Clinical Project Manager

The role:

At Agenus, we’re on a mission to bring breakthrough immuno-oncology treatments to patients who need them most and as a Clinical Project Manager, you’ll be at the heart of that mission. In this role, you will apply your project management expertise to lead the planning and execution of late-stage clinical programs, with a focus on Phase II and III studies. You’ll be responsible for driving timelines, budgets, and cross-functional deliverables that advance programs toward critical regulatory milestones, including BLA submission. Acting as the central coordinator, you will align internal teams and external partners, mitigate risks, and ensure seamless progress across complex workstreams. If you thrive on bringing structure and accountability to high-impact projects and want to see your leadership directly contribute to therapies reaching patients, Agenus offers the opportunity to make that vision a reality.

In the role you will:

Strategic and operational planning

• Develop comprehensive project plans, including scope, budget, and timeline management for clinical studies.
• Formulate study-level operational strategies and risk mitigation plans.
• Contribute to the design and refinement of study protocols.
• Provide expertise and support for study concepts during early development.

Team leadership and communication

• Lead and manage cross-functional clinical study teams, clinical research associates, and biostatisticians.
• Serve as a point of contact for external partners like vendors, Clinical Research Organizations (CROs), and investigator sites.
• Act as the liaison between internal stakeholders, external vendors, and clinical investigators.
• Assist in the conduct regular team meetings and present project updates and progress reports to senior management.

Vendor and budget management

• Monitor CROs and other third-party vendors.
• Contribute to vendor contract and budget negotiations.
• Assist in tracking overall trial budget, financials, and invoice approvals.

Trial execution and regulatory compliance

• Work closely with other PMs with respect to clinical trial activities from initiation through closeout, overseeing site identification, feasibility, and activation.
• Ensure the Trial Master File (TMF) is audit-ready and all study documentation is accurate and compliant.
• Ensure strict adherence to Good Clinical Practice (GCP), ICH guidelines, and all other relevant regulatory standards.
• Support the preparation and review of regulatory documentation for submissions to health authorities and ethics committees.

Data quality and risk management

• Assist in the assurance of the accuracy and integrity of clinical trial data, working with data management teams.
• Identify and manage potential risks and issues that arise during a trial, developing and implementing mitigation strategies.
• Review study metrics and implement corrective actions to address issues with quality or recruitment.

Qualifications: About You

• Bachelor's degree (required) or Master's degree in a scientific discipline, clinical trials management, or a related field. Extensive clinical research experience (7–10+ years)
• Direct project management experience: At least 3–5 years in a clinical project management role, managing full-scale clinical trials.
• Phase II/III trial experience (4+ years): Preferred for pharmaceutical or biotech roles.
• Global study experience (beneficial): Experience managing global clinical trials.
• CRO/vendor management experience (required): Direct experience overseeing contract research organizations and vendors.
• Leadership and team management: Proven ability to lead, mentor, and motivate cross-functional teams.
• Project management: Strong skills in planning, budgeting, risk management, and tracking complex projects.
• Communication: Excellent written and oral communication skills for effective stakeholder engagement.
• Regulatory knowledge: Thorough understanding of ICH-GCP guidelines, FDA, and other regulatory requirements.
• Technical skills: Proficiency with clinical trial management software (CTMS), electronic data capture (EDC), and standard project management tools.
• Adaptability and problem-solving: Ability to respond to challenges and adapt to changing priorities in a fast-paced environment.

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