SENIOR GLOBAL MEDICAL AFFAIRS LEADER

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs – MD

Job Category:

People Leader

All Job Posting Locations:

US065 NJ Raritan - 700 Route 202 S

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.  Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

The Senior Global Medical Affairs Leader (Sr. GMAL) for oncology pre-approval access will be responsible for leading the overall strategic development, planning and execution of Johnson & Johnson Innovative Medicine pre-approval access programs (PAA) worldwide across the oncology portfolio. This individual will collaborate with Global Medical Affairs Leaders (GMAL) in each asset team, Global Head Evidence Generation and Study Execution, VPs of Oncology Global MAF for Hematology and Solid Tumors, External Scientific Engagement Leaders, Compound Development Team Leaders (CDTL) and senior R&D leaders across the oncology TA to drive the strategy and execution of pre-approval access programs. This individual will also serve as a senior leader collaborating with leadership partners in Patient Strategies & Solutions, Legal, and the Medical Affairs Delivery Unit.

The Sr GMAL will lead the creation and implementation of all global oncology PAA programs working with R&D, medical affairs, market access, real world evidence, regulatory, CMC, pharmacovigilance, and clinical operations. They will work closing with Global MAF and R&D teams to develop anticipated pre-approval access plans, developing a comprehensive assessment of needs and coordinate with Clinical Supply to ensure appropriate drug availability. This individual would be responsible for the delivery and alignment of PAA strategic plans in collaboration with regional & country medical leads. They would also draft treatment guidelines in partnership for expanded access clinical trial programs, coordinate with regulatory medical writing to facilitate development of clinical trial protocol and country specific access programs (e.g. Brazil, France). This individual would also lead the development of any evidence generation plans from pre-approval access programs, along with review and approval of any peer-review publications or presentations of clinical data from these programs.

The Sr. GMAL would attend CDTs on an ad hoc basis as needed to support the development of pre-approval access programs, along with Safety Management Teams (SMT) regarding safety related topics. They would be responsible for a worldwide plan that is regularly updated and reviewed with the Oncology Global MAF Leadership Team, R&D Leadership, MA DU and Patient Strategies and Solutions. They would also take the lead in presenting to the Compac committee, preparing and reviewing materials and ensuring a consistent equitable approach across J&J oncology assets.

The Sr GMAL will also take on additional responsibilities outside and beyond pre-approval access. One of these assignment areas will be releated to clinical strategies and approaches to support medical use and adoption in community treatment settings. They will work to partner with internal and external stakeholders to understand barriers to medical use with recommendations and action plans to support oncology TA assets to overcome community access. They will also take on ad hoc special projects from the VP Oncology Global Medical Affairs.

Job Qualifications

This position requires a medical degree with experience in oncology strongly preferred, along with a broad set of clinical experiences around patient treatment and managemen