best practices and standards. Working knowledge of relevant regulatory or related systems is preferred. Demonstrates ability to rapidly learn new therapeutic areas. Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives. Strong interpersonal skills and understanding of team dynamics. Strong communication and organizational skills. Strong negotiation and conflict resolution skills. When needed, ability to travel.

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Senior Manager/Associate Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine. Responsibilities Developing and leading global regulatory strategies to support business objectives Leading and assisting with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc. Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale Developing and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controls Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal records Work closely with business leadership to ensure regulatory strategy aligns with commercial goals Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently What your background might look like Experience with complex medical devices, such as some combination of: Software and artificial intelligence based devices Clinical decision support software Medical imaging Oncology Cardiology Experience with: Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, Investigational Device Exemption (IDE) requirements Ex-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDR Software validation and risk management Cybersecurity in medical devices Machine learning validation requirements Lifecycle management of medical devices/IVDs Changes to medical devices or IVDs, including those that trigger reporting or regulatory submissions Relevant sections of 21 CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards Strong communication, presentation and interpersonal skills Experience leading cross-functional teams of subject matter experts Experience working in a startup-like environment Experience interacting with regulators Ability to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areas Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs Excellent attention to detail Strong project management skills and the ability to execute on project plans in a fast-paced environment Scientific background Bachelor of Science in a scientific discipline (biology, chemistry, engineering), MS, MSE or PhD preferred. Minimum of 7+ years of experience in Regulatory Affairs related to medical devices Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans

Director, Development Information Systems Boston, MA, USA Req Wednesday, August 14, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. About the Role: We are seeking a Director, Development Information Systems, to join our team. This role will be the IT business partner for most of the functions reporting to the Chief Medical Officer, including Clinical Development, Clinical Operations, Translational Research, Biostatistics & Programming, Pharmacovigilance, and Regulatory Affairs. The Director will partner with those groups to develop and execute against a functional technology roadmap, support existing enterprise applications such as the Argus PV system, and ensure effective and secure data exchange with external service providers. In addition to designing, building, and supporting systems, the Director will facilitate the design and adoption of effective data governance and lifecycle management processes, including the design and implementation of new technology to support these practices as needed. The Director will act as the primary point of contact for the designated user groups on all topics related to IT and will partner with colleagues in IT to resolve issues and deliver solutions. The Director will also ensure that IT-sponsored initiatives and standards are tailored to meet the needs of colleagues in the Development functions and are successfully adopted by those groups. The Director will play a central role in maturing the company's approach to building and maintaining validated information systems, including adoption of a new System Development Lifecycle (SDLC) and related practices. The IT group at Xenon is expanding rapidly to support the company's growth plans. The Director will begin as an individual contributor in a hands-on role, with the expectation that their team will expand over time as new systems are implemented and as the IT operating model evolves. During this period of rapid growth and evolution, the Director will be assigned additional responsibilities (beyond the core responsibilities described above) based on company needs, the individual's experience and expertise, and the availability of resources within IT. This position reports to the Senior Vice President, Information Systems and will be located in the Boston, MA, USA. This role is a hybrid position. The level of the position will be commensurate with the candidate's education and industry experience. RESPONSIBILITIES: Act as the IT owner for all relevant functional systems and collaborate with functional system owners and colleagues in IT to evolve the support model based on the needs of the users and the overall IT strategy. Partner with key stakeholders in the Development functions to develop and execute against a functional technology roadmap encompassing current and future systems to address existing pain points, maximize the usage and value of existing systems, and develop new capabilities as needed. Serve as the primary point of contact between the Development functions and IT to resolve issues, align on processes and standards, and ensure awareness and alignment on key initiatives (function- or IT-sponsored). Ensure that IT standards and processes are tailored to meet the unique needs and capabilities of the Development functions. Actively collaborate with other IT business partners to manage common or