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The Global Medical Affairs Leader (GMAL), Director, Dermatology, under the direction of the Vice President of Global Medical Affairs for Dermatology/Rheumatology, is responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans for the assigned compounds in clinical development for atopic dermatitis within the Immunology Therapeutic Area (TA). The GMAL will lead the Global Medical Affairs Team and partner closely with Regional Medical TA/product leaders to develop integrated Global Medical Affairs perspectives, strategies and plans for specified products, assets, and projects. The GMAL, will be a member of the Compound Development Teams (CDTs), the Safety Management Teams and Global Commercial Teams, as well as an ad hoc member of the Clinical Team and Global Market Access Team. The GMAL will be responsible for development of Global Medical Affairs plans that reflects prioritized regional needs and are included in the overall asset development plans. In addition, the GMAL will be accountable for the global publications plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for assets starting in early development (phase IIA) and through launch of major life cycle management initiatives (earlier or later as needed). The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally.

Key Responsibilities:
• Develop Global Medical Affairs strategy and plan for the assigned compounds based on prioritized regional needs.
• Working with the CDT ensures integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing Medical Affairs global and regional value needs.
• Provide a single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV.
• Be responsible for pre-launch Medical Affairs activities including product/TA global advisory boards, medical symposia and congress activities, and coordination of regional activity in these areas.
• Be an active member of the CDT and lead a Global Medical Affairs Team consisting of regionally designated TA Medical Affairs Leaders to create one Medical Affairs perspective and one "unified" voice on the CDT.
• Collaborate closely with the regional Medical Affairs representatives to develop integrated Global Medical Affairs strategies and plans and maintain open, two-way communication to ensure regional Medical Affairs partners are up to date on all plans, progress and decisions.
• Synchronize input and output of the Medical Affairs plan with the strategic and business plan calendars.
• Maintain responsibility for the development and execution of global publication plans as well as review and approval of publications for marketed products and specified compounds in clinical development.
• Lead the ReCAP process (review of all Medical Affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products.
• Support development of the Company risk management strategy and plan as well as author and review specific sections of the Periodic benefit-risk assessment report for compounds. Perform medical impact assessments as required.
• Maintain responsibility for ensuring that all global activities follow J&J Compliance principles (e.g. Health Care Compliance etc.)

Qualifications

• A minimum of a PharmD, PhD or MD degree (or equivalent) is required with specialty training and certification in dermatology preferred
• A minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required; at least three years in the Medical Affairs environment is highly desirable
• Extensive clinical and/or pharmaceutical experience in Immunology is required
• Experience in dermatology disease areas, particularly atopic dermatitis, and having an established network with medical experts/opinion leaders in dermatology are highly preferred
• Strategy development expertise is highly preferred
• A demonstrated record of success within Medical Affairs and/or Clinical R&D preferred
• In-depth knowledge of study methodology, study data reviews and analysis required
• Excellent knowledge of study execution, benefit risk management and regulatory affairs highly preferred
• Proven ability to function as a medical spokesperson for external audiences is required
• Strong experience developing and managing strategic relationships with medical experts/opinion leaders required
• Adaptability, flexibility, managing internal and external relationships, organization and project management competencies and skills are essential
• Global mindset with proven record to partner cross culturally and regionally is preferred
• Strong interpersonal skills, strong written and oral communication skills, both and collaboration and teaming skills are required
• Proven track record on ethics and Credo principles
• Approximately 25% or more travel in the US and internationally 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. Travel to nearby Springhouse, PA site is expected.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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