Medical Director, Dermatology- US Medical Affairs

About the role

We are searching for the best talent for Medical Director, Dermatology Medical Affairs within our US Immunology Medical Affairs organization located in Horsham, PA.

Responsibilities

• 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 (SRP) for select medical affairs trials.
• Contribute/lead the advancement of protocol development, medical / data monitoring, study operations, data analysis / reporting, writing of study reports and publications, as applicable.
• 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 Dermatology TA strategy across the asset, prioritizing key indications.
• 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).
• 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.
• Contribute to US Dermatology Medical Affairs strategy, and potentially leads one or more integrated evidence teams (IETs) for approved and pipeline Dermatology products/indications, working cross-functionally with partners within the Dermatology IET, including Medical Science Liaison (MSL) team leaders, Real World Value & Evidence, Strategic Customer Group, Marketing brand teams, as well as potentially Dermatology Disease Area Stronghold (DAS), R&D, Global Medical Affairs, MSL and Global Commercial partners to promote and execute the Dermatology 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.

Requirements

• MD/DO degree is required.
• At least 8-10 years total healthcare related experience (academic clinical research, clinical practice, and/or pharmaceutical industry).
• Pharma industry experience is required; Medical Affairs experience is a strong asset.
• Experience in dermatology.
• Experience in clinical trial design (Phase IIIb & IV) and clinical data interpretation is preferred.
• Prior experience in clinical research and exposure to industry partnered activities are strongly 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.