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The Senior Global Medical Affairs Leader (Sr. GMAL) for amivantamab will be responsible for leading the clinical-commercial optimization for the amivantamab product development and life cycle management strategies and plans. They will partner closely with the Strategy and Executions Leader, Regional Medical TA/product leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans. This position reports to the Global Head of Lung Cancer and Targeted Therapies, who is responsible for all lung cancer and targeted therapies.
The Sr. GMAL will be an integral member of the late stage development Compound Development Teams (CDT). In addition they will participate on the Global Commercial Team and also as an ad hoc member of the clinical team. The Sr. GMAL will also be a core member of the Safety Management Team (SMT). The Sr. GMAL will be responsible for the development of the global medical affairs plan that reflects prioritized regional needs, which are included in the overall Compound Development Plan. In addition, the Sr. GMAL will be accountable for leading the global publication plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for products starting in early development (phase IIA) and through launch of major life cycle management initiatives. The Sr. GMAL will also be responsible for facilitating and ensuring a consistent approach to global late stage Medical Affairs programs/activities worldwide.
Responsibilities include: Develop global medical affairs strategy and plan for the compound based on prioritized regional needs, partnering with Global Medical Affairs colleagues including the External Scientific Engagement Leader, Global Head of Patient Advoacy and Early Access and Global Head of Worldwide Evidence Generation. In addition, they will work closely on overall asset strategy with the Global Head of Lung Cancer and Targeted Therapies and other GMALs to ensure one franchise strategy. Work with the CDT to ensure 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 single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV. Responsible for pre-launch medical activities including product/ Therapeutic Area global advisory boards, medical symposia and congress activities, in collaboration with functional leads of regional activity in these areas.
The Sr. GMAL will be an active member of the core product CDT and will lead a global Medical Affairs Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one "unified" voice on the CDT. They will 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 is up to date on all plans, progress and decisions. The Sr. GMAL will also chair the global review committee to oversee investigator initiated studies and extramural research. The Sr. GMAL will synchronize input and output of the Med Affairs plan with the strategic and business plan calendars. Lead the global publication plan strategy in concert with the Strategy and Execution leader, reviewing manuscripts to ensure alignment with strategy and effective communication/presentation in internal and external audiences (e.g. Symposia). The Sr. GMAL is responsible for review and approval of proposed evidence generation activities within Medical Affairs amivantamab. Responsible to ensure all global activities follow J&J Compliance principles, e.g. Health Care Compliance, etc.
This position requires a minimum of an advanced degree (e.g. MD, PhD or master level), with experience in oncology required. A minimum of 5 years working in Medical Affairs with 10+ years of combined relevant experience in a medical/clinical environment, scientific function in the pharmaceutical industry is required.
Knowledge of lung cancer is required with experience on CRC and GI malignancies preferred. A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level managers and executives is required. A demonstrated track record of success within Medical Affairs, clinical environment and/or scientific function required. Demonstrated clinical or outcomes research publications where the candidate has been pivotal in the creation of the work. Global mindset required, with direct experience in multiple markets, proven ability to partner cross culturally/regionally is preferred as well as an in-depth knowledge of study methodology, study data reviews and analysis. In this position a successful candidate should have excellent knowledge of study execution, benefit risk management and lifecycle management. Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues within the TA. Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders. Proven business understanding. This role will have up to 20% international travel as part of the role.
This position may require up to 25% domestic and international travel depending on business needs.
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.