Role Summary
Vice President or Senior Vice President, Clinical Development Operations. Provide visionary leadership across Clinical Development Operations, overseeing 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, collaborate cross-functionally to align program strategy with operational delivery, and lead vendor strategy and governance for external partners.
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
- Required: Bachelor's Degree and 15+ years of clinical operations leadership experience, with a strong track record managing global trials across phases (esp. Ph2βPh3), ideally in immunology/inflammation and/or large scale trials.
- Required: Demonstrated success building and leading large, multi-disciplinary teams in dynamic, matrixed environments.
- Required: Expertise in vendor oversight, budget and resource planning, and cross-functional team alignment.
- Required: Deep understanding of regulatory requirements and global GCP/ICH guidelines.
- Required: Inspirational people leader with excellent communication, decision-making, and change management skills.
- Preferred: Mission-driven, solutions-oriented, and thrives in a fast-paced biotech setting.
Skills
- Leadership of large, global clinical operations teams
- Vendor management and CRO oversight
- Strategic planning and program delivery
- Regulatory compliance and quality management
- Cross-functional collaboration and stakeholder alignment
Education
- Bachelor's Degree (field not specified in source)
Additional Requirements