Director, Study Start-Up
Kymera Therapeutics
August 29, 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, and site activation readiness).
- Establish and maintain start-up timelines, metrics, and dashboards; identify risks and drive mitigations to achieve first-patient-in (FPI) and enrollment targets.
- Oversee country- and site-level regulatory and ethics submissions (IRB/EC/HA) consistent with global strategy and local requirements.
- Ensure quality/inspection readiness of start-up documentation (including TMF content and country-level records) per GCP and internal SOPs.
- Partner with CRO(s) to oversee site contract and budget negotiations aligned to approved study budgets and activation timelines.
- Serve as primary escalation point for complex start-up challenges; communicate status/resolution plans to senior leadership.
- Provide start-up insights for portfolio-level planning (study design, country strategy, resourcing, feasibility).
- Develop and maintain start-up processes/systems/tools to reduce cycle times and improve predictability.
- Ensure start-up activities comply with regulations, 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 biotech/pharma experience with project management in Clinical Operations.
- Proven process improvement, clinical trial execution, and operational strategy experience.
- Planning, management, and oversight of Clinical Operations activities/deliverables.
- Strong understanding of ICH-GCP and regulatory compliance.
- Track record managing multiple projects/programs concurrently.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication/interpersonal skills; ability to influence cross-functional stakeholders.
- Ability to lead change and drive continuous improvement.
Compensation:
- Anticipated base salary range: $195,000–$275,000; eligibility for annual bonus, equity participation, and comprehensive benefits.
- 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, and site activation readiness).
- Establish and maintain start-up timelines, metrics, and dashboards; identify risks and drive mitigations to achieve first-patient-in (FPI) and enrollment targets.
- Oversee country- and site-level regulatory and ethics submissions (IRB/EC/HA) consistent with global strategy and local requirements.
- Ensure quality/inspection readiness of start-up documentation (including TMF content and country-level records) per GCP and internal SOPs.
- Partner with CRO(s) to oversee site contract and budget negotiations aligned to approved study budgets and activation timelines.
- Serve as primary escalation point for complex start-up challenges; communicate status/resolution plans to senior leadership.
- Provide start-up insights for portfolio-level planning (study design, country strategy, resourcing, feasibility).
- Develop and maintain start-up processes/systems/tools to reduce cycle times and improve predictability.
- Ensure start-up activities comply with regulations, 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 biotech/pharma experience with project management in Clinical Operations.
- Proven process improvement, clinical trial execution, and operational strategy experience.
- Planning, management, and oversight of Clinical Operations activities/deliverables.
- Strong understanding of ICH-GCP and regulatory compliance.
- Track record managing multiple projects/programs concurrently.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication/interpersonal skills; ability to influence cross-functional stakeholders.
- Ability to lead change and drive continuous improvement.
Compensation:
- Anticipated base salary range: $195,000–$275,000; eligibility for annual bonus, equity participation, and comprehensive benefits.