Associate Director, Global Medical Affairs Lead (Solid Tumor

Overview

The Associate Director is a core member of the Global Medical Affairs (GMA) Solid Tumors team within the CDMA, R&D Organization, and serves as the in-house clinical and scientific expert for one or more assets and disease areas. The role holds medical accountability for the company's externally-conducted research portfolio, including specific investigator-sponsored trials (ISTs), collaborative and consortium studies, and translational collaborations;

and owns the evidence strategy required to achieve inclusion and favorable positioning of company data in clinical practice guidelines and drug compendia.

• Own assigned activities of determined ISTs and research collaborations including scientific review, protocol refinement, contracting and budget support, milestone tracking, data delivery, and publication.
• Serve as the medical/scientific point of contact for investigators and collaborating institutions, ensuring sites understand and adhere to the clinical and scientific nuances of the protocol: eligibility intent, assessment schedules, biomarker and specimen handling, endpoint definitions, and safety reporting expectations.
• Proactively shape the external research portfolio: define the questions the company needs answered externally (populations, sequences, combinations, real-world settings, underrepresented subgroups) and solicit proposals accordingly.
• Lead the setup, scientific discussion, design, and implementation of clinical and translational protocols within collaborative frameworks, including endpoint selection, statistical considerations, and biomarker/translational plans.
• Translate strategic scientific objectives into executable study designs for complex trials — identifying optimal development pathways, expansion opportunities, and differentiating positioning that maximizes the asset's clinical and commercial value.
• Act as Medical Study Lead for designated GMA-sponsored studies (tumor-, asset-, or indication-specific), with accountability for medical monitoring input, protocol amendments, data review, interpretation, and reporting.
• Partner with Translational Medicine and Clinical Sciences (Biostatistics, Clinical Pharmacology, etc) to design and execute non-clinical and translational data generation strategies where program needs require it.
• Identify and engage qualified investigators and sites with demonstrated recruitment capability, relevant patient populations, and translational capacity.
• Own the guideline strategy for assigned assets: map current guideline language, define the target language, and identify the specific evidentiary gaps that stand between the two.
• Build and maintain a guideline evidence roadmap that sequences pivotal, supportive, IST, and RWE datasets against published panel review cycles, so that peer-reviewed publication and congress presentation of each dataset land ahead of the relevant review window.
• Prepare, coordinate, and submit formal information requests and data submissions to guidelines and compendia bodies, working through the designated non-promotional submission channels and in partnership with Regulatory Affairs, Legal/Compliance, Publications. All guideline body interactions are conducted exclusively through formal, documented, non-promotional submission processes. Direct advocacy toward individual panel members is out of scope and expressly excluded from this role's activities.
• Ensure every submission package is complete and defensible: full publications, congress abstracts and presentations, prescribing information, and a clear articulation of the clinical question addressed, the strength of evidence, and the proposed category of recommendation and evidence.
• Monitor guideline versioning across all relevant assets and competitors; analyze changes for strategic implications and communicate them to Medical, Commercial, Access, and Development leadership with a recommended response.
• Anticipate and address the evidentiary objections a panel is most likely to raise (sample size, single-arm design, cross-trial comparison, subgroup analyses, generalizability) and build the supporting evidence to close them.
• Conduct continuous review and…