Employment Type

: Full-Time


: Healthcare - Physician

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The Global MedicalAffairs Leader (GMAL) for erdafitinib will be responsible for leading theclinical-commercial optimization for erdafitinib product development and lifecycle management strategies and plans. S/he will partner closely with the GMAOperations Leader, Regional Medical TA/product leaders and Clinical DevelopmentLeader to develop an integrated global medical affairs perspectives, strategiesand plans.

The erdafitinib GMALwill be an integral member of the late stage development Compound DevelopmentTeams for erdafitinib.In addition s/he will participate on the GlobalCommercial Team and also as an ad hoc member of the clinical team. The erdafitinibGMAL will also be a core member of the erdafitinib SMT. The erdafitinib GMALwill be responsible for the development of the global medical affairs plan thatreflects prioritized regional needs, which are included in the overall CompoundDevelopment Plan. In addition, the GMAL will be accountable for the leading theglobal publication plans, global opinion leader relations, global medicaleducation (including symposia, speaker training) and global advisory boards forproducts starting in early development (phase IIA) and through launch of majorlife cycle management initiatives. The GMAL will also be responsible forfacilitating and ensuring a consistent approach to global late stage MedicalAffairs programs/activities globally.

Responsibilitiesinclude: Develop global medical affairs strategy and plan for the compoundbased on prioritized regional needs. In addition, partner closely with the VicePresident of Global Medical Affairs and other GMALs to ensure one franchisestrategy. Work with the CDTs to ensure integration with the overall globalcompound strategy, resulting in one global R&D and Medical Affairs compounddevelopment plan, inclusive of developing a Target Product Profile representingmedical affairs global and regional value needs. Provide single MedicalAffairs voice into the creation of compound development and LCM strategies,plans and trial design from phase IIa through phase IV. Responsible forpre-launch medical activities including product/ Therapeutic Area globaladvisory boards, medical symposia and congress activities, in collaborationwith functional leads of regional activity in these areas.

The GMAL will be anactive member of the core product CDTs and will lead a global Medical AffairsTeam consisting of regionally designated Therapeutic Area Medical AffairsLeaders to create one medical affairs perspective and one \"unified\"voice on the CDT. They will collaborate closely with the regional medicalaffairs representatives to develop integrated global medical affairs strategiesand plans and maintain open, two-way communication to ensure regional medicalaffairs is up to date on all plans, progress and decisions. Synchronizeinput and output of the Med Affairs plan with the strategic and business plancalendars. Lead global publications planning process oversight (with vendorsupport) including manuscripts, abstracts, posters and papers as well aspre-launch global KOL communications & speaker development. Review ofmanuscripts to ensure alignment with strategy and effectivecommunication/presentation in internal and external audiences (e.g.Symposia). The GMAL is responsible for review and approval of proposedevidence generation activities within Medical Affairs for oncology products.Responsible to ensure all global activities follow J&J Complianceprinciples, e.g. Health Care Compliance, etc.

Job Qualifications
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.

Primary Location
United States-New Jersey-Raritan-
Other Locations
North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House
Janssen Global Services, LLC (6085)
Job Function
Medical Affairs
Requisition ID

Associated topics: ancmg, aoa, breast, cancer, hem onc, lah, oncology, palliative, radiation, thedacare

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