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The Global Medical Affairs Leader (GMAL) for erdafitinib will be responsible for leading the clinical-commercial optimization for erdafitinib product development and life cycle management strategies and plans. S/he will partner closely with the GMA Operations Leader, Regional Medical TA/product leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans.
The erdafitinib GMAL will be an integral member of the late stage development Compound Development Teams for erdafitinib. In addition s/he will participate on the Global Commercial Team and also as an ad hoc member of the clinical team. The erdafitinib GMAL will also be a core member of the erdafitinib SMT. The erdafitinib 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 GMAL will be accountable for the 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 GMAL will also be responsible for facilitating and ensuring a consistent approach to global late stage Medical Affairs programs/activities globally.
Responsibilities include: Develop global medical affairs strategy and plan for the compound based on prioritized regional needs. In addition, partner closely with the Vice President of Global Medical Affairs and other GMALs to ensure one franchise strategy. Work with the CDTs 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 GMAL will be an active member of the core product CDTs 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. Synchronize input and output of the Med Affairs plan with the strategic and business plan calendars. Lead global publications planning process oversight (with vendor support) including manuscripts, abstracts, posters and papers as well as pre-launch global KOL communications & speaker development. Review of manuscripts to ensure alignment with strategy and effective communication/presentation in internal and external audiences (e.g. Symposia). The GMAL is responsible for review and approval of proposed evidence generation activities within Medical Affairs for oncology products. 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 or PhD), with experience in oncology required.
A minimum of 2 years working in Medical Affairs with 6+ years of combined relevant experience in a medical/clinical environment, scientific function in the pharmaceutical industry is required.
Knowledge of oncology products in bladder cancer and lung cancer strongly 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.
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.
Act as a medical spokesperson for external audiences.
Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders. Proven business understanding.
A minimum of 30% international travel is required.
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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