Overview As a key clinical operations leader, you will drive cross-functional delivery of Immunome's clinical trials, ensuring studies are planned, launched, executed, and closed on time and within budget. You will own study timelines, enrollment forecasting, budgets, and vendor performance, serving as a subject-matter expert for trial delivery. You will mentor junior team members, oversee CROs and central labs, and help maintain regulatory readiness across programs. This role offers impact across a rapidly expanding oncology portfolio and opportunities to shape trial delivery and program-level decisions.
Responsibilities- Own cross-functional facilitation of study teams through the trial lifecycle
- Develop and maintain study-level timelines and reporting
- Create enrollment dashboards and ensure data accuracy for decision-making
- Monitor delivery metrics and drive corrective actions when at risk
- Lead delivery of trials on time, within budget, and to quality standards
- Identify operational risks and implement mitigations
- Support resource planning and capability building
- Mentor and coach Clinical Operations staff
- Manage CROs and central labs, including vendor onboarding and performance oversight
- Lead governance meetings and drive issue escalation and resolution
- Ensure compliance with ICH-GCP, FDA, EMA and global regulations
- Collaborate with Clinical Site Operations and Development Systems to align strategy
- Provide study-level input into program decisions and regulatory submissions
- Track budget adherence and Change Orders with Finance
Key requirements- 8+ years of clinical project management experience (AD) or 10+ years (Director) in biotech/pharma
- Experience directly managing clinical trial vendors including CROs and central labs
- Proven ability to develop study timelines, enrollment forecasting, and risk management
- Track record of managing complex clinical trials in biotech/pharma environment
- Deep understanding of clinical development and global regulatory frameworks (ICH-GCP, FDA, EMA)
- Strong project management skills; PMP certification preferred
- Ability to influence stakeholders cross-functionally without direct authority
- Excellent communication, negotiation, and interpersonal skills
- Analytical mindset with strategic problem-solving and decision-making
- Ability to manage multiple complex projects and vendors in a fast-paced setting
- Professional, adaptable, and accountable
- cross-functional collaboration
- stakeholder influence
- analytical mindset
- project management
- vendor management (CROs, central labs)
- timeline development and tracking
