Septerna · 12 hours ago
Director/Senior Director, Clinical Operations
Septerna is a biotechnology company based in South San Francisco, CA focused on developing life-changing medicines. The Director/Senior Director, Clinical Operations will lead the strategic planning and execution of clinical programs, ensuring clinical trials are delivered with excellence and compliance.
BiotechnologyInformation TechnologyMedicalSoftware
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
Qualification
Required
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
Benefits
Stock options
Annual target bonus for full-time positions
Company
Septerna
Septerna is a biotech firm unlocking diverse drug discovery potential in G protein-coupled receptors across various diseases.
H1B Sponsorship
Septerna has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
RA Capital ManagementThird Rock Ventures
2024-10-25IPO
2023-09-12Acquired
2023-07-11Series B· $150M
Recent News
Company data provided by crunchbase