Janssen Global Services, L.L.C. (JGS) a Johnson and Johnson Company is hiring a Global Medical Affair Leader (Senior Director) - Oncology/Hematology to sit in Raritan, NJ.
Janssen Global Services, LLC encompasses groups that provide leadership across critical business areas for Janssen including, Global Commercial Strategy Organization; Global Pharmaceuticals Communication and Public Affairs; U.S. Pharmaceuticals Procurement Group; and Pharmaceuticals Group Business Development.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
- The Global Medical Affairs Leader (GMAL) is responsible for supporting the development and execution of integrated data generation strategies and plans for our GU oncology assets including niraparib, erdafitinib, and Listeria vaccine immunotherapy.
- The GMAL for solid tumors will work closely with both an Oncology GMA Operations Leader and the GMAL for prostate cancer to lead the clinical-commercial optimization of their assigned products, from proof of concept through life cycle management, in collaboration with the respective global commercial and clinical leaders as well as the regional Medical Affairs product leaders.
- The GMAL will be an integral member of the niraparib, erdafitinib, and Listeria vaccine Compound Development Teams.
- In addition he/she will participate on the Global Commercial Team and be an ad hoc member of the clinical team for their respective products.
- The GMAL will be responsible for development of the global medical affairs plans that address prioritized regional needs/data gaps, and which support a differentiated product profile to optimize market access and reimbursement.
- 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 products starting in early development (phase IIA) and through launch of major life cycle management initiatives.
- The GMAL in collaboration with the Oncology GMA Operations Leader will also be responsible for facilitating and ensuring a consistent approach is utilized across their Global Medical Affairs programs and activities in compliance with SOPs.
- Develop global medical affairs strategy and plans for the assigned compounds based on data gaps and prioritized regional needs and supported by Real World Evidence.
- Working with the CDT as well as the Global Clinical, Commercial, and Market Access Teams to ensure integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, to support a differentiated Target Product Profile and compelling value proposition.
- Provide consolidated regional input with a single Medical Affairs voice into the creation of compound development and LCM strategies, that support a strong value proposition for optimizing reimbursement and utilization.
- Responsible for pre-launch medical activities including product/disease 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 TA Team consisting of regionally designated Therapeutic Area 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 the regional medical affairs teams are up to date on disease knowledge and emerging data (including data on competitive programs), as well as progress on milestones and key 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 (eg. Symposia).
- The GMAL is responsible for review and approval of proposed data generation activities within Medical Affairs for Oncology products. Responsible to ensure all global activities follow J&J Compliance principles, eg. Health Care Compliance, etc.
- This position requires a minimum of an MD or PhD degree, with a specialty in Oncology Clinical Research.
- A minimum of 6 or more years of combined relevant experience in a clinical research environment, scientific function in the pharmaceutical industry is required.
- Prior experience in an oncology medical affairs role is preferred.
- Knowledge of oncology products, both J&J and competitors, is required.
- 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 and/or clinical R&D required.
- Global mindset and direct experience in multiple markets, proven ability to partner cross culturally/regionally is preferred as well as in-depth knowledge of study methodology, 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.
- Proven ability to act as a medical spokesperson with strong communication skills for external audiences is required.
- Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders.
- A minimum of 30% international travel is required.
If you want to obtain oncology global experience with high visibility and impact, bid on this position today!Primary Location
United States-New Jersey-RaritanOther Locations
North America-United States-Pennsylvania-Spring HouseOrganization
Janssen Global Services, LLC (6085)Job Function
Clinical Research MDRequisition ID
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