Medical Director, Rheumatology TA

About the role

We are searching for outstanding talent to join the Rheumatology TA team within the US Immunology Medical Affairs organization located in Horsham, PA as Medical Director, Rheumatology, US Medical Affairs.

Responsibilities

• Develop and execute (as Study Responsible Physician or Scientist [SRP/SRS]) Medical Affairs sponsored clinical study programs, including but not limited to Phase 3b/4 trials, registries, real-world evidence studies, investigator-initiated and/or collaborative studies in the Rheumatology TA.
• Contribute/lead study design, protocol development, clinical study report and publication development.
• Work closely with the matrix clinical trial teams and external investigators/KOLs on study operations and provide program leadership and medical oversight.
• Contribute to US Rheumatology Medical Affairs strategy, eg by leading one or more approved and pipeline Rheumatology products/indications Integrated Evidence Teams (IETs), working cross-functionally with partners within the Rheumatology Integrated evidence team (IET), including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing team brand leads, as well as potentially Rheumatology Disease Area Stronghold (DAS), R&D, Global Medical Affairs and Global Commercial partners to promote and execute the Rheumatology TA Strategy for establishing access as well as plans for and progress and outcomes for evidence generation activities and Data Dissemination Plans.
• Contribute to the preparation of regulatory submissions and interactions with Health Authorities (and particularly the FDA) and helps to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods.
• Contributes to, and potentially leads (as the IETL), the cross-functional team to develop and maintain a current, strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline Rheumatology products/indications.
• Support the fulfillment of medical information requests from field medical and field commercial teams.
• Support/ lead the development of medical education content for field medical team.
• Partner with medical communications and scientific exchange teams on content development, review, and approval.
• Identify new key opinion leaders (KOLs) and develop strong KOL collaborations on clinical trial development and medical affairs activities.
• Establish and foster relations with medical societies and patient advocacy organizations.

Qualifications

• An advanced degree (MD/DO, PhD, PharmD, DNP, etc.) is required.
• A minimum of 8 years of combined relevant experience in academic clinical research, clinical practice, and/or pharmaceutical industry with include a history of accountability for key deliverables with demonstration of their timely and successful execution is required.
• Rheumatology or Immunology Therapeutic Area expertise is strongly preferred.
• Prior industry/medical affairs experience, including commercial brand support, medical launch support experience, and clinical study, registry, or real-word evidence study support and execution is preferred.
• Prior R&D experience with responsibility and accountability for clinical study planning and execution is also a strong asset.
• Excellent analytical and strategic thinking aptitude, scientific writing proficiency, and strong organizational, written, and verbal communication skills, including proficiency in effective and impactful scientific oral presentations is essential.
• Strong leadership, teaming, and collaboration skills and the ability to work in a matrix environment, collaborating effectively with many cross functional partners and succeed in participating in and leading cross functional teams to execute on deliverables is essential.
• Up to 25% travel (primarily domestic & limited international) is required.