Sanofi EU

Job Title: US Sr. Medical Director, Dermatology and Rheumatology Location: Cambridge, MA, Morristown, NJ About the Job Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. Our Sanofi Immunology Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients' needs. The US Medical Immunology team is proud to support Sanofi's deep commitment to chasing the miracles of science to improve the lives of patients. We shatter treatment inertia through our commitment to leaving no Type 2 inflammation patient behind. We aim to transform medical practice, deliver innovative and actionable data to providers and payers enabling timely patient identification and driving the urgency to act on debilitating immunological disorders. Lead the Dermatology/Rheumatology, US Medical Immunology team, as a valued strategic partner with Clinical, Commercial, Regulatory and Market Access to bring innovative therapeutic solutions to improve the lives of patients and establish Sanofi as a leader in Immunology. The US Medical Franchise Head, Dermatology/Rheumatology is responsible for orchestrating the seamless integration of the medical capabilities to deliver comprehensive solutions that address the holistic needs of customers and patients. This leader is responsible for developing the U.S. medical strategy and tactical plan for their entire Therapeutic Area, the MSL Field strategy/leadership and operations to ensure delivery. This includes a strong partnership with global, alliance management and the relevant U.S. cross-functional partners and ensuring these plans are tailored to the local needs and resources, both on data generation and all aspects of engagement with the scientific community. This position will be responsible for managing the disease area directors that are part of the US Medical Franchise team, ensuring consistency in the approach and strong partnership and global collaboration with the cross-franchise teams, global medical and cross-functional partners. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Coach, train and manage the the disease area directors' team performance and development to ensure excellent execution of their role and of strategic goals. Provide leadership to the Dermatology/Rheumatology, US Medical Immunology team (Medical Directors, Medical Science Liaison Managers, MSLs & Medical Operations Manager) by cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities, while attracting, developing and retaining top talent. In collaboration with Global and Alliance Medical partners, be accountable and lead the development of an Integrated Medical Plan (MSLs, IME, Medical Communications and Publications, Health outcomes, Safety and Clinical Research (phase IIIB-IV and ISTs and annual budget for the respective Therapeutic Area. Lead and monitor the execution of the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables. Communicate the details and progress of the Medical Plan to Senior Management, the Core Team and all parties responsible for execution. Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of our products - including the alignment across the US Immunology franchise. Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans, and manage MSL resources and budgets. Partner with Field Medical Head, Medical Directors, and other internal partners to manage high-level regional stakeholder relationships, contribute to medical engagement planning, and oversee the MSL budget. Identify and support MSL managers on opportunities for innovation and field excellence initiatives to differentiate Sanofi medical and help achieve and exceed department objectives. Analyze data to optimize resources and support MSL field force planning for product life cycles, including pre-launch. Develop recruiting plans and responsible to recruit, hire, develop, and manage medical talent, and secure approval for headcount changes to support the HO team's needs. Co-develops recruiting plans and works with the Field Medical Head to secure approval for headcount changes to support the MSL team's needs Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development. Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR). Lead the review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s). Identify and communicate Product Alerts to the Core Team (in conjunction with U.S. Drug Safety, USRAMP, GMA). Partner with U.S. Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals. Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) and relevant professional organizations. Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc. Performs other duties as assigned. About You Advanced degree required (PhD, Pharm.D., or equivalent) with relevant experience. A minimum of 7 years relevant experience in Medical Affairs leadership Clinical or Medical Affairs experience in Dermatology, Rheumatology or other relevant Immunology therapy area Knowledge of pharmacovigilance and local regulatory process. High degree of knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends to accurately identify key issues and develop strategies. Ability to effectively participate in multi-disciplinary teams to set and meet business goals and objectives. Thinks strategically leveraging knowledge of general business practice, the industry, medical practice and Sanofi strategic objectives to create a team strategy to achieve commitments. Proven ability to utilize appropriate time and project management strategies and agility, to manage complex environment and motivate and guide management teams with the multiple skill levels. Demonstrated record of people-development Proven record of successful change management, a 'Change Champion' mindset