cross-functional requirements and project dependencies, and to ensure an effective enterprise approach to system planning and design. Facilitate effective IT planning, governance, and project delivery as these processes evolve. Collaborate with the head of Data Architecture and Engineering to ensure effective and secure data exchange with external service providers, and to facilitate the design and adoption of effective data governance and lifecycle management processes and tools to control data lineage. Design, develop, and document effective data flows and integrations among systems to enable efficient processes and workflows (including automation) and effective reporting and analytics. Collaborate with functional stakeholders and with the Quality organization to ensure relevant systems are built and maintained in compliance with regulatory requirements and internal policies and procedures. Manage vendor relationships (e.g. software and service providers) in the context of both project delivery and ongoing operations to maximize value to Xenon. As a member of the IT Leadership Team, contribute to the development and execution of the strategy to evolve the overall IT operating model, including new structure, processes, and ways of working. Take on additional responsibilities as the IT group grows and evolves based on company needs, relevant experience and expertise, and availability of resources within IT. Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any. QUALIFICATIONS: Minimum undergraduate degree in Computer Science, Informatics, or related discipline. At least 10 years of progressive information technology / informatics experience in a commercial life sciences organization, including people management. Experience working in a regulated environment including working knowledge of system validation requirements and frameworks. Domain knowledge of the work performed with the Development functions, including the ability to effectively collaborate with functional stakeholders. Demonstrated ability to set direction and lead while simultaneously performing hands-on work. Proven ability to diagnose and solve problems, and to identify opportunities to more effectively leverage technology and data to drive agility, efficiency, insights, and compliance. Broad knowledge base of cloud technology offerings as they relate to life sciences. Excellent written and verbal communication skills with the ability to explain highly technical information in a concise and effective manner to an audience of varying technical aptitude. Strong interpersonal skills that support quickly building rapport with IT colleagues, functional stakeholders, and external vendors; ability to manage competing interests in a professional, collaborative and solution-driven manner. A problem-solving mindset - i.e. data-driven focus on understanding root causes and developing robust solutions. Ability to work flexibly in a fast-paced environment with a strong work ethic and positive attitude. Demonstrated ability to lead continuous improvements in IT delivery processes and practices. The base salary range for this role is $199,800 to $222,800 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees. US positions only:Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here . To apply for this position, click Apply Now to complete the application . click apply for full job details

Job Title: Associate Director - Regulatory Affairs Location: San Diego, CA / Hybrid / Remote Position type: Full time FLSA: Exempt Department: Regulatory Affairs Strive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people's lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit and engage with us on LinkedIn and Twitter . The Opportunity The Associate Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently managing life cycle plans along with regulatory submissions and approvals. The position is responsible for oversight and execution of global regulatory activities, for product registrations and applications (INDs, BLAs, CTAs, MAAs, Amendments, PIPs, Designations, etc.) and regulatory compliance. The position is expected to capably interface with internal senior leadership and external consultants/vendors as well as with domestic and international Regulatory Authorities. The optimal candidate for the position will be passionate about developing novel therapeutics for people in need. What You Will Contribute Establish regulatory strategies and plans by collaborating and coordinating with relevant development team members - represent the regulatory function as a core development team contributor Communicate creative ideas and manage regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans and timelines Develop and communicate regulatory strategies and plans that align with project objectives and overall business strategy Direct and lead execution plans for regulatory submissions Proactively identify potential program and/or submission risks and implement appropriate regulatory mitigation strategies to support successful outcomes Lead the coordination and authoring of regulatory meeting packages and contribute to/lead Regulatory Authority meetings Assist in the management and oversight of regulatory activities relating to clinical trials and other operational aspects of clinical trial preparation Determine and communicate documentation requirements for submissions in a transparent and timely way to enable efficient regulatory submissions Prepare/author documents in collaboration with CRO/regulatory vendors for submission of clinical trial applications in US, and ex-US countries Review submission components to ensure compliance with health authority expectations, including associated guidelines and regulations. Provide oversight and management of external regulatory vendors and regulatory resources Assist in the management, oversight, authoring and coordination of Request for Information (RFI's) received from Health authorities for clinical trials and IND's Assist with mentorship of the regulatory team and use experience and expertise to provide guidance to the wider organization Advise on labeling, promotional review and other post marketing/commercial regulatory activities Assure compliance with regulatory reporting requirements Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs or other departments. Represent the Company's interests with national government agencies, industry associations and/or other organizations with legislation, regulations and/or guidelines that impact the business Perform other duties as required What We Seek Bachelor's Degree required; Advanced Degree a plus Bachelor's degree Life/Health Sciences; Master's degree and/or Ph.D. a plus Minimum of 7 years of experience in pharmaceutical / biotech with a minimum of 4+ years in clinical Regulatory Affairs Comprehensive knowledge of current US and ex-US regulations and guidelines, in-depth experience leading Regulatory in Global environments, including development of strategies and assessment of risks related to regulatory and development activities as well as experience in leading Regulatory Authority interactions/meetings. Experience in authoring briefing books and submission packages for Regulatory Authority meetings Experience developing products, including INDs, CTAs, NDAs/BLAs, MAAs, expedited approval pathways, etc. Proven ability to establish strategy and to translate it into an effective, long term action plan Demonstrated success in effectively leading cross-functional teams Thorough understanding of the regulatory process from development through commercialization Strong project management skills Established track record with evidence of excellent problem-solving, collaboration, leadership, and communication skills Strong written and oral communication skills Able to grasp complex technical issues and make sound decisions based on data and information from various sources Ability to foster and promote internal collaboration What We Will Provide to You: The base salary range for this role is $170,000 - $187,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors. Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off. A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Turning Space into a Transportation Layer for Earth Who We Are: Eras of humanity can often be defined by a dominate transportation mode - horse drawn chariots, ocean going boats, or aircraft. These were spurred by a small group of people rigorously focused on building technology to achieve faster access to more of the world. We seek to usher in a new era of humanity defined by universal access to the whole globe free of borders and the presence of a routine way from space to Earth. To do this, we are building highly maneuverable re-entry vehicles that can loiter in orbit before precision landing back on Earth. Position Overview: We are seeking an experienced and proactive General Counsel to join our leadership team. This role will be pivotal in providing legal guidance and support across all aspects of our operations, ensuring compliance with laws and regulations, managing legal risks, and contributing to strategic decision-making. The ideal candidate will have a strong background in aerospace or related industries, along with expertise in corporate governance, contracts, intellectual property, and regulatory matters. Key Responsibilities: Serve as the principal legal advisor to the company's executives and board of directors. Provide guidance on legal matters related to corporate governance, regulatory compliance, and strategic transactions. Draft, review, and negotiate a wide range of contracts, including agreements with suppliers, customers, and partners. Manage and protect the company's intellectual property portfolio, including patents, trademarks, and trade secrets. Monitor and ensure compliance with applicable laws, regulations, and industry standards. Handle litigation and legal disputes, working with external counsel as necessary. Conduct legal research and analysis to support business initiatives and decision-making. Develop and implement policies and procedures to mitigate legal risks and ensure best practices. Required Qualifications: Juris Doctor (JD) degree from an accredited law school; active member of the Bar in good standing. 7+ years of experience practicing law, preferably with a focus on aerospace, defense, or technology sectors. Proven track record of providing strategic legal advice and counsel in a corporate environment. Strong negotiation skills and experience in drafting complex agreements. Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments. Ability to thrive in a fast-paced, entrepreneurial environment and manage multiple priorities. Our office headquarters is located in Torrance, CA. This position requires in office presence full time The California annual base salary for this role is currently $200,000-$300,000. Pay Grades are determined by role, level, location, and alignment with market data. Individual pay will be determined on a case-by-case basis and may vary based on the following considerations: interviews and an assessment of several factors that are unique to each candidate, job-related skills, relevant education and experience, certifications, abilities of the candidate and internal equity. To conform to U.S. Government space technology export regulations, including the International Traffic in Arms Regulations (ITAR) you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State. Learn more about the ITARhere . Inversion provides equal employment opportunities to all employees and applicants without regard to race, color, religion, age, sex, gender identity, sexual orientation, national origin, veteran status, or disability. Inversion collects and processes personal data in accordance with applicable data protection laws. If you are a US Job Applicant see the CCPA Privacy Policy Notice for further details. Apply for this job indicates a required field First Name Last Name Email Phone Resume/CV Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf LinkedIn Profile Website What are your base salary ($USD) expectations? Are you open to relocating to our corporate headquarters in Torrance, CA? Select Are you authorized to work in the United States without sponsorship? Select Were you referred to Inversion by a current employee? Select If you were referred, please provide the name of the employee. To conform to U.S. Government space technology export regulations, including the International Traffic in Arms Regulations (ITAR) you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State. 