Johnson & Johnson Careers
Global Medical Affairs Leader, Retinal Diseases
Requisition ID: 1047190402
Janssen Pharmaceuticals is recruiting for a Global Medical Affairs Leader – Retinal Diseases to be located in Raritan, NJ
The Global Medical Affairs Leader (GMAL) Retinal Diseases will be responsible for leading the clinical optimization for the product development and life cycle management strategies and plans for multiple products. 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 GMAL will be an integral member of the late stage development Compound Development Teams. In addition, s/he will participate on the Global Commercial Team and as an ad hoc member of the clinical team. The GMAL will also be a core member of the Safety Management Team. The 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 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.
- Develop global medical affairs strategy and plan for the compound based on prioritized regional needs.
- Partner closely with the Vice President of Global Medical Affairs and other GMAF Leaders 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 for this late stage asset from phase IIa through phase IV.
- Be responsible for medical activities of new indications for this product including Therapeutic Area global advisory boards, medical symposia and congress activities, in collaboration with functional leads of regional activity in these areas.
- The Global Medical Affairs Medical Leader 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 GMAF Leader will be responsible for review and approval of proposed evidence generation activities within Medical Affairs for [TA] products.
- Responsible to ensure all global activities following J&J Compliance principles, e.g. Health Care Compliance, etc.
- A minimum of a Ph.D., MD or DO is required.
- Experience in the ophthalmic therapeutic area is required
- Prior experience in a Global or Regional Medical Affairs role is 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
- A demonstrated track record leading highly matrixed, cross-functional work teams or similar experience comprised of high-level managers and executives is preferred
- Proven ability to partner cross culturally/regionally is preferred
- In-depth knowledge of clinical methodology, clinical data reviews and analysis is preferred
- Excellent knowledge of study execution, benefit risk management and life-cycle management are preferred
- Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues is required
- Experience in developing and managing strategic relationships with medical experts/opinion leaders is required.
- This position will be located in Raritan, NJ and will require up to 30% domestic and international travel.
United States-New Jersey-Raritan-
Janssen Global Services, LLC (6085)