Senior Director, US Medical Affairs Strategy Lead - GI

The Opportunity:

Reporting to the VP US Medical Affairs Strategy Lead, the Senior Director, US Medical Affairs, will be responsible for developing and executing the US Medical Affairs (USMA) strategy and tactical plans with a focus on launch readiness and life cycle management for an individual asset in gastrointestinal (GI). The successful candidate will have a proven track record of developing and driving medical strategy with a focus on effectively communicating key scientific data through publications, medical information, medical communications, and congress activities as well as gathering insights through Advisory Boards and Key Opinion Leader (KOL) engagements. They must work collaboratively with cross-functional counterparts in Development, Research and Commercial as well as other partners in the organization to design and implement a comprehensive GI strategy.

Key responsibilities: 

• Develops and executes the USMA 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 inform the medical strategy.

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

• Serves as a therapeutic area content expert.

• Participates in the Global Medical Affairs Team (GMAT) and US Medical Affairs Team (USMAT) 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 a publication strategy, an evidence generation plan, and tactical plan as part of the overall USMA 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 US 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 USMA 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 medical congresses and collaborates across US and Global 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/scientific area is required.

• 15+ years of relevant experience in biotech or pharmaceutical industry focused on Medical Affairs, with cross-functional headquarter experience and on field-based teams or equivalent clinical and or academic/research experience.

• Must have a strong scientific background in GI cancer with a good understanding of biomarker-driven disease and ability to effectively analyze, synthesize, and communicate complex scientific information.

• Direct, hands-on experience executing the activities of various functions within medical affairs (training, medical communications, medical information, expanded access programs, evidence generation, publications).

• Proven track record of clinical trial support including protocol development/review, site selection support, 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.

• Thrives in fast-paced, dynamic environment and ability to multi-task independently with limited supervision.

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

• Strong networking skills with deep existing relationships with GI cancer healthcare professionals including US top key opinion leaders required.

Preferred Skills:

• Experience in US 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 US clinical practice guidelines preferred.

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