Vice President, Global Clinical Development, Oncology

Agenus; Lexington (MA); On-site; USD 250,000 - 350,000; Full time

Job summary

Agenus is seeking a Vice President, Global Clinical Development to lead worldwide oncology programs, with a focus on immunotherapy combinations such as botensilimab (BOT) plus balstilimab (BAL). This role requires strategic leadership across early phases through registrational trials and close collaboration with regulatory authorities to shape development plans.

You will oversee cross-functional teams in Clinical Operations, Translational Medicine, Biometrics, and Regulatory Affairs, drive trial

Qualifications

• MD or international equivalent with 12+ years in biotech/pharma.
• Extensive sponsor-led oncology drug development experience, especially immuno-oncology.
• Experience leading global programs from early to late-stage development; GI cancer experience desirable.

Responsibilities

• Define and execute global clinical strategies from early phases through registrational studies.
• Oversee trial design, indication and patient population selection, biomarker integration, and regulatory interactions.
• Regulatory authority discussions, especially with FDA and EMA, and external partnerships with investigators.
• Manage cross-functional teams in Clinical Operations, Translational Medicine, Biometrics, and Regulatory Affairs to meet milestones.
• Translate data interpretation, safety and efficacy into strategic, actionable decisions.

Education

MD or international equivalent

Job description

Role:

The Vice President, Global Clinical Development, leads Agenus’s worldwide oncology programs, focusing on immunotherapy combinations, notably botensilimab (BOT) plus balstilimab (BAL).

Responsibilities:

define and execute global clinical strategies from early phases through registrational studies, including trial design, indication and patient population selection, biomarker integration, and regulatory interactions. Oversees program development decisions, risk assessment, and ensures alignment with regulatory and scientific standards. Provides scientific and clinical leadership in external partnerships, investigator engagement, and regulatory authority discussions, especially with FDA and EMA. Manages cross-functional teams in Clinical Operations, Translational Medicine, Biometrics, and Regulatory Affairs to meet milestones and optimize study execution. Maintains oversight of data interpretation, safety, and efficacy, translating insights into strategic decisions.

Qualifications:

MD or international equivalent with 12+ years in biotech/pharma, extensive experience in sponsor-led oncology drug development, particularly immuno-oncology, with a solid track record of leading global programs from early to late-stage development. Prior experience in colorectal and gastrointestinal cancers is highly desirable. Demonstrates strong leadership, strategic thinking, regulatory expertise, and ability to influence senior stakeholders.

High-Value:

focus on immuno-oncology (checkpoint inhibitors), combination therapies, Phase 3 registrational trials, FDA/EMA regulatory interactions, and a preference for experience in colorectal and gastrointestinal oncology.

Work setup:

likely hybrid or flexible global environment, with significant external engagement.