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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