Digital literacy Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Job Title: Medical Director, Rheumatology Location: CX or M Station Travel: Ability to travel up to 35% of the time to customers, external meetings, trainings, and other internal meetings. About the Job Our Sanofi Immunology Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients' needs. The US Medical Immunology team is proud to support Sanofi's deep commitment to chasing the miracles of science to improve the lives of patients. We shatter treatment inertia through our commitment to leaving no patient behind. We aim to transform medical practice, deliver innovative and actionable data to providers and payers enabling timely patient identification and driving the urgency to act on debilitating immunological disorders. The Medical Director, Rheumatology functions internally as the product expert to lead the development and execution of the most efficient and integrated US medical/scientific strategy for rheumatology products, including scientific evidence generation and scientific information exchange with all key stakeholders. As a valued strategic partner with the Medical Field Team, Clinical, Commercial, Regulatory and Market Access this role is essential to success is an outstanding partnership to maximize the value proposition. Externally, the role assists healthcare professionals and payers to optimize patient care and treatment outcomes through evidence-based decisions. This medical leader is responsible for co-developing the U.S. medical strategy and tactical plan for their entire Therapeutic Area, the MSL Field strategy/leadership and operations to ensure delivery. This includes a strong partnership with global, alliance management and the relevant U.S. cross-functional partners and ensuring these plans are tailored to the local needs and resources, both on data generation and all aspects of engagement with the scientific community. Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main responsibilities: Develop strategy and tactics for an integrated Medical Plan (Medical Science Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned rheumatology products. Execute the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities and deliverables. Communicate the details and progress of the Medical Plan to Management, the Core Team, and all parties responsible for execution. Provide relevant data evidence to ensure that strategy is clearly defined and consistent with clinical development and commercial strategic objectives. Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans. Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners. Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of rheumatology products, cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities. Provide medical leadership and expertise to sales, marketing, legal, and regulatory functions for marketed products and drugs in development. Pro-actively provide guidance and collaborate with field team, marketing, HEVA, Market Access, and sales teams. Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans, and manage MSL resources and budgets. Partner with Field Medical Head, Medical Directors, and other internal partners to manage high-level regional stakeholder relationships, contribute to medical engagement planning, and oversee the MSL budget. Collaborate with the health economics team to address questions and opportunities. Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations. Review and approve medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial materials. Provide medical review of applications for independent medical education grants. Provide medical review of training materials for medical and commercial employees. Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law (including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR). Support the execution of US Phase IIIB-IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines, and accurate and timely reporting of study data. Oversee conduct of all clinical studies in adherence to both Company standards and government/industry regulations (GCP/ICH). Review and approve IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOPs. Identify and co-create research collaboration opportunities within the rheumatology therapeutic area to address key questions in the delivery of patient care. Identify needs for post-marketing clinical trials and registries and oversee their management and execution. Ensure that all data generated by the company or investigator-sponsored trials are publicly presented in an appropriate and timely fashion and in a fair and balanced manner. Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals. Identify and communicate Product Alerts to the Core Team (in conjunction with US Drug Safety, USRAMP, GMA). Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within the rheumatology medical and scientific community. Lead medical and scientific advisory board discussions to identify and elevate medically focused opportunities, resources, and strategic action within rheumatology. Foster the establishment and maintenance of external scientific advisory boards and assist in advocacy development. Interact with experts at medical meetings, advisory boards, and outreach meetings to represent Sanofi and strengthen its reputation in rheumatology. Provide disease state and product training to internal and external stakeholders. Remain informed of current developments within the rheumatology medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, and professional associations. Performs other duties as assigned. About You Minimum 5 years of relevant experience in Medical Affairs. Strong track record in developing and executing medical strategies in the US. Clinical or medical affairs experience in Rheumatology and/or Immunology strongly preferred. Industry experience in Medical Affairs and/or Clinical Development, with significant experience in Medical Affairs Launch and Life Cycle Management activities. High degree of knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends to accurately identify key issues and develop strategies. Sound scientific and clinical judgment, including an in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale. In-depth understanding of how to conceptualize, design, and conduct clinical trials. Experience in clinical trial design and execution preferred. Ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities; ability to translate innovative strategies or solutions into actionable plans. Thinks strategically leveraging knowledge of general business practice, the industry, medical practice and Sanofi strategic objectives to create a team strategy to achieve commitments. Effective internal and external stakeholder management; politically astute with strong cross-functional teamwork and collaboration. A team player; able to collaborate successfully with both internal and external colleagues. . click apply for full job details

Job Title: US Senior Medical Director, Neurology Location: Cambridge, MA, Morristown, NJ About the Job Our Team: This position will report into the US Medical Next Gen Immunology team, a segment of the Medical Specialty Care organization. Our Medical function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients' needs. The US Medical Immunology team is proud to support Sanofi's deep commitment to chasing the miracles of science to improve the lives of patients living with neurological conditions, including multiple sclerosis and chronic inflammatory demyelinating polyneuropathy (CIDP). Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you'll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Provide strategic leadership to the US Medical Affairs Next Gen Immunology team (Medical Directors, Medical Science Liaison Managers, and Medical Science Liaisons) by cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities while attracting, developing, and retaining top talent. Manage a team of Medical Directors and a Field Medical Director responsible for field training and MSL operations. Provide values-guided management of direct reports aligned with Sanofi's core values: Aim Higher, Act for Patients, Be Bold, and Lead Together. Develop strategy and tactics for an integrated Medical Plan encompassing Medical Science Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research (Phase IIIB-IV and Investigator Sponsored Trials) across the neurology pipeline. Provide cross-portfolio medical strategy and scientific expertise to Clinical, Commercial, Market Access, and Regulatory partners at both Global and US levels. Lead medical and scientific advisory boards to capture insights and translate findings into actionable medical strategy. Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations. Support the execution of US Phase IIIB-IV clinical study programs. Support the review and approval of Investigator Sponsored Trial concepts and protocols according to applicable SOPs. Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and communication of identified safety signals. Develop and maintain close professional relationships with Key Thought Leaders (healthcare practitioners and researchers) within the medical and scientific community. About You Education: Advanced degree in a scientific discipline is required: MD, PhD, PharmD or equivalent. Experience: A minimum of 7 years of experience in Medical Affairs with experience in Pre-Launch, Clinical Development, Launch and Life Cycle Management activities. Experience in cross-portfolio Neurology areas required. Strong track record in developing and executing medical strategies in the US. Strong people management and development experience. Experience in Ophthalmology preferred. Skills and Knowledge: Executive Presence: Entrepreneurial mindset with the ability to influence at senior levels. Clinical Development Expertise: Strong knowledge of clinical development processes and regulatory requirements. Scientific Acumen: In-depth understanding of the scientific method with the ability to apply insights for business needs based on medical and scientific rationale. Stakeholder Management: Effective internal and external relationship building with strong cross-functional collaboration skills. Strategic Thinking: Ability to challenge the status quo with innovation while remaining pragmatic and focused on priorities; translates strategies into actionable plans. Results Orientation: Driven to develop and execute optimal strategies meeting corporate objectives; comfortable with ambiguity and able to adapt with agility, take calculated risks, and anticipate potential issues. Why Choose Us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Job Title: Clinical Research Director Location: Cambridge, MA, Morristown, NJ About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. Reporting to the Global Project Head, the CRD leads clinical trial strategy of assigned program(s) within the clinical development team, including interactions with Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan. The clinical development team further develops a compound through life cycle management. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies. Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to: Authors abbreviated protocol. Reviews the final protocol and protocol amendments. Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form. Reviews the study specific committee charters. Leads study specific committees with operational support. Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries. Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine Participates and contributes to regulatory and safety documents and discussions Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIP Participates in Advisory Committee preparation Scientific data evaluation and authorship Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate Supports the planning of advisory board meeting. Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate About You Job Requirements: MD degree or equivalent, with Medical Oncology fellowship. Hematology/Oncology fellowship or experience (4+ years) in Oncology Development Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years), Experience in clinical development, late-stage preferred Demonstrated ability to interact productively with external investigators Demonstrated ability to work with a multifunctional team to achieve project milestones Understanding of and willingness to meet applicable regulatory, quality and compliance standards Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Job title: Global Head, Regulatory Science - Model-Enabled Development, Real World Evidence and Novel Endpoints Location: Morristown, NJ About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions. The Global Head, Regulatory Science - Model-Enabled Development, Real World Evidence & Novel Endpoints serves as a specialized center of excellence within Sanofi's Regulatory framework, driving innovation in regulatory science through advanced model-informed approaches, real world evidence and novel endpoint development. We accelerate drug development timelines by providing expert guidance on Model-Enabled Drug Development frameworks, regulatory validation of new endpoints, real-world evidence data and cutting-edge regulatory strategies across therapeutic areas. We bridge the gap between R&D innovation and regulatory acceptance, partnering closely with Translational Medicine, Clinical Development, Biostatistics, and other key functions to ensure regulatory considerations are integrated early in the development process. With a commitment to Sanofi's "Take the Lead" values, particularly in "Leading Together" and "Being Bold," our mission is to establish GRA as a leader in new regulatory strategies while ensuring patient-focused outcomes and maintaining the highest standards of scientific rigor. Through strategic engagement with regulatory agencies and cross-functional collaboration, we enable faster, smarter development pathways that bring innovative healthcare solutions to patients worldwide. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities Provides Leadership and Strategic Vision: Accountable for organizational design, people development (supervising, coaching, mentoring), resource allocation (recruitment, retention, talent development, succession planning), and metrics for the expert unit. Demonstrates very strong leadership including influencing and negotiating skills, and conflict management and resolution. Capable of resolving and/or advising on very complex global organizational and regulatory/technical issues related to model-enabled development, regulatory real-world evidence and novel endpoints strategies. Demonstrates the knowledge and behaviors that model the Sanofi and GRA Values/Principles/Competencies. Establishes the team as a center of excellence for model-enabled regulatory strategies and submissions. Develops and Implements Innovative Regulatory Strategies: Oversees the development of comprehensive regulatory strategy frameworks for Model-Enabled Drug Development across all development phases, in collaboration with Global Regulatory Leads (GRLs) and other parts of GRA. Leads regulatory validation projects (e.g., C-Peptide endpoint validation, iBox ) from concept to approval, ensuring alignment with R&D product project timelines. Assures that positive and collaborative relationships are developed with R&D partners (TMU, Clinical Development, Biostatistics) to achieve implementation of appropriate model-enabled regulatory / real world evidence regulatory strategies. Ensures that regulatory considerations are integrated early in development projects and that risks are identified, communicated, and mitigated as necessary. Leads Strategic Engagement with Regulatory Agencies: Oversees strategic negotiations and engagement with worldwide Regulatory Agencies, including directly with FDA and EMA, on emerging model development topics, MIDD approaches, real-world evidence and novel endpoints. Develops and implements health authority engagement plans to advance acceptance of innovative regulatory strategies. Assures appropriate representation of Sanofi at Agency meetings and scientific working groups; assures that contacts with Agencies are initiated and addressed in an effective and timely manner, whilst developing positive and favorable relationships with Agencies on cutting-edge regulatory science topics. Drives Knowledge Management and Capability Building: Provides vision and leadership for building specialized regulatory expertise in model-enabled development, real-world evidence approaches across the global GRA organization. Oversees the creation and dissemination of best practices, SOPs, training materials, and knowledge management platforms for such expertise and case studies. Partners with the Regulatory Capability and Learning Solution Lead to develop and deliver training curriculum and capability development programs. Monitors