Job Title: US Medical Director, Mainline VaccinesLocation : Bridgewater, NJ / Morristown, NJAbout the JobThe North American Medical Team at Sanofi is a high-performing team of Medical leaders who are a trusted source of scientific and medical information and shared insights; effective and innovative strategic partners to our internal and external stakeholders; and dedicated to public health and empowering lives through immunization. We represent diverse experiences and backgrounds which strengthens our team and mirrors the healthcare communities we engage.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:The US Medical Director, Mainline Vaccines, will contribute to development and execution of the medical and scientific (non-promotional) strategy for the franchise portfolio in the US. The US Medical Manager is accountable for the medical plan within their defined franchise and scope including the medical plan, data generation, scientific exchange, and stakeholder engagement.Strategy
Act as a cross-functional partner to provide support within the US Medical team and work in close partnership with other departments including brand teams and Public Affairs
Play a leadership role in developing, executing, and contributing to the Country Medical Roadmap (CMR) through close collaboration with the Franchise Medical Head as well as demonstrating active involvement in the annual cross-functional brand planning process.
Ensure alignment of the US medical strategy with the Global medical strategy through co-creation within the global medical team
Play a leadership role in shaping medical strategy at global, regional, and local levels, ensuring alignment with US Medical strategic objectives, while monitoring publications outlined in the CMP and determining appropriate dissemination to targeted external stakeholders through collaboration with the Franchise Advisor, External Scientific Exchange, and other key personnel, as well as contributing to congresses, publications, and NITAG engagements.
Act as the country Medical expert for the Integrated Evidence Generation Plan (iEGP), providing strategic guidance and serving as the key liaison between global Medical, the Principal Investigator (PI), and the US Medical Team on Sanofi-sponsored studies, as delegated by the Franchise Medical Head
External Stakeholder Engagement
Identify, establish, build, grow, and maintain strategic relationships with senior experts, key opinion leaders (KOLs), professional societies, immunization advisory bodies, patient advocacy groups, decision makers and other external stakeholders, acting as SME and fostering scientific engagement to strengthen their understanding of our products and to collaborate on high-priority global studies and scientific initiatives.
Provide external scientific education on disease states, epidemiology, and clinical trials of Mainline vaccines product(s), support company positions, and provide guidance on company products and related medical issues.
Evaluate Medical educational grant requests stringently in accordance with internal operating procedures and aligned to Country Medical Plan (CMP)
Lead external advisory boards organized to support the medical strategic objectives and/or medical plan.
I nternal Collaboration/Communication
Provide significant scientific expertise within and outside the mainline vaccines team.
Work with cross-functional internal stakeholders, in particular field medical, to development strategic imperatives and downstream strategies and tactics to support our goals.
Provide training to field-based medical team on all current and new publications and related assets in collaboration with NA Training Lead.
Provide medical guidance to internal Sanofi customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health authorities.
Collaborate with marketing teams to link sound evidence to brand strategy.
Represent as country medical expert in all product label updates and product Company Core Datasheet (CCDS) updates.
Data Generation
Work with R&D and Clinical Development teams to provide medical input to the design and support the execution of company-sponsored clinical trials (i.e., Ph 4 post-marketing and observational studies) for new products that may join franchise portfolio in accordance with integrated evidence generation plans (iEGP)
Partner with R&D and Clinical Development teams to write, review, edit, and approve key regulatory documents.
Engage Key External Leaders (KOLs) to apply for support for ISSs that are aligned with Life Cycle Management and Global Brand Team (GBT) strategies.
Liaise with Medical Study Leader to oversee investigator-initiated study (IIS) process from end to end including:
Review ISS and ESC applications
Liaise with the investigators of study applications.
Present studies to the GMT and SRC
Follow study progress to completion including eventual publication.
Medical Operations
Participate as subject matter expert on multi-disciplinary Review Committee (RC) meetings for medical review and approval of all materials and messaging intended for external use.
Contribute to the development and management of specifically owned franchise budget line items by tracking expenditures and executing plans in a cost-effective manner in collaboration with the Franchise Medical Strategy Planner
Scientific Content
Monitor publications outlined in CMP and determine the appropriate assets to be created aligned with the CMP and targeted external stakeholders in collaboration with Medical Advisor
About YouRequirementsEducation/Experience/CertificationBasic Qualifications:
Advanced degree in scientific or healthcare-related field (vaccinology, immunology, microbiology and/or infectious disease)
5+ years in Medical Affairs within the pharmaceutical / biotechnology industry
Relevant clinical experience or track record of peer reviewed publications in the US
Ability to travel up to 20% of the time.
Knowledge of US health care system, communicable disease control, public health, and immunization practices
Preferred Qualifications :
Prior experience in an external stakeholder facing role (i.e., governmental collaboration)
Recognized by other vaccine experts as being expert in vaccinology or a related discipline.
Infectious diseases and/or vaccine experience either from academia/research and/or preferably from the pharma industry with relevant customer knowledge
Competencies that the successful candidate should possess:
Developed business acumen to support compelling and effective Medical strategies that serves to benefit patients, HCPs, and other key external stakeholders.
Ability to understand and effectively communicate vaccine clinical studies, both interventional and observational
Knowledge of vaccine study design and interpretation (interventional and observational)
Infectious diseases and/or vaccine experience either from academia/research and/or preferably from the pharma industry with relevant customer knowledge
Ability to successfully manage multiple projects simultaneously; plan, prioritize and implement actions using a self-dependent and structured working style.
Excellent interpersonal, communication, influencing and networking skills with an ability to work as part of a cross-functional and multicultural team.
Effectively engage with key external stakeholders and build long-term partnerships with medical authorities, hospitals, physicians/specialists, opinion leaders and pharmacists.
Ability to analyse information and emerging trends, including social, policy and access-related information, and incorporate them into the medical plans.
Develop scientific communication and education initiatives using scientific/medical expertise, customer insights and understanding of launch strategy; train and educate internal and external stakeholders.
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.#GD-SP #LI-SP#LI-Onsite#vhdPursue progress , discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !US and Puerto Rico Residents OnlySanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
