Medical Director, Pulmonary
Sanofi
5 months ago
Remote friendly (Morristown, NJ)
United States
Medical Affairs
Main Responsibilities
- Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications and Publications, Health Outcomes, Safety, Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned therapeutic area products.
- Execute the Integrated Medical Plan to ensure on-time, on-budget delivery of tactical activities and deliverables.
- Communicate Medical Plan details and progress to Management, the Core Team, and execution partners.
- Provide data/evidence to define strategy consistent with clinical development and commercial objectives.
- Support generation and communication of scientific/medical insights; develop/execute Medical Engagement Plans.
- Provide medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners.
- Ensure cross-functional alignment to support safe and appropriate use of therapeutic area products.
- Provide medical leadership to sales, marketing, legal, and regulatory functions for marketed products and drugs in development.
- Provide scientific guidance and collaborate with field team, marketing, HEVA, Market Access, and sales.
- Partner with Field Medical Head and Medical Directors to manage regional stakeholder relationships, medical engagement planning, and tactical budget.
- Collaborate with Health Economics to address questions/opportunities.
- Review/approve promotional and medical materials for compliance with standards and regulations.
- Review/approve medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial materials.
- Review medical content for independent medical education grant applications and review training materials.
- Maintain knowledge and adherence to applicable guidance/regulation/law (e.g., FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR).
- Support US Phase IIIB-IV clinical study programs (protocols, CRFs, reports, SAPs, guidelines, reporting).
- Oversee clinical study conduct in line with GCP/ICH and company standards.
- Review/approve IST concepts/protocols per SOPs.
- Identify and co-create research collaborations; identify and oversee post-marketing trials/registries.
- Ensure company/investigator-sponsored trial data are publicly presented appropriately and timely.
- Partner with US Drug Safety on adverse events, post-marketing safety, and safety signal communication.
- Identify and communicate Product Alerts to the Core Team (with Drug Safety, USRAMP, GMA).
- Build relationships with Key Thought Leaders; lead and support advisory boards and advocacy.
- Represent the company at medical meetings/outreach; provide disease state and product training.
- Stay current on therapeutic area medical/scientific developments.
About You (Qualifications)
- Advance degree in life sciences or pharmaceutical sciences (PhD, PharmD, PA, NP, or MD with relevant experience).
- Minimum 5 years of relevant experience in Medical Affairs.
- Strong track record developing and executing US medical strategies.
- Clinical or medical affairs experience in Pulmonary 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.
Skills/Experience (Required/Preferred)
- Deep knowledge of healthcare systems, medical landscape, regulatory/payer environment, and industry trends.
- Sound scientific and clinical judgment; understanding of the scientific method and clinical applications.
- In-depth understanding of clinical trial design and conduct (clinical trial design/execution experience preferred).
- Ability to translate innovation into actionable plans; pragmatic and priority-focused.
- Strategic thinking; effective cross-functional stakeholder management.
- Broad leadership and strong “leadership presence.”
- Ability to influence decision-making in matrix environments.
- Ability to understand and communicate scientific/medical data.
- Excellent communication (written/oral) and presentation skills.
- High integrity, strong ethical standards, analytical skills, and change-management mindset (“Change Champion”).
- Knowledge of pharmacovigilance and local regulatory process.
- Digital literacy.
- Travel up to 35%.
Benefits
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications and Publications, Health Outcomes, Safety, Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned therapeutic area products.
- Execute the Integrated Medical Plan to ensure on-time, on-budget delivery of tactical activities and deliverables.
- Communicate Medical Plan details and progress to Management, the Core Team, and execution partners.
- Provide data/evidence to define strategy consistent with clinical development and commercial objectives.
- Support generation and communication of scientific/medical insights; develop/execute Medical Engagement Plans.
- Provide medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners.
- Ensure cross-functional alignment to support safe and appropriate use of therapeutic area products.
- Provide medical leadership to sales, marketing, legal, and regulatory functions for marketed products and drugs in development.
- Provide scientific guidance and collaborate with field team, marketing, HEVA, Market Access, and sales.
- Partner with Field Medical Head and Medical Directors to manage regional stakeholder relationships, medical engagement planning, and tactical budget.
- Collaborate with Health Economics to address questions/opportunities.
- Review/approve promotional and medical materials for compliance with standards and regulations.
- Review/approve medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial materials.
- Review medical content for independent medical education grant applications and review training materials.
- Maintain knowledge and adherence to applicable guidance/regulation/law (e.g., FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR).
- Support US Phase IIIB-IV clinical study programs (protocols, CRFs, reports, SAPs, guidelines, reporting).
- Oversee clinical study conduct in line with GCP/ICH and company standards.
- Review/approve IST concepts/protocols per SOPs.
- Identify and co-create research collaborations; identify and oversee post-marketing trials/registries.
- Ensure company/investigator-sponsored trial data are publicly presented appropriately and timely.
- Partner with US Drug Safety on adverse events, post-marketing safety, and safety signal communication.
- Identify and communicate Product Alerts to the Core Team (with Drug Safety, USRAMP, GMA).
- Build relationships with Key Thought Leaders; lead and support advisory boards and advocacy.
- Represent the company at medical meetings/outreach; provide disease state and product training.
- Stay current on therapeutic area medical/scientific developments.
About You (Qualifications)
- Advance degree in life sciences or pharmaceutical sciences (PhD, PharmD, PA, NP, or MD with relevant experience).
- Minimum 5 years of relevant experience in Medical Affairs.
- Strong track record developing and executing US medical strategies.
- Clinical or medical affairs experience in Pulmonary 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.
Skills/Experience (Required/Preferred)
- Deep knowledge of healthcare systems, medical landscape, regulatory/payer environment, and industry trends.
- Sound scientific and clinical judgment; understanding of the scientific method and clinical applications.
- In-depth understanding of clinical trial design and conduct (clinical trial design/execution experience preferred).
- Ability to translate innovation into actionable plans; pragmatic and priority-focused.
- Strategic thinking; effective cross-functional stakeholder management.
- Broad leadership and strong “leadership presence.”
- Ability to influence decision-making in matrix environments.
- Ability to understand and communicate scientific/medical data.
- Excellent communication (written/oral) and presentation skills.
- High integrity, strong ethical standards, analytical skills, and change-management mindset (“Change Champion”).
- Knowledge of pharmacovigilance and local regulatory process.
- Digital literacy.
- Travel up to 35%.
Benefits
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.