Sr. Director, Clinical Operations
Structure Therapeutics
12 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary:
- Senior Director, Clinical Operations; strategic leader and tactical driver responsible for clinical operations delivery of global clinical trials. Must pivot from high-level planning to daily execution in a fast-paced biotech environment.
- Hybrid role: 3 days onsite per week at the South San Francisco office.
Essential Duties and Responsibilities:
Strategic Leadership & Oversight
- Develop and drive clinical trial strategies aligned with corporate goals; ensure timelines and milestones are met.
- Drive late-stage clinical programs from planning through completion; ensure cost-effective, high-quality delivery.
- Serve as operational lead for clinical development programs with Regulatory, Medical, Biostatistics, and other departments.
- Demonstrated success managing global clinical trials across multiple therapeutic areas.
Team Leadership & Development
- Lead, mentor, and grow clinical trial teams (e.g., Clinical Project Managers, Clinical Research Associates, and other stakeholders).
- Promote accountability, transparency, continuous improvement, and high performance.
Operational Excellence
- Oversee study start-up, site identification, patient recruitment, data collection, and monitoring.
- Ensure compliance with SOPs, ICH/GCP, and relevant regulatory requirements.
- Develop/manage/track clinical trial budgets, timelines, and resource allocation.
Vendor & CRO Management
- Select, contract, and manage CROs, central labs, and other third-party vendors.
- Maintain partner relationships to ensure deliverables are met.
Cross-Functional Collaboration
- Partner with Clinical Development, Regulatory Affairs, Quality Assurance, and Data Management.
- Represent clinical operations in leadership meetings; provide updates to executive stakeholders.
- Excellent communication/interpersonal skills to influence stakeholders.
Qualifications
- BS or advanced degree in life sciences or related field.
- Prior late-stage global operational leadership (cardio-metabolic experience highly preferred).
- 12+ years progressive clinical research experience; at least 5 years in senior leadership roles.
Travel Required:
- Up to 20%.
Benefits (as stated):
- Annual performance incentive bonus, new hire equity, ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, and paid holidays (including winter shutdown).
- Senior Director, Clinical Operations; strategic leader and tactical driver responsible for clinical operations delivery of global clinical trials. Must pivot from high-level planning to daily execution in a fast-paced biotech environment.
- Hybrid role: 3 days onsite per week at the South San Francisco office.
Essential Duties and Responsibilities:
Strategic Leadership & Oversight
- Develop and drive clinical trial strategies aligned with corporate goals; ensure timelines and milestones are met.
- Drive late-stage clinical programs from planning through completion; ensure cost-effective, high-quality delivery.
- Serve as operational lead for clinical development programs with Regulatory, Medical, Biostatistics, and other departments.
- Demonstrated success managing global clinical trials across multiple therapeutic areas.
Team Leadership & Development
- Lead, mentor, and grow clinical trial teams (e.g., Clinical Project Managers, Clinical Research Associates, and other stakeholders).
- Promote accountability, transparency, continuous improvement, and high performance.
Operational Excellence
- Oversee study start-up, site identification, patient recruitment, data collection, and monitoring.
- Ensure compliance with SOPs, ICH/GCP, and relevant regulatory requirements.
- Develop/manage/track clinical trial budgets, timelines, and resource allocation.
Vendor & CRO Management
- Select, contract, and manage CROs, central labs, and other third-party vendors.
- Maintain partner relationships to ensure deliverables are met.
Cross-Functional Collaboration
- Partner with Clinical Development, Regulatory Affairs, Quality Assurance, and Data Management.
- Represent clinical operations in leadership meetings; provide updates to executive stakeholders.
- Excellent communication/interpersonal skills to influence stakeholders.
Qualifications
- BS or advanced degree in life sciences or related field.
- Prior late-stage global operational leadership (cardio-metabolic experience highly preferred).
- 12+ years progressive clinical research experience; at least 5 years in senior leadership roles.
Travel Required:
- Up to 20%.
Benefits (as stated):
- Annual performance incentive bonus, new hire equity, ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, and paid holidays (including winter shutdown).