Responsibilities (Goals/Accountabilities)
- Lead and direct execution of multiple clinical program(s) within a TAU.
- Provide clinical operations leadership and line management; counsel on issue resolution.
- Ensure overall program execution with focus on quality, budget, and timelines.
- Oversee Strategic Partners and vendors to meet ICH-GCP and business objectives.
- Oversee COPLs as members of the Global Program Team (GPT) and/or CST.
- Escalate/communicate program issues and represent Clinical Operations to senior management and governance committees.
- Contribute to Clinical Development Plan(s) and operational strategy supporting Asset Strategy.
- Own program budget planning and external spend accuracy (with Global Program Management and Finance).
- Support inspection readiness; guide COPLs/COMs for inspection activities.
- Ensure adequate clinical operations resources are assigned to programs.
- Act as a role model for leadership behaviors and values; lead cross-functional initiatives.
- May provide operational due diligence for business development/in-licensing/alliances.
Qualifications / Required Experience & Skills
- Bachelorβs degree or international equivalent (Life Sciences preferred); advanced degree highly desirable.
- 12+ years pharmaceutical experience, including 9+ years clinical study management.
- Early phase and/or Phase 2/3 experience; global/international programs.
- Oncology experience required.
- Global regulatory/compliance expertise (US CFR, EU CTD, ICH-GCP) and local requirements awareness.
- Supervisory experience; strong project/program management and matrix leadership.
- Fluent business English; able to influence without authority.
Preferred/Advantageous
- Experience in multiple therapeutic areas; line management advantageous.
Benefits
- US employees may be eligible for medical/dental/vision, 401(k) w/ company match, disability and life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, and up to 80 hours sick time; up to 120 hours paid vacation for new hires.
Application Instructions
- Apply via the βApplyβ button (submission begins the employment application process).