Director, Study Start-Up
Kymera Therapeutics
June 26, 2026
Remote friendly (Greater Boston)
United States
Clinical Research and Development
How you’ll contribute:
- Provide strategic and operational leadership for end-to-end study start-up activities across assigned clinical programs, ensuring timely, compliant, and high-quality site activation.
- Develop, execute, and optimize study-specific start-up strategies (country selection, regulatory/ethics submissions, site feasibility/selection, contract/budget execution, site activation readiness).
- Establish and maintain start-up timelines, metrics, and dashboards; identify risks and drive mitigation to achieve first-patient-in (FPI) and enrollment targets.
- Oversee country- and site-level regulatory/ethics submissions (e.g., IRB/EC/HA) aligned with global strategy and local requirements.
- Ensure quality, completeness, and inspection readiness of start-up documentation (including Trial Master File (TMF) content and country records) per GCP and internal SOPs.
- Partner with CRO(s) on site contract and budget negotiations to support activation timelines.
- Serve as primary escalation point for complex start-up challenges (site readiness/performance, regulatory delays, vendor issues); communicate status/resolutions to senior leadership.
- Provide start-up insights for portfolio planning (study design, country strategy, resourcing, feasibility).
- Develop/maintain start-up processes, systems, and tools to reduce cycle times and improve predictability.
- Ensure start-up activities comply with global regulations, internal policies, and quality standards; focus on patient safety and data integrity.
- Support audit/inspection readiness for start-up activities with Quality Assurance.
Skills and experience you’ll bring:
- 10+ years in biotech/pharmaceutical with direct Clinical Operations project management experience.
- Proven track record in process improvement, clinical trial execution, and operational strategy.
- Experience planning, managing, and overseeing Clinical Operations deliverables.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Proven ability to manage multiple concurrent projects/programs.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication/interpersonal skills; ability to influence cross-functional stakeholders.
- Ability to lead change and foster continuous improvement.
- Provide strategic and operational leadership for end-to-end study start-up activities across assigned clinical programs, ensuring timely, compliant, and high-quality site activation.
- Develop, execute, and optimize study-specific start-up strategies (country selection, regulatory/ethics submissions, site feasibility/selection, contract/budget execution, site activation readiness).
- Establish and maintain start-up timelines, metrics, and dashboards; identify risks and drive mitigation to achieve first-patient-in (FPI) and enrollment targets.
- Oversee country- and site-level regulatory/ethics submissions (e.g., IRB/EC/HA) aligned with global strategy and local requirements.
- Ensure quality, completeness, and inspection readiness of start-up documentation (including Trial Master File (TMF) content and country records) per GCP and internal SOPs.
- Partner with CRO(s) on site contract and budget negotiations to support activation timelines.
- Serve as primary escalation point for complex start-up challenges (site readiness/performance, regulatory delays, vendor issues); communicate status/resolutions to senior leadership.
- Provide start-up insights for portfolio planning (study design, country strategy, resourcing, feasibility).
- Develop/maintain start-up processes, systems, and tools to reduce cycle times and improve predictability.
- Ensure start-up activities comply with global regulations, internal policies, and quality standards; focus on patient safety and data integrity.
- Support audit/inspection readiness for start-up activities with Quality Assurance.
Skills and experience you’ll bring:
- 10+ years in biotech/pharmaceutical with direct Clinical Operations project management experience.
- Proven track record in process improvement, clinical trial execution, and operational strategy.
- Experience planning, managing, and overseeing Clinical Operations deliverables.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Proven ability to manage multiple concurrent projects/programs.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication/interpersonal skills; ability to influence cross-functional stakeholders.
- Ability to lead change and foster continuous improvement.