Medical Director Rheumatology - US Medical Affairs

About Immunology

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Purpose

This role will be a key member of the Medical Affairs Rheumatology Therapeutic Area (TA) Team and will report to the Head, Therapeutic Area Lead Rheumatology, US Medical Affairs- Immunology. They will work closely with other Rheumatology Medical Directors as well as partners in US and Global Medical Affairs, Real World Value and Evidence (RWV&E), Population Health, Epidemiology, R&D, Biostatistics, and US and Global Commercial Team members to create, shape, influence and drive strategy for Rheumatology pipeline and approved products including evidence generation plans and subsequent execution, ensuring alignment with business objectives and regulatory standards.

Responsibilities

• Contribute to US Rheumatology Medical Affairs strategy by leading one or more approved and pipeline Rheumatology products/indications and Integrated Evidence Teams (IETs), working cross-functionally with partners including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Field Value & Evidence, Strategic Customer Group, Marketing team brand leads, R&D, Global Medical Affairs and Global Commercial partners.
• Contribute to and potentially lead 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, and support payer-related materials and data needs to scientifically support market access efforts.
• May develop and execute (as Study Responsible Physician or Scientist [SRP/SRS]) Medical Affairs sponsored clinical study programs, including 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 matrix clinical trial teams and external investigators/KOLs on study operations and provide program leadership and medical oversight.
• Contribute to the preparation of regulatory submissions and interactions with Health Authorities/FDA and help ensure regulatory post-marketing commitments are efficiently satisfied.
• Review and evaluate Investigator-Initiated Study (IIS) concepts, champion prioritized concepts through appropriate review, approval, & funding, and monitor study progress/milestones.
• Contribute as a subject matter expert on previous and new data in support of US Immunology approved (or planned) drugs and indications, partnering with marketing brand teams and other commercial and IET partners.
• Partner with individuals in Rheumatology TA and other groups inside and outside Medical Affairs (e.g. Biostats, GCO, Regulatory Affairs, QA and QC) to create Analysis Plans, safety data review for database locks and ensure compliance with study monitoring and other SOP/GCP requirements.
• 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.
• Contribute to or lead the development of abstracts and manuscripts related to J&J supported and sponsored studies.
• 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 / Requirements

• Advanced degree (MD/DO, PhD, PharmD, DNP, etc.) is required.
• A minimum of 8 years of combined relevant experience in academic and/or clinical research, clinical practice, and/or pharmaceutical industry with a history of accountability for key deliverables with demonstration of their timely and successful execution is required.
• Experience including commercial brand support, medical launch support experience, and clinical study, registry, or real-world evidence study support and execution are essential.
• Prior R&D experience with responsibility and accountability for clinical study planning and execution is an asset.
• Rheumatology or Immunology Therapeutic Area expertise is strongly preferred.
• Pharmaceutical industry experience is required.
• Medical affairs experience is highly preferred.
• 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.
• Excellent interpersonal and public speaking skills, and experience interacting with health care professionals and other thought leaders 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.
• Demonstrated commitment to learning emerging technologies, such as AI, through exploration, iteration, and applying new tools over time.
• Up to 25% travel (primarily domestic & limited international) is required.

This position is located in Horsham, PA and follows a hybrid schedule of three days in the office and two days remotely per week.