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People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? A disability is a condition that substantially limits one or more of your "major life activities." If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker . click apply for full job details

Senior Manager/Associate Director, Supply Chain Planning Boston, MA, USA Req Thursday, August 15, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team. What We Do: We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations. About the Role: We are seeking a Senior Manager/Associate Director, Supply Chain Planning to join our team. The Senior Manager/Associate Director, Supply Chain Planning will be responsible for supply chain planning for clinical supplies (clinical trial material) across a number of small molecule drug development programs in support of Xenon's clinical trials. The Senior Manager, Supply Chain Planning will additionally be responsible for developing and managing end-to-end supply chain plans for Xenon's products. The candidate will collaborate closely with the CMC and Supply Chain Management teams, as well as with key internal stakeholders such as Finance, Clinical Operations, Regulatory Affairs, and Quality Assurance. This position reports to the Senior Director, Supply Chain Systems and will be in Boston, MA, USA. This role is a hybrid position, requiring a minimum of 2 days per week in the office. The level of the position will be commensurate with the candidate's education and industry experience. RESPONSIBILITIES: Manage end-to-end Supply Chain Planning, including but not limited to: Demand, Supply, and Inventory Plans; Master Data, processes, and associated systems, and; Management of forecasting and CMO requirements in support of our Sales and Operations Planning (S&OP) processes. Manage Master Data, processes, and associated systems, including but not limited to: Managing the creation, implementation, and maintenance of master data management solutions that enable users to optimize system capabilities; Enrich master data elements and optimize the flow of data between users and stakeholders; Ensuring that data are accurate by conducting audits and identifying trends that may indicate problems with data quality, and; Designing and implementing data management policies and procedures to ensure organizational compliance with pertinent industry regulations. Lead and manage Supply Chain Planning projects that incorporate people, process and technology requirements as part of a cross-functional team. Prepare and present Key Performance Indicators (KPI) reports, perform root-cause analysis assessments, and implement continuous improvement actions, as needed. Produce regular performance reports based on KPI analysis. Collaborate with Management, the Supply Chain Management team and other internal teams, as needed. Lead the transformation of the Supply Chain Management department in-line with, or ahead of, the demands of our businesses. Develop the skills and capabilities of Supply Chain Management best practices, business sector knowledge and analytics across the team. Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any. Other duties as assigned. Some international travel may be required. QUALIFICATIONS: A university degree in health sciences, life sciences or physical sciences (or equivalent) with 7+ years' experience in the pharmaceutical/biotechnology industry. A minimum of 5 years' management level experience in a pharma or biotech environment. Job level commensurate with years of experience. Experience and deep knowledge of pharmaceutical Supply Chain Planning and Master Data as they pertain to people, process and technology needs. Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), International Conference on Harmonization (ICH) Guidelines and other relevant global pharmaceutical regulations, guidelines and directives. Experience with Master Data and ERP systems, as well as planning applications design, implementation, and user acceptance testing (UAT) is required. Proficiency with Microsoft applications, electronic data capture systems and inventory management systems. Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel. Excellent attention to detail and commitment to providing accurate, high-quality work. Good organizational skills and the ability to manage multiple competing priorities. Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team. The base salary range for this role is $143,500 to $200,000 USD ; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees. US positions only:Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here . To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

