Position Summary:
We are seeking a Senior Director, Clinical Operations, who acts as both a strategic leader and a tactical driver. This role is directly responsible for the clinical operations delivery of global clinical trials, requiring proven global clinical operations leadership. The successful candidate must be a leader who can pivot seamlessly from high-level strategic planning to the daily tactical details of operational execution.
The ideal candidate thrives in a fast-paced biotech environment, possessing a proven track record of building high-performing teams while remaining deeply involved in the clinical development lifecycle and vendor oversight.
This position follows a hybrid work model, requiring three days of onsite presence per week at our South San Francisco office.
Essential Duties and Responsibilities:
Strategic Leadership & Oversight
- Develop and drive clinical trial strategies aligned with corporate goals, while maintaining direct oversight of tactical delivery to ensure timelines and milestones are met.
- Drive late-stage clinical programs from planning through completion, providing the direct oversight necessary to ensure cost-effective, high-quality delivery
- Serve as the operational lead for clinical development programs, working closely with regulatory, medical, biostatistics, and other departments.
- Demonstrated success in managing global clinical trials across multiple therapeutic areas.
Team Leadership & Development
- Lead, mentor, and grow a team of clinical trial professionals including Clinical Project Managers, Clinical Research Associates, and other key stakeholders.
- Promote a culture of accountability, transparency, continuous improvement, and high performance.
Operational Excellence
- Oversee study start-up, site identification, patient recruitment, data collection, and monitoring processes.
- Ensure compliance with SOPs, ICH/GCP, and relevant regulatory requirements across all clinical activities.
- Develop, manage, and track clinical trial budgets, timelines, and resource allocation.
- Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials.
Vendor & CRO Management
- Select, contract, and manage CROs, central labs, and other third-party vendors.
- Establish and maintain productive relationships with key external partners to ensure deliverables are met.
Cross-Functional Collaboration
- Partner closely with Clinical Development, Regulatory Affairs, Quality Assurance, and Data Management teams.
- Represent clinical operations in leadership meetings and provide regular updates to executive stakeholders.
- Excellent communication and interpersonal skills with the ability to influence stakeholders at all levels.
Qualifications:
- BS or advanced degree in life sciences or related field.
- Prior Phase 3 global operational leadership is required, and cardio-metabolic experience is highly preferred.
- Minimum 12+ years of progressive experience in clinical research, with at least 5 years in senior leadership roles.
Travel Required:
Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $261,000 - $325,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.
At Structure, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.
