Associate Medical Director, US Medical Affairs, Dermatology

About the role

The Associate Medical Director, US Medical Affairs - Dermatology will report to the Head (Senior Director), Dermatology, US Medical Affairs - Immunology, and be an important member of the Dermatology TA team. They will work closely with the other Dermatology Medical Directors (and Associate 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 supporting Immunology and Dermatology within the Johnson & Johnson organization.

Responsibilities

• Contributes to US Derm Medical Affairs strategy and will actively contribute to one or more integrated evidence teams (IETs) for approved and pipeline Dermatology products/indications, working cross-functionally with partners within the IETs, including Medical Science Liaison (MSL) team leaders, RWV&E, Field V&E, SCG, Marketing brand teams, as well as potentially Derm Disease Area Stronghold (DAS), R&D, Global Medical Affairs, (MSL) and Global Commercial partners to support execution of the TA Strategy for establishing access as well as plans for evidence generation and dissemination plans.
• Supports payer-related materials and data needs to scientifically support market access efforts.
• Contributes as a subject matter expert on analysis of key data in support of US Immunology for approved or planned therapies and indications, partnering particularly with respective marketing brand teams (as well as other commercial and IET partners, including RWVE, SCG, V&E Field and Med Info and other CAC partners).
• Develops and maintains a current, strategically aligned and annually updated Integrated Evidence Generation Plan (IEGP) for approved and pipeline Derm products/indications.
• Contributes to or leads the development of abstracts and manuscripts related to J&J supported and sponsored studies, with a focus on efficacy, outcomes, and safety/adverse event analyses.
• May serve as the Study Responsible Physician (SRP) or Study Responsible Scientist (SRS) (depending on terminal degrees) for one or more studies, responsible for the development and execution of these Medical Affairs sponsored and supported clinical programs for company products in the TA, with mentorship and supervision.
• Partners with individuals in TA team 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 (and support audits, as needed).
• Prepares regulatory submissions and interacts with Health Authorities (and particularly the US FDA) to ensure regulatory post-marketing commitments are efficiently satisfied with cost-effective, efficient, and scientifically rigorous methods.
• Builds and manages effective relationships with key opinion leaders and investigators related to Medical Affairs studies and strategic initiatives.

Requirements

• Bachelor’s degree required / PharmD, PhD, MD/DO degree preferred; NP/PA considered
• At least 1.5 years of pharmaceutical industry experience preferred and/or at least 5 years post-graduate clinical medical practice which may include research experience (clinical studies, registries, epidemiology or health outcomes)
• Strong organizational, written, and verbal communication skills, including proficiency in effective and impactful oral presentations
• Strong time management skills with the ability to be accountable for deliverables and timelines
• 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
• Energy and enthusiasm, leadership skills and potential, and the ability and desire to embrace building new expertise are essential
• Proficiency in English is necessary

Qualifications

• Experience in dermatology
• Experience with the planning and execution/writing of regulatory submissions, protocols, and/or scientific manuscripts
• Experience with data analysis and review, and/or clinical study execution as either an investigator or a medical monitor or clinical scientist
• Experience with the clinical use or clinical study of immunologic biologics and small molecules