Senior Director, Global Medical Affairs - GI Oncology

The Opportunity:

Reporting to the GI Tumors Medical Affairs Strategy Lead, the Senior Director, Global Medical Affairs, will be responsible for developing and executing the Global Medical Affairs (GMA) strategy and tactical plans with a focus on launch readiness, launch implementation and life cycle management for an individual asset.

The successful candidate will have a proven track record of developing and driving medical strategies with a focus on effectively communicating key scientific data through publications, medical information, medical communications, and congress activities. The successful candidate will also have experience gathering and analyzing insights through Advisory Boards, Key Opinion Leader (KOL) engagements and interaction with local/regional medical teams and translating those insights into tactics that optimize asset utilization and impact the drug lifecycle.

This role requires close collaboration with cross-functional counterparts across Development, Research and Commercial as well as other internal partners, to design and implement a comprehensive medical affairs strategy for assets in the GI space, with focus on PDAC and CRC.

Key responsibilities:  

• Develops and executes the GMA strategy and medical objectives including activities related to scientific engagement and communication, evidence generation, internal education, and patient advocacy.

• Develops and executes a Health Care Professional (HCP) engagement strategy to gather insights to shape internal programs.

• Acts as the medical representative on cross-functional teams.

• Serves as a therapeutic area content expert.

• Participates in the Global Medical Affairs Team (GMAT) to execute medical strategies, contribute to the operations and oversight of medical activities, and work cross-functionally to support associated pre-launch activities.

• Supports the execution of routine gap assessments leading to the development/refinement of publication strategy, evidence generation plans, and tactical plan as part of the overall GMA plan.

• Provides medical leadership in scientific engagement activities with key external stakeholders through organizing and leading advisory boards, studies investigator interactions, congress activities, and peer-to-peer discussions with the goal of communicating scientific insights to internal teams to drive strategy.

• Communicates clinical and scientific data to KOLs and other healthcare professionals through presentations, educational programs, and scientific discussions.

• Represents various medical affairs functions in cross-functional strategy team meetings including Clinical and Safety sub-teams, Global Brand Team, Global Product Team, Patient Advocacy, Market Access, and other cross-functional strategic discussions.

• Works closely with the Clinical and MSL teams to provide enrollment, scientific, and engagement support to ensure clinical trials meet study timelines.

• Partners with RWE strategy and Biomarker/CDx teams on related integrated evidence generation strategies and activities as part of the GMA Plan.

• Works with the Patient Advocacy and Grants teams to incorporate the patient voice and define external medical education strategies for independent grants, respectively.

• Provides medical support for scientific symposia and medical congresses and collaborate across GMA functions to develop, review, and align on key scientific communication points and medical information response documents within legal and compliance guidelines.

• Supports the review and approval of abstracts, manuscripts, corporate communications, and other data disclosure documents as well as internal stakeholder medical education activities related to the compound data and related competitor data.

• Collaborates with stakeholders across the organization, including, but not limited to, Clinical Development and Operations, Commercial Operations, Program Management, Business Development, Regulatory, Safety, and Compliance teams.

Required Skills, Experience and Education:

• An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical or scientific area is required.

• 15+ years of relevant experience in Medical Affairs within the biotech and/or pharmaceutical industry ( local, regional, and global levels) and/or prior clinical oncology practice.

• Strong scientific background in oncology, with preferred experience in GI cancers, and ability to effectively analyze, synthesize, and communicate complex scientific information.

• Direct, hands-on experience executing activities across key medical affairs functions, including training, medical communications, medical information, expanded access programs, evidence generation tactics and publications.

• Proven track record of clinical trial support including protocol development and review, site selection and enrollment support, and data analysis.

• Excellent interpersonal, written, and presentation skills with the ability to effectively communicate complex scientific data with a strong point of view to diverse audiences.

• Ability to thrive in a fast-paced, dynamic environment, managing multiple priorities independently with limited supervision.

• Ability to travel to Redwood City headquarters and professional conferences (30 - 40%).

• Strong networking skills with deep, existing relationships with GI cancer healthcare professionals, including global key opinion leaders.

Preferred Skills:

• Experience in global product launches including support of integrated brand plan ideation, regulatory submissions, reimbursement, and label development.

• Experience in guideline submissions (e.g. NCCN) and engagements with global health authorities preferred. 

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