THE ROLEThe Director, Clinical Operations will lead the strategic planning, execution, and continuous improvement of Septerna's clinical programs across multiple therapeutic areas. This role is pivotal in a dynamic, fast-growing biotech environment and will ensure our clinical trials are delivered with excellence-on time, within budget, and in compliance with regulatory and quality standards.
This is an exciting opportunity with significant room for growth and visibility across the organization. The Director will work closely with senior leadership and cross-functional teams, gaining exposure to all levels of the company while helping to shape the future of Septerna's clinical operations. The ideal candidate combines deep operational expertise with a patient-first mindset, thrives in collaboration, and brings creativity and structure to a scaling organization.
Key Responsibilities- Lead operational planning and execution of clinical programs (Phase I-III, including patient-facing , global studies) in alignment with development goals.
- Oversee end-to-end delivery of clinical trials: define timelines, budgets, risk mitigation, resource allocation, and monitoring of results.
- Select, contract, and manage CROs and external vendors; build strong vendor relationships, ensure accountability to scope, budget, milestones, and quality.
- Collaborate across functions - Clinical Development, Regulatory, Biometrics/Data, QA, - to ensure aligned execution and streamlined decision-making.
- Build and mentor a growing clinical operations team; drive team development, foster a culture of learning, accountability, innovation, and high performance.
- Drive operational excellence by creating and implementing fit-for-purpose processes, systems and tools that support a scaling organization - standardizing templates, SOPs, dashboards, KPIs.
- Demonstrate ability to quickly adopt new therapeutic areas, adapt to evolving science and growing strategic demands.
- Bring creative, out-of-the-box thinking to optimize trial design, site operations, patient engagement, vendor strategies and operational efficiency.
- Ensure inspection readiness and adherence to ICH-GCP, SOPs and global regulatory standards; partner with QA to maintain operational integrity.
- Establish and track meaningful metrics (KPIs) to manage progress, proactively manage risks, and drive continuous improvement in trial efficiency and data quality.
Qualifications- Advanced degree (MS, PharmD, PhD) preferred; or bachelor's degree in life sciences/clinical research with equivalent robust experience.
- Minimum 10 years' experience in clinical operations in biotech or pharma, with leadership of multiple global clinical programs (including patient-facing studies).
- Demonstrated success in building and mentoring teams; experience in a growing/scaling environment is highly desirable.
- Proven track record managing CROs/external vendors, budgets/timelines, and operational delivery in a complex setting.
- Effective cross-functional collaborator; strong communicator able to navigate a matrixed, fast-moving organization.
- Experience in or ability to quickly learn new therapeutic areas (endorcrinology, immunology/inflammation, metabolic disease or similar) is strongly preferred.
- Demonstrated process-orientation: able to build, refine and standardize systems, tools, SOPs, dashboards and metrics.
- Strategic thinker with proactive, solution-driven mindset; able to bring innovative thinking to trial operations.
- Results-oriented, detail conscious, and adept at managing multiple priorities under deadlines.
The anticipated salary range for candidates who will work in South San Francisco, CA is $225,000 - $250,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
