The Role
The Executive Medical Director, Global Clinical Development will provide strategic and medical leadership for Agenus' global 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 into registrational Phase 3 development in MSS colon cancer and expanding patient access through authorized programs in Europe and globally, this is an opportunity to play a central role in shaping the next stage of a potentially transformative oncology program. This individual will serve as a senior clinical leader while remaining highly engaged in the medical monitoring and scientific oversight of clinical trials, bringing a hands-on approach, strong medical judgment, and the ability to translate emerging clinical data into clear development strategies and decisions.
In the role you will:
Global Clinical Development & Program Leadership
- Provide strategic and medical leadership for assigned global oncology development programs, driving clinical development strategy, study design, indication and patient population strategy, and key program decisions.
- Lead the development and execution of integrated clinical development plans spanning early- through late-stage and registrational development, ensuring individual studies support broader program, regulatory, and product objectives.
- Translate emerging efficacy, safety, biomarker, and competitive data into actionable development strategy, including recommendations regarding study design, patient selection, combination strategies, and future development opportunities.
- Provide clinical leadership for late-stage and registrational programs, including Phase 3 development and preparation for global regulatory submissions and potential marketing applications.
- Represent Clinical Development and assigned programs with senior leadership and governance committees, clearly communicating clinical strategy, emerging data, program risks, and recommendations to drive timely decision making.
- Serve as a visible scientific and clinical leader for assigned programs with investigators, KOLs, regulatory authorities, and external partners.
Medical Monitoring & Patient Safety
- Act as Medical Monitor for assigned clinical trial(s), providing medical oversight to ensure patient safety, protocol compliance, and scientific integrity throughout study conduct.
- Provide medical oversight for ongoing safety surveillance, including timely review and assessment of adverse events, protocol deviations, eligibility questions, and other medical issues arising during study conduct.
- Evaluate evolving clinical data in situations where information may be incomplete or ambiguous, applying sound medical judgment to make timely decisions while clearly communicating scientific rationale, differing viewpoints, risks, and recommendations to cross-functional stakeholders.
Clinical Development & Data Leadership
- Lead the ongoing review, curation, interpretation, and analysis of clinical trial data, ensuring data quality, completeness, consistency, and scientific integrity while identifying emerging efficacy and safety trends that inform development decisions.
- Develop and execute clinical data review plans and provide timely scientific interpretation of emerging data to internal teams and governance committees.
- Work closely with Clinical Operations, Data Management, and Biostatistics to optimize clinical data collection, CRF design, EDC functionality, data quality, and overall study execution.
Scientific & Regulatory Leadership
- Author and/or review key technical and clinical documents, including clinical study protocols, investigator brochures, clinical study reports, annual reports, safety documents, and clinical sections of regulatory submissions.
- Partner with Regulatory Affairs to define global regulatory strategy and represent the clinical development perspective in interactions with health authorities, including discussions supporting registrational development and BLA/MAA submissions.
- Participate in and prepare presentations for DSMBs, Steering Committees, Scientific Advisory Boards, investigator meetings, and other internal and external scientific forums.
- Assist in the preparation of abstracts, manuscripts, posters, and scientific presentations.
Cross-Functional Collaboration
- Partner with Clinical Operations in the selection of investigators, clinical sites, and vendors (including CROs) and be accountable for the scientific execution of clinical protocols.
- Coordinate scientific activities across Regulatory Affairs, Translational Medicine, Clinical Operations, Pharmacovigilance, Biometrics, and other internal stakeholders to ensure efficient execution of clinical programs.
- Provide clinical leadership across cross-functional program teams, driving alignment and accountability around development priorities, key decisions, timelines, and program risks.
External Engagement
- Build productive relationships with external scientific experts, investigators, and key opinion leaders.
- Establish credibility as a clinical and scientific leader with investigators and KOLs and effectively communicate the scientific rationale, clinical data, and development strategy for assigned programs.
Leadership & Working Style
- Operate as a senior clinical development leader with the ability to set direction, influence decisions, challenge assumptions, and drive alignment across multidisciplinary teams.
- Provide mentorship and clinical guidance to Clinical Development team members and contribute to building the capabilities of the broader organization.
- Work independently while contributing effectively within a collaborative, interdisciplinary team environment.
- Maintain flexibility to meet deadlines and respond effectively to changing priorities in a fast-paced development environment.
Qualifications
- MD or international equivalent with 8+ years of biotechnology and/or pharmaceutical industry clinical development experience, including significant experience in sponsor-side oncology drug development.
- Oncology drug development experience is required. Prior experience in immuno-oncology, immunotherapy, checkpoint inhibitors, or other immune-based therapies is strongly preferred.
- Experience leading global clinical development programs from early-phase development through late-stage and registrational studies, including Phase 3 trials and contributions to global regulatory submissions (e.g., BLA, NDA, or MAA).
- Experience taking ownership of a clinical development program from study design through database lock, clinical study report, regulatory submission, and health authority interactions, rather than isolated experience across multiple studies.
- Demonstrated ability to lead cross-functional clinical development teams and influence program strategy and decision making at the senior leadership level.
- Experience representing clinical programs with investigators, KOLs, health authorities, governance committees, and/or executive leadership.
- Broad and solid understanding of drug development, including preclinical research, clinical operations, regulatory affairs, pharmacovigilance, biometrics (biostatistics and data management), and drug supply.
- Hands-on experience reviewing, interpreting, and analyzing clinical trial data with accountability for the scientific quality, integrity, and communication of study results.
- Ability to understand, interpret, and communicate complex clinical information, literature, competitive intelligence, and evolving treatment paradigms to support robust clinical development strategies.
- Excellent written and verbal communication skills with the ability to influence cross-functional teams and effectively communicate complex scientific concepts.
- Ability to make sound medical decisions in ambiguous situations, reconcile differing scientific opinions, and communicate evidence-based recommendations to senior leadership and cross-functional stakeholders.
- Critical traits for success include strategic thinking, scientific curiosity, strong analytical skills, decisiveness, sound medical judgment, attention to detail, and the ability to influence without direct authority.
- Ability to work independently, prioritize effectively, and manage multiple complex initiatives simultaneously.
- Self-motivated, detail-oriented, and comfortable working in an entrepreneurial, fast-paced biotechnology environment where a hands-on approach is expected.
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