Director, Clinical Operational Excellence
Kymera Therapeutics
5 hours ago
Remote friendly (Greater Boston)
United States
Operations
How you’ll make an impact:
- Define and implement the long-term vision for Clinical Operations Excellence, ensuring alignment with corporate objectives and regulatory standards.
- Partner with senior leaders in Clinical Development, Quality, Regulatory, and other functions to harmonize processes and elevate trial execution.
- Lead the design and deployment of scalable, standardized processes, tools, and KPIs across clinical operations.
- Oversee operational performance dashboards, risk management frameworks, and trial health reporting to ensure proactive issue identification and resolution.
- Champion continuous improvement initiatives that enhance trial efficiency, cost-effectiveness, and speed-to-market.
- Partner with Quality Assurance to ensure inspection readiness and adherence to compliance frameworks.
- Develop and implement frameworks to ensure adherence to regulatory requirements and Good Clinical Practice (GCP) guidelines, including global regulatory requirements, ICH-GCP, and company SOPs.
- Develop training programs and support change management initiatives to embed best practices.
- Drive continuous process improvements to enhance operational efficiency, quality, and effectiveness in clinical oversight.
Skills and experience you’ll bring:
- 10+ years of experience in the biotech/pharmaceutical industry with direct experience in project management within Clinical Operations.
- Proven track record in process improvement, clinical trial execution, and operational strategy.
- Experience with planning, management, and oversight of activities and deliverables within Clinical Operations.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Proven track record of managing multiple projects and/or programs concurrently.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
- Demonstrated ability to lead change and foster a culture of continuous improvement.
Compensation:
- Anticipated base salary range: $195,000 – $275,000; eligible for annual bonus, equity participation, and comprehensive benefits.
- Define and implement the long-term vision for Clinical Operations Excellence, ensuring alignment with corporate objectives and regulatory standards.
- Partner with senior leaders in Clinical Development, Quality, Regulatory, and other functions to harmonize processes and elevate trial execution.
- Lead the design and deployment of scalable, standardized processes, tools, and KPIs across clinical operations.
- Oversee operational performance dashboards, risk management frameworks, and trial health reporting to ensure proactive issue identification and resolution.
- Champion continuous improvement initiatives that enhance trial efficiency, cost-effectiveness, and speed-to-market.
- Partner with Quality Assurance to ensure inspection readiness and adherence to compliance frameworks.
- Develop and implement frameworks to ensure adherence to regulatory requirements and Good Clinical Practice (GCP) guidelines, including global regulatory requirements, ICH-GCP, and company SOPs.
- Develop training programs and support change management initiatives to embed best practices.
- Drive continuous process improvements to enhance operational efficiency, quality, and effectiveness in clinical oversight.
Skills and experience you’ll bring:
- 10+ years of experience in the biotech/pharmaceutical industry with direct experience in project management within Clinical Operations.
- Proven track record in process improvement, clinical trial execution, and operational strategy.
- Experience with planning, management, and oversight of activities and deliverables within Clinical Operations.
- Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance.
- Proven track record of managing multiple projects and/or programs concurrently.
- Excellent analytical, problem-solving, and organizational skills.
- Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
- Demonstrated ability to lead change and foster a culture of continuous improvement.
Compensation:
- Anticipated base salary range: $195,000 – $275,000; eligible for annual bonus, equity participation, and comprehensive benefits.