Job Description

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.

#LI-JW1