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About the job

The Role

The Executive Medical Director, Global Clinical Development will provide clinical and scientific leadership for Agenus’ oncology development programs, with a particular focus on botensilimab (BOT) plus balstilimab (BAL), our next-generation CTLA-4/PD-1 immunotherapy combination.

With BOT+BAL advancing through Phase 2 and registrational Phase 3 development, including in microsatellite stable colorectal cancer (MSS CRC), this individual will play a key role in the design, execution, and interpretation of global oncology clinical trials. The Executive Medical Director will work closely with senior Clinical Development leadership and cross-functional partners to translate emerging clinical, biomarker, and safety data into development decisions and ensure high-quality execution of the clinical program.

This is a hands-on leadership role for an experienced oncology drug developer who can operate effectively in a fast-paced biotechnology environment, move comfortably between strategy and execution, and personally drive critical clinical development work when needed.

In The Role You Will

Clinical Development & Study Leadership

Provide clinical and scientific leadership for global oncology studies, with particular emphasis on Phase 2 and Phase 3 development of BOT+BAL.

Lead the design, execution, and interpretation of clinical trials in solid tumors, including MSS colorectal cancer and other priority indications.

Develop study concepts, protocols, clinical development plans, and supporting scientific rationale in collaboration with cross-functional partners.

Translate emerging efficacy, safety, biomarker, and competitive data into recommendations regarding study design, patient populations, endpoints, combination strategies, and future development opportunities.

Drive clinical development activities from protocol development and study initiation through data analysis, database lock, clinical study report, and regulatory submission.

Identify clinical and scientific issues that may affect program execution and proactively develop solutions in partnership with Clinical Operations, Biometrics, Regulatory Affairs, Translational Medicine, and Pharmacovigilance.

Support indication and lifecycle development strategy as clinical data and the competitive treatment landscape evolve.

Oncology & Immuno-Oncology Development

Apply deep knowledge of oncology drug development to the advancement of BOT+BAL and other Agenus oncology programs.

Bring a strong understanding of immuno-oncology and the evolving treatment landscape, including checkpoint inhibitors and immune-based combination strategies.

Integrate clinical, translational, and biomarker findings to inform patient selection, study design, and development strategy.

Maintain a strong understanding of the colorectal cancer treatment landscape, particularly MSS CRC, and emerging therapeutic approaches relevant to Agenus programs.

Evaluate external clinical and scientific data and competitive intelligence to identify implications and opportunities for the development program.

Clinical Data & Scientific Leadership

Lead ongoing review, interpretation, and communication of clinical trial data, identifying emerging efficacy, safety, and biomarker trends that may affect study or program decisions.

Work closely with Biometrics, Data Management, and Clinical Operations to ensure appropriate data collection, data quality, analysis, and interpretation.

Develop clinical data review strategies and ensure emerging findings are translated into clear scientific conclusions and recommendations.

Present clinical data, development recommendations, program risks, and key decisions to internal leadership and cross-functional teams.

Apply sound medical and scientific judgment when data are incomplete, evolving, or potentially conflicting.

Regulatory & Development Execution

Author and/or provide substantive input into key clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, briefing documents, safety documents, and clinical sections of regulatory submissions.

Partner with Regulatory Affairs in preparation for interactions with FDA, EMA, and other global health authorities.

Provide clinical and scientific support for regulatory discussions related to Phase 2, Phase 3, registrational development, and potential marketing applications.

Contribute to responses to health authority questions and help develop the clinical and scientific rationale supporting key development decisions.

Participate in regulatory meetings and represent the clinical development perspective when appropriate.

Cross-Functional & External Leadership

Provide clinical leadership across multidisciplinary teams including Clinical Operations, Regulatory Affairs, Translational Medicine, Pharmacovigilance, Biometrics, CMC, and other functions.

Work closely with Clinical Operations on investigator and site engagement, study execution, enrollment strategy, and resolution of clinical issues affecting trial conduct.

Build productive relationships with investigators, scientific experts, and key opinion leaders in oncology.

Engage KOLs and investigators to obtain scientific input on study design, patient populations, evolving treatment paradigms, and interpretation of clinical data.

Participate in investigator meetings, advisory boards, scientific conferences, and other external forums.

Collaborate effectively with external partners, CROs, vendors, and academic investigators supporting Agenus clinical programs.

Leadership & Working Style

Operate as a hands-on clinical development leader who can independently drive complex work while collaborating closely with senior leadership and cross-functional partners.

Take personal ownership of critical clinical development deliverables rather than relying solely on functional infrastructure or external partners.

Provide mentorship and clinical guidance to Clinical Development team members.

Communicate complex clinical and scientific issues clearly and effectively to both technical and nontechnical stakeholders.

Work effectively in a lean, entrepreneurial environment where priorities may evolve quickly and leaders are expected to both set direction and execute.

Demonstrate sound judgment, urgency, accountability, and the ability to make decisions with incomplete or evolving information.

Qualifications

MD or international equivalent with 8+ years of biotechnology and/or pharmaceutical industry clinical development experience.

Significant sponsor-side oncology drug development experience, particularly in solid tumors.

Experience in immuno-oncology is strongly preferred, including experience with checkpoint inhibitors, CTLA-4, PD-1/PD-L1, or other immune-based therapies.

Experience in colorectal cancer or gastrointestinal oncology is highly desirable.

Demonstrated experience leading Phase 2 and Phase 3 oncology clinical trials, including pivotal or registration-enabling studies.

Experience contributing to oncology development programs from study design through execution, data analysis, regulatory interactions, and submission activities.

Strong understanding of global oncology drug development and the scientific, clinical, regulatory, and operational requirements for advancing programs through late-stage development.

Experience working directly with FDA and/or other global health authorities on clinical development programs.

Demonstrated ability to author or substantively contribute to protocols, clinical study reports, briefing documents, investigator brochures, and clinical sections of regulatory submissions.

Strong experience interpreting efficacy, safety, and biomarker data and translating findings into clinical development decisions.

Experience collaborating with investigators and oncology KOLs on clinical development strategy and study execution.

Strong cross-functional leadership skills with the ability to drive decisions and execution across Clinical Operations, Regulatory Affairs, Biometrics, Translational Medicine, Pharmacovigilance, and other functions.

Excellent written and verbal communication skills and the ability to communicate complex scientific and clinical concepts clearly.

Strategic and scientifically rigorous while remaining highly hands-on and execution focused.

Comfortable operating independently in a lean, fast-paced biotechnology environment with limited infrastructure and changing priorities.

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