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Role Summary
Vice President or Senior Vice President, Clinical Development Operations, responsible for visionary leadership of Clinical Development Operations, overseeing end-to-end global trial execution across multiple programs and phases, building scalable operational capabilities, and ensuring GCP compliance, patient safety, and data integrity.
Responsibilities
- Provide visionary leadership across Clinical Development Operations, cultivating a high-performing, collaborative culture.
- Oversee end-to-end global trial execution across multiple programs and phases, with a focus on quality, timeliness, and budget adherence.
- Build and scale operational capabilities, including process optimization, systems implementation, and inspection readiness.
- Collaborate cross-functionally with Clinical Development, PM and Program Leader, Regulatory, Data Sciences, Safety, and CMC to align program strategy with operational delivery.
- Lead vendor strategy and governance for CROs, central labs, and other external partners, ensuring accountability and performance.
- Actively contribute to strategic planning, scenario modeling, and regulatory submissions for global programs.
- Ensure trials meet the highest standards of GCP compliance, patient safety, and data integrity.
- Serve as a key member of Kymeraβs development leadership team, and on R&D program review meetings, helping shape the broader clinical strategy and culture.
Qualifications
- Bachelor's Degree and 15+ years of clinical operations leadership experience, with a strong track record managing global trials across phases (especially Ph2βPh3), ideally in immunology/inflammation and/or large-scale trials.
- Demonstrated success building and leading large, multi-disciplinary teams in dynamic, matrixed environments.
- Expertise in vendor oversight, budget and resource planning, and cross-functional team alignment.
- Deep understanding of regulatory requirements and global GCP/ICH guidelines.
- Inspirational people leader with excellent communication, decision-making, and change management skills.
- Mission-driven, solutions-oriented, and thrives in a fast-paced biotech setting.
Education
- Bachelor's Degree required (in a relevant field).