Become a genetic navigator. Our mission is to discover new genetic insights and translate them into new precision medicines. With an unparalleled commitment to changing the way people with severe diseases are treated, our team is at the forefront of accelerating our understanding of the genetic drivers of disease. We celebrate a diversity of perspectives and champion creative thinking to achieve our ambitious goals. Associate Director, Patient Advocacy and Community Engagement (hybrid or remote) At Maze Therapeutics, we're on a mission to make a difference in the lives of people affected by kidney disease. We're looking for an Associate Director of Patient Advocacy and Community Engagement to join our Clinical Development Team. In this role, you'll be at the heart of our efforts to connect with and support kidney disease patient communities. Initially, you will focus on our lead program for APOL1 kidney disease and over time expand your impact to other kidney disease indications. You'll collaborate closely with our cross-functional teams and collaborate with Corporate Communications and Legal, while building and nurturing strong relationships with patient communities across the US and globally. If you're passionate, driven, and ready to champion the voices of patients, this might be the perfect role for you. Your Impact: Develop and roll out patient advocacy strategies that help us make a real difference in the kidney disease space - locally, nationally, and globally. Serve as a bridge between Maze and the patient communities in support of our kidney disease development programs. Forge and maintain strong partnerships with patient advocacy groups, healthcare associates, and other key players while staying informed about industry trends and best practices in patient experience. Ensure the voices of patients and caregivers are front and center in everything we do, shaping a patient-centric approach in our clinical development efforts. Coordinate opportunities for patient speakers and organize company-wide activities that boost awareness and education around kidney disease. Provide input into annual budgeting process in support of patient advocacy goals. Navigate all your interactions with patient communities and advocacy groups with the highest ethical standards, keeping everything above board with GCP, regulatory guidelines, and industry norms. Drive initiatives to improve patient care and leave a lasting positive impact on the communities we serve. As an Associate Director, we also expect our leaders to demonstrate the following Leadership Competencies: Communication and Influence Communicates the reasoning behind decisions to appropriate stakeholders. Promotes open communication with internal and external stakeholders. Fosters healthy and respectful debate. Teamwork and Collaboration Creates opportunities for team members to connect with others outside of team. Manages conflict effectively between teams. Openly values thoughts, opinions, and contributions of employees. Execution and Results Exercises astute judgment to make decisions with only the necessary amount of data. Supports team members in creating their own resolutions to challenges and problems. Works with others to reinforce process compliance, what good looks like, and risk mitigation. Develop Others and Self Articulates what good looks like throughout Maze. Pursues development activities for continuous improvement of self and team. Skills and Qualifications: A bachelor's or graduate degree in nursing, pharmacy, social work, public policy, public health, or a related field is preferred. Minimum of 5 years of experience in patient advocacy and engagement, medical affairs, public health, and coalition building with a strong preference for experience in kidney disease patient advocacy. Experience working with underserved minority groups is a big plus. In-depth understanding of healthcare, pharma, and biotech industries; familiarity with the complexities of the drug development process, including FDA and EMA regulations and guidelines. Proven teamwork and collaboration skills, with ability to influence all levels of internal and external organizations. Demonstrated ability to foster buy-in and build consensus across diverse groups of people and individuals. Excellent interpersonal skills and heightened social awareness to navigate a diverse range of social interactions, both 1:1 and in group settings of varying sizes. A self-starter and able to work independently under tight timelines; solid business acumen, strong negotiation skills, and can prepare thoughtful, engaging, and concise presentations. Strong communication skills, both in writing and speaking; ability to deliver a compelling and impactful presentation. Travel and Flexibility: Up to 25%, with the possibility of more frequent travel as needed. Onsite, hybrid, or remote with ability to visit headquarters regularly. About Maze Therapeutics: Maze Therapeutics is a biopharmaceutical company that is harnessing the power of human genetics to transform the lives of patients, with a focus on genetically informed therapies for common diseases, such as chronic kidney disease, and seeks to focus expertise and resources towards underserved communities. Maze applies variant functionalization in tandem with advanced data science methods and a robust suite of research and development capabilities to advance a pipeline of novel precision medicines. Maze has developed the Maze Compass Platform, a proprietary, purpose-built platform to understand and integrate the critical step of variant functionalization into each stage of drug development. Utilizing the Maze Compass Platform, Maze is building a broad portfolio of wholly owned and partnered programs. Its two lead programs are focused in Chronic Kidney Disease (CKD), a condition that impacts an estimated 37m individuals. The first program in CKD addresses a genetic subset of the common disease that has a disproportionate impact on the Black Community. Maze is based in South San Francisco. Our People: Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values: Further Together - Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed - We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True - Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $171,000 - $210,000. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy.

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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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 primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics. Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act as CDx representative to GPT for early-stage programs. Contributes to CDx Partner evaluation and selection activities and manages multiple Companion Diagnostics Partnerships with Diagnostic Partner Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally For late-stage programs, executes the Diagnostic development strategy for a project under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscape Qualifications: (What are the minimum requirements for the position?) Education: PhD in Life Sciences or in related discipline preferred. MS degree in Life Sciences or in related discipline required. Experience: Minimum 3 years relevant work experience with PhD or 5+ years relevant work experience with MS Demonstrated track record of success working on multidisciplinary pharmaceutical /diagnostic development teams. Understanding of the IVD Development Process, with indirect or direct experience with Companion Diagnostics Development Broad knowledge and understanding of established and new assay technologies such as NGS, IHC, PCR etc. Knowledge of drug development process and an understanding of how diagnostic development can shape drug development and commercialization is strongly preferred. Competencies Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas. Strategic and analytical skills with a proven ability to define, prioritize and balance responsibilities in accordance with business and team needs. Experience maintaining strategic direction while ensuring successful execution of project details. Solid interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams and at managerial levels of the organization across various functions and locations Domestic and international travel may be required: 15% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orienttion, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Schwan's Company, a U.S. affiliate of the global lifestyle company, CJ CheilJedang Corporation, is a leading U.S. manufacturer and marketer of quality foods offered through retail-grocery and food-service channels. Our many popular brands include Red Baron, Tony's, Big Daddy's, Villa Prima and Freschetta pizza; Mrs. Smith's and Edwards desserts; and Pagoda and Bibigo Asian-style snacks. Schwan's is a place for people with an appetite for more. To learn about joining a team where you can belong, contribute, and thrive, visit We are hiring a PlantDirector for our largest pizza manufacturing facility in Salina, KS, where our delicious Red Baron and Tony's products are made. This is an opportunity to lead our most complex facility, which spans over 500K sq feet, employs 900+ team members and makes over 200 million lbs of product annually. This position is responsible for managing all aspects of the manufacturing facility to provide products that meet quality, safety, cost, service, regulatory and volume requirements. What you will get from us: Opportunities for career growth with one of THE fastest growing frozen food companies in the US. A culture focused on building trust, challenging assumptions, and continuous transformation. Support from team members who are experts in their functions. Competitive compensation including strong incentives and a flexible time off program. Responsibilities: Responsible for the manufacture of safe quality foods that meet the requirements of all regulatory agencies and our customers Implements plans and schedules to assure achievement of appropriate volume of production, ensuring product meets established targeted return on assets employed and contribution to sales and profits. Defines and directs the administration plant or facility policies within the framework and intent of the company's manufacturing charter. Formulates or approves short- or long-term operating objectives in areas such as cost reduction, quality, new product integration as undertaken at the plant level. Ensures product quality meets established standards and that costs are within budget. Assists in the development of and implementation of capital plans related to production improvement or expansion. Establishes and maintains favorable plant/facility company and community relationships through active participation in community affairs. Directs the maintenance of a safe and healthy working environment by eliminating hazards, training employees, and promoting safety awareness. Manages and/or provides appropriate support for support functions such as accounting/finance, human resources, information technology. Enthusiastically motivates, develops and inspires a team of site based professionals in production, quality, maintenance, engineering and more. Requirements: Minimum 8 years of operations leadership experience in a large scale, highly automated environment. Consumer packaged goods or food experience strongly preferred. Bachelor's degree or equivalent experience preferred. Experience achieving business growth objectives in fast pace, highly complex environment. Authentic leader: direct communicator, able to build strong relationships across the company, with all levels. Strong knowledge of continuous improvement techniques (ie TPM, OPEX, Lean) and ability to use data and systems to inform decisions. SAP experience a plus Must have great collaboration skills, with the ability to effectively work closely with cross-functional teams. FDA/USDA and OSHA experience highly preferred The employing subsidiaries of Schwan's Company are Equal Employment Opportunity Employers. All qualified applicants will receive consideration for employment without regard to disability, age, race, color, religion, gender, vet status, national origin, or other protected class.

Senior Director of Manufacturing Location : Maryland About Our Client : Our client is a leading biotech company at the forefront of innovation, focused on developing cutting-edge therapies that address unmet medical needs. With a diverse pipeline of small molecule and gene therapy projects, they are committed to advancing healthcare through scientific excellence and collaboration. Position Overview : We are recruiting a Senior Director of Manufacturing to lead and direct all aspects of Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical drugs and agents. In this critical role, you will oversee the manufacturing processes and analytical work associated with CMC across all small molecule projects and potentially gene therapy initiatives. This leadership position is key to ensuring successful product development and regulatory compliance as our client continues to advance its drug pipeline. Key Responsibilities : Oversee all CMC activities for small molecule pharmaceutical projects, including the development, manufacturing, and regulatory compliance of drug substances and products. Provide strategic direction and leadership for manufacturing operations, ensuring alignment with company goals and project timelines. Manage analytical development, including method development, validation, and stability studies, to support CMC activities. Ensure compliance with regulatory requirements (FDA, EMA, etc.) for manufacturing and quality standards across all projects. Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and external partners, to drive project success. Lead and mentor a team of scientists and engineers, fostering a culture of innovation, accountability, and operational excellence. Develop and manage CMC budgets, timelines, and resource allocation to optimize project delivery. Stay current with industry trends and technological advancements in CMC, applying best practices to manufacturing operations. Qualifications : PhD in Chemistry, Biochemistry, Chemical Engineering, or a related field. 10+ years of experience in CMC roles, with a strong background in pharmaceutical manufacturing, especially in small molecule drugs. Expertise in CMC regulatory requirements (FDA, EMA) and experience managing interactions with regulatory agencies. Proven leadership experience in directing manufacturing and analytical teams in a biotech or pharmaceutical environment. Strong problem-solving skills and ability to work in a fast-paced, dynamic environment. Excellent communication and collaboration skills, with the ability to manage cross-functional teams and external partners. Why Apply? This is a unique opportunity to play a pivotal role in the development and commercialization of life-saving therapies. If you are a driven leader with deep expertise in CMC and a passion for innovation, this role offers the chance to make a meaningful impact in a leading biotech company.

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 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 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. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International Conference on Harmonization (ICH) guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative research studies being highly desirable. Responsibilities: Lifecycle Management: Oversee and manage the complete lifecycle of externally sponsored research, including both IIS and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion. Operational Strategy: Develop and implement ESR team operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing potential issues proactively and ensuring adherence to timelines. Program Leadership: Lead and manage multiple research programs, demonstrating expertise in both strategy formulation and operational execution in the field of externally sponsored research. Provide clear direction and guidance to project teams. Committee Facilitation: Facilitate review committee meetings, ensuring comprehensive documentation of meeting outcomes, decisions, and action items. Coordinate with stakeholders to ensure timely follow-up and resolution of issues. Clinical Trial Management: Oversee clinical trial functions including CTA negotiations, Fair Market Value evaluations, milestone follow-ups, study enrollment updates, study reports, and closeout procedures. Work closely with study site operational staff to ensure timely and accurate updates. Project Management: Demonstrate advanced project management skills, facilitating discussions with internal and external cross-functional teams. Present findings and project statuses to cross-functional leadership and alliance management teams. Budget Management: Exhibit strong budget management experience, including forecasting, reforecasting, and managing plan vs. actuals. Preferably, have experience managing global studies involving multiple currencies and complex financial tracking. Vendor and Site Management: Direct and enhance interactions with investigator sites and other external vendors to ensure projects are delivered on time, within budget, and meet high-quality standards. Ensure effective communication and issue resolution. Communication and Collaboration: Foster and maintain effective communication channels within a global, multi-disciplinary team environment. Ensure alignment and collaboration across functions, regional ESR and Medical teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance: Understand study conduct from supply chain/drug forecasting to safety and regulatory requirements related to studies using investigational drugs and commercial products. Demonstrate experience in various types of studies across all phases, with a preference for oncology. People Management: This position may require the supervision of functional and/or direct reports by providing instruction and direction of daily activities in support of goals. Assume potential line management responsibilities for ESR Managers focused on the tactical aspects of study execution. In their absence, take on both strategic and tactical responsibilities to ensure study continuity and success. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) Bachelor's Degree in the Life Sciences required Master's Degree Life Sciences preferred Experience Qualifications 4 or More Years relevant working experience in externally sponsored research, including IIS and collaborative studies required 4 or More Years in a clinical management setting required A robust background in navigating complex regulatory environments and achieving study objectives efficiently and effectively required Strong understanding of Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines required Excellent communication, organizational, and problem-solving skills required Proven people management experience, demonstrating effective leadership and team development preferred Ability to travel up to 10% In-house office position that may require travel (global). 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.