and communicates current Health Authorities thinking, regulatory trends, and paradigm shifts in model-enabled development, real world evidence and novel endpoints. Assures that the team takes a leadership role externally through participation in industry consortia, working groups, and professional associations. Ensures Excellence in Regulatory Submissions and Cross-Functional Collaboration: Oversees the preparation, review, and approval of model-enabled regulatory submissions, real evidence and novel endpoint validation packages to assure they meet appropriate quality standards and scientific rigor. Drives cross-functional project delivery efficiency through matrix collaboration with R&D counterparts. Assures that complex technical and regulatory issues related to modeling, simulation, and new endpoints are appropriately resolved with optimal solutions. Establishes clear governance and decision-making processes to enable efficient project execution and milestone achievement. About You Requirements Core Experience: Minimum 10-15 years of regulatory affairs experience with demonstrated progression in regulatory roles and successful regulatory authority interactions. Direct experience with Model-Informed Drug Development (MIDD), pharmacometrics, modeling and simulation, and/or novel endpoint development is highly desirable. Proven track record of successful regulatory submissions involving advanced modeling approaches or innovative endpoints. Leadership Background: Demonstrated leadership experience in building and developing specialized teams, including organizational design, people leadership and development (supervising, coaching, mentoring), recruitment, retention, talent management and succession planning. Experience establishing centers of excellence or expert units is highly valued. Ability to lead through influence in a matrix organization and drive cross-functional collaboration. Technical and Regulatory Expertise: Strong knowledge of Model-enabled frameworks (e.g., FDA MIDD Pilot Program), regulatory pathways for novel endpoint validation, and key Agency thinking and trends in regulatory science innovation. Capable of resolving complex strategic technical and regulatory issues related to modeling, simulation, and endpoint development. Experience working with or for a Regulatory Health Authority is helpful but not essential. Education: Bachelor's degree required. Advanced degree (Masters, Pharm D, PhD) in a quantitative science field (e.g., Pharmacometrics, Biostatistics, Pharmacology, Clinical Pharmacology, Translational Medicine, Computational Biology) or health sciences field, or equivalent is highly desirable. Communication Skills: Demonstrated excellent communication and influencing skills internally and externally, with the ability to translate complex technical concepts for diverse audiences. Proven ability to build and maintain effective partnerships with health authorities, R&D functions, and external stakeholders including industry consortia. Strategic Thinking: Demonstrated ability to assess regulatory risks and opportunities in emerging areas, develop pragmatic and innovative solutions that align with business objectives, and anticipate future regulatory trends. Demonstrated independence in thinking, anticipatory foresight, and ability to communicate effectively to broad, sophisticated, formal/informal, internal and external audiences. Collaborative Leadership: Experience building and maintaining effective partnerships across functions (particularly with Translational Medicine, Clinical Development, Biostatistics, Medical Affairs) and with external stakeholders. Proven ability to drive knowledge sharing and capability building across organizations. Travel: 10% travel expected, domestic and international Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender . click apply for full job details

Job Title: Senior Manager Federal Government Contracts US About the Job The Senior Manager, Government Accounts will report to the Director, Government Accounts and is responsible for recommending and implementing government contracting and pricing strategies for vaccines, managing contract negotiations while executing approved strategies, and all aspects of account management for and in compliance with various government agencies/contracts, including the calculation and remittance of all fees/rebates for government contracts. This role will also support the Director, Government Accounts with various internal/external reporting requirements and ad hoc projects relating to government accounts. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: Responsible for supporting the Director, Government Accounts in the development and submission of all vaccine government bids, contract execution, and account management for government accounts, including CDC, US Military and Dept of Veterans Affairs. This includes strategy development, negotiations, oversight and implementation of contract strategy, terms, conditions, bid submission, contract negotiations, demand management, field communications, reporting requirements (both internal and external) of prebooks/shipping/compliance reports, and performance while ensuring compliance with contractual requirements and all applicable laws. Work closely with the Pricing department to implement price changes and monitor competitive intelligence in order to react and implement price changes on contracts, if necessary. Must understand the implications of any proposed strategies on the terms of government contracts as strategies are developed and presented to leadership. Communicate appropriately with the government agencies as strategies are approved and implemented. Responsible for all government contracts' fees/rebates calculations and payments utilizing multiple internal and external reporting systems, including quarterly payment processing of the VA FSS Sales and Industrial Fee (IFF) and Medicare Part D Manufacturer Discount Program. Day-to day operations/decisions include account management, government contract eligibility and customer account problem resolution. Prepare business cases and recommendations for review by various groups and individuals, including leadership, as appropriate. Represent government accounts on various internal stakeholder calls, including Influenza Core Team. Key point of contact for responding to all government contract related internal/external audit requests by the required deadlines. Support the Director, Government Accounts on various account management activities, including CDC Flu and Mainline contract reporting requirements and ad hoc special projects. About You Basic Qualifications: Bachelor's degree is required. Advanced degree preferred 3+ years of contract/account management Strong negotiation, written/oral communication, organizational and analytical skills High attention to detail and problem solving Strong computer skills including Excel, Word, PowerPoint, SharePoint and Teams Must be able to work independently, initiate and carry out multiple projects until completion Demonstrated ability to manage multiple shifting priorities and delivering quality results under tight deadlines Preferred Qualifications: 5 or more years of experience in pharmaceutical and/or healthcare government contracting or sales Familiarity with U.S. Government contracts Experience working with various government agencies across a wide range of contracting types including CDC, VA, DoD, Tricare, and VA FSS In-depth working knowledge of Microsoft Office (Word, Excel, PowerPoint), SAP, MicroStrategy/Power BI, and RMGP/Model N from a master data user functionality (product management, contract setup & pricing, and adjudications & settlements) Working knowledge and experience of Federal Acquisition Regulation (FAR) for government procurement process Internal/External Audit experience Business skills and credibility to advise and influence various levels of leadership Creative and innovative problem-solving skills Excellent teambuilding and situational leadership skills Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Job Title: Head of Commercial Strategy and Marketing Operations Location: Morristown, NJ, Cambridge, MA About the Job Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization. You will be joining the US Vaccines team to lead the Commercial strategy and Marketing operations group working closely with local and global teams to define, orchestrate and implement portfolio and operational deliverables. Key collaborators include the US Vaccine Franchises, Sales teams across Health systems, Retail, portfolio sales, Operations, Digital, Customer Service and Global Brand Excellence. About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives. Main Responsibilities: Develop and Lead strategic projects across the portfolio working cross functionally across the organization related to short term and mid term priorities of the business. (e.g., competitive benchmarking, go-to-market evolution, resource allocation, channel & segment strategy) Lead annual strategic and operational planning exercise coordinating with US business franchises and North America Leadership team Drive marketing operations and excellence (includes partnering on omnichannel capabilities, annual sales meetings, congress/conventions, Control tower for priorities, other) Design and deliver cross brand initiatives working across marketing, sales, advocacy, medical. Examples include non-branded disease awareness materials (e.g., vaccine confidence campaign), articulating Sanofi competencies and positions on relevant public health topics. Develop the Sanofi Vaccines congress/conference strategy building a One Sanofi plan with medical. Attract, retain, develop and lead a team of marketers and marketing operations professionals , 5 + people, fostering talent development and capability building while role modeling Sanofi leadership behaviors. Engage with external stakeholders on behalf of Sanofi Vaccines. Member of the Marketing and Commercial Strategy Executive Leadership Team. About You Experience & Qualifications: Required: Bachelor's degree 8-10+ years of progressive experience in product/brand management, strategic marketing, commercial operations, or business development required, preferably within the pharmaceutical or biopharmaceutical industry Proven track record in developing and deploying business strategies across multiple customer channels (medical, health systems, specialty markets, wholesale/distribution, or public sector) Strong analytical and strategic thinking skills with demonstrated ability to drive business results Comprehensive understanding of the U.S. healthcare environment dynamics and market access landscape Experience leading, developing, and building high-performing teams Knowledge of U.S. commercial segments and channels Business operations and support experience Travel: Up to 25% travel required, domestic and international Hybrid work environment: 3 days per week in the office Preferred: Advanced degree (MBA, Master's equivalent) 3+ years of strategic consulting experience or strategy experience at a major pharmaceutical company in the U.S. Knowledge of the U.S. Vaccines sector and immunization landscape Experience in omnichannel marketing and digital engagement strategies Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.