Vice President, Global Clinical Development, Oncology

Agenus Inc.•Lexington, MA

102d

About The Position

The Vice President, 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 development leader with significant accountability for the global development strategy and registrational path for BOT+BAL, translating emerging clinical, translational, biomarker, regulatory, and competitive insights into clear development priorities and decisions. This is a hands-on leadership role requiring the ability to operate at both the strategic and executional level. The VP will be expected to set direction, challenge assumptions, make difficult development decisions, and personally drive critical scientific and clinical work within a lean, fast-moving organization.

Requirements

MD or international equivalent with 12+ 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.
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).
Demonstrated experience establishing and driving program-level clinical development strategy, beyond leadership of individual clinical studies.
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 experience making consequential development decisions involving indication strategy, patient selection, trial design, endpoints, regulatory strategy, and/or program prioritization.
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.
Significant experience interacting directly with FDA and/or other global health authorities, including responsibility for developing and defending clinical and scientific positions supporting development or registration strategy.
Broad and solid understanding of drug development, including preclinical research, clinical operations, regulatory affairs, pharmacovigilance, biometrics, translational medicine, 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 integrate clinical, translational, biomarker, regulatory, and competitive information into coherent program-level development strategy.
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.
Demonstrated ability to operate as a hands-on clinical development leader in a lean or resource-constrained environment, with willingness to personally develop critical work products rather than relying exclusively on large functional teams.
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.

Nice To Haves

Prior experience in immuno-oncology, immunotherapy, checkpoint inhibitors, or other immune-based therapies is strongly preferred.
Experience in colorectal cancer and/or gastrointestinal oncology is highly desirable.

Responsibilities

Lead global oncology development programs with accountability for clinical development strategy and execution from early development through registrational studies and regulatory submission, including study design, indication and patient population strategy, development priorities, and key program decisions.
Own and drive the global clinical development strategy for BOT+BAL, integrating clinical, translational, biomarker, regulatory, competitive, and other relevant considerations to establish development priorities and critical program decisions.
Shape the registrational strategy for BOT+BAL, including indication prioritization, patient selection, trial design, endpoints, sequencing, combination strategies, and the evidence required to support global registration.
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.
Continuously assess emerging clinical and external data to challenge existing development assumptions, identify program risks and opportunities, and recommend changes to development strategy when warranted.
Serve as a senior clinical development partner to executive leadership, providing clear recommendations regarding program strategy, development opportunities, scientific and regulatory risks, tradeoffs, and investment priorities.
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.
Provide clinical leadership for the execution of global oncology studies, partnering with Clinical Operations to drive enrollment, study timelines, data quality, and achievement of key development milestones.
Provide clinical development leadership and scientific oversight in support of early and expanded access programs, including authorized access programs in Europe, ensuring emerging clinical experience is appropriately integrated into broader development strategy.
Maintain senior medical and scientific oversight of clinical programs, ensuring patient safety, scientific integrity, and appropriate interpretation of emerging efficacy and safety findings.
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.
Provide senior clinical leadership in the resolution of complex medical, scientific, safety, and development issues that may affect program strategy or execution.
Lead the ongoing review, interpretation, and analysis of clinical trial data, ensuring scientific integrity while identifying emerging efficacy, safety, and biomarker trends that inform development and program decisions.
Ensure clinical, biomarker, translational, and external scientific data are integrated into a cohesive understanding of the program and translated into actionable development decisions.
Provide timely scientific interpretation of emerging data to executive leadership, governance committees, and cross-functional teams.
Partner closely with Biometrics, Translational Medicine, Clinical Operations, and other functions to ensure the data generated across the program are sufficient to answer critical development and registrational questions.
Provide senior clinical leadership for key technical and regulatory documents, including clinical study protocols, investigator brochures, clinical study reports, briefing documents, and clinical sections of global regulatory submissions, remaining sufficiently hands-on to personally author or shape critical content when needed.
Partner with Regulatory Affairs to define and drive global clinical regulatory strategy and represent the clinical development perspective in interactions with health authorities, including discussions supporting registrational development and BLA/MAA submissions.
Lead the clinical strategy and scientific rationale for significant interactions with FDA, EMA, and other global health authorities, including complex discussions that may affect study design, registrational strategy, development pathways, or potential marketing applications.
Anticipate potential regulatory challenges and develop evidence-based clinical strategies and arguments to address health authority questions or concerns.
Participate in and provide senior clinical leadership for DSMBs, Steering Committees, Scientific Advisory Boards, investigator meetings, and other internal and external scientific forums.
Provide strategic oversight of scientific communications, including publications, congress presentations, and external communication of clinical data.
Lead cross-functional clinical development teams and establish alignment across Regulatory Affairs, Translational Medicine, Clinical Operations, Pharmacovigilance, Biometrics, CMC, and other functions around development priorities, key decisions, timelines, and program risks.
Create clarity and accountability across functions, proactively identifying gaps or barriers to program progress and driving resolution in an environment where resources and infrastructure may be limited.
Partner with Clinical Operations on investigator, site, CRO, and vendor strategy and ensure clinical execution remains aligned with broader development objectives.
Influence decision making across the organization without relying solely on formal authority, bringing together differing scientific and functional perspectives to reach clear development decisions.
Build and maintain productive relationships with external scientific experts, investigators, and key opinion leaders.
Develop and leverage relationships with leading oncology investigators and KOLs to challenge and strengthen clinical development strategy, study design, patient selection, and interpretation of emerging data.
Establish credibility as a senior clinical and scientific leader and effectively communicate the scientific rationale, clinical data, and development strategy for BOT+BAL and other assigned programs.
Represent Agenus and its clinical development strategy externally with investigators, scientific advisors, partners, health authorities, and other key stakeholders.
Operate as a senior clinical development leader with the ability to set direction, influence decisions, challenge assumptions, and drive alignment across multidisciplinary teams.
Operate as a hands-on player-coach who can move seamlessly between high-level development strategy and personally driving critical scientific, clinical, and regulatory work when needed.
Demonstrate the ability to operate effectively without extensive functional infrastructure, independently identifying what needs to be done, resolving gaps, and moving programs forward with urgency.
Provide mentorship and clinical guidance to Clinical Development team members and contribute to building the capabilities of the broader organization.
Build accountability and strong decision-making practices across clinical development teams while developing and mentoring future clinical leaders.
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.