Medical Director, Autoantibody, Pipeline - US Medical Affairs

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

Scientific/Technology

All Job Posting Locations:

Horsham, Pennsylvania, United States of America

Description:

We are searching for the best talent forMedical Director, Autoantibody Medical Affairs within our US Immunology Medical Affairs organization located inHorsham, PA.

About Immunology

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at [https://www.jnj.com/innovative-medicine](https://www.jnj.com/innovative-medicine)

As a part of US Medical Affairs Immunology, the Medical Director, Autoantibody Medical Affairs, will contribute to the strategic planning and execution of Phase IIIb & IV trials, post-marketing requirement studies, investigator initiated or collaborative studies, serving as a study responsible physician/scientist (SRP/SRS) for select medical affairs trials. The Medical Director, Autoantibody Medical Affairs will contribute/lead the advancement of protocol development, medical / data monitoring, study operations, data analysis / reporting, writing of study reports and publications, as applicable. Additionally, the Medical Director will partner with colleagues on real-world evidence, health economic and outcomes research, biostatistics, and work with commercial marketing colleagues through integrated evidence teams and other touchpoints to formulate and execute activities in support of the Autoantibody TA strategy across the asset, prioritizing key indications, with a focus on maternal fetal medicine and warm autoimmune hemolytic anemia.

You will be responsible for:

• Work with the Autoantibody Therapeutic Area Lead, as well as other individuals within Medical Affairs and other functional areas within J&J, as necessary, to facilitate research and expanding the knowledge of J&J products for autoimmune diseases
• Provide subject matter expertise and function as US medical representative with internal stakeholders across multiple functional areas including marketing and sales, health economics and outcomes research, MSLs, and medical information.
• Develop and execute Medical Affairs sponsored/supported Phase IIIb/IV trials, registries, real-world evidence, and collaborations by leading study design, protocol development, analysis plan development, and providing overall trial leadership (including execution, monitoring, supervision, compliance, and risk identification/ mitigation). This requires close partnership with a matrixed team inside and outside of Medical Affairs (e.g. Clinical Scientists, Program Management, Biostats, Post-Approval Delivery Unit, Regulatory Affairs, Quality, Medical Monitor, external investigators/Key Opinion Leaders).
• Write as well as provide editorial comments for Phase IIIb/IV clinical study reports, abstracts and manuscripts related to J&J supported and sponsored studies.
• Contribute to the preparation of regulatory submissions and interactions with Health Authorities (particularly the FDA) and help to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods.
• Provide US medical input to Research & Development (R&D), including input into design of R&D clinical trials, presentations and publications.
• Contribute to US Autoantibody Medical Affairs strategy, and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Autoantibody products/indications, working cross-functionally with partners within the Autoantibody IET, including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Strategic Customer Group, Marketing brand teams, as well as potentially Autoantibody Disease Area Stronghold, R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the Autoantibody TA Strategy for establishing access plans for and progress and outcomes for evidence generation activities and dissemination plans.
• Contribute to and potentially lead (as the Integrated Evidence Team Leader) the cross-functional team to develop and maintain a current, strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline products/indications. Support payer-related materials and data needs to scientifically support market access efforts.
• Collaborate with external investigators and thought leaders; serve as a liaison between company and clinical investigators and thought leaders, and develop credible relationships with thought leaders, medical directors, key regulatory officials, medical societies and patient advocacy organizations.
• Review and evaluate Investigator-Initiated Study concepts, champion prioritized concepts through appropriate review, approval, & funding, and monitor study progress/milestones.
• 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.

Qualifications / Requirements:

• MD, DO, PhD or PharmD degree is required
• At least 8-10 years total healthcare related experience (academic clinical research, clinical practice, and/or pharmaceutical industry) with at least 2 years of experience with clinical study, registry, or real-word evidence, prior commercial/medical launch experience is preferred
• Pharma industry experience is highly preferred; Medical Affairs experience is a strong asset
• Experience in clinical trial design (Phase IIIb & IV) and clinical data interpretation is required
• Prior experience in clinical research and exposure to industry partnered activities are strongly preferred
• Experience in scientific investigation into mechanisms of autoimmune/alloimmune disease preferred
• Excellent attention to detail and organization skills are vital for this position
• Experience interacting with health care professionals and other thought leaders is a strong asset
• Evidence of strong scientific writing skills and analytical thinking is essential
• Ability to work in a matrix environment is essential for success in this role
• Up 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