Director/Senior Director, Clinical Operations jobs in United States
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Septerna · 9 hours ago

Director/Senior Director, Clinical Operations

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients. The Director/Senior Director, Clinical Operations will lead the strategic planning, execution, and continuous improvement of Septerna’s clinical programs across multiple therapeutic areas, ensuring clinical