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. #J-18808-Ljbffr
Medical Director, Pulmonary
SCORPION THERAPEUTICS
morristown, morristown
Published 4 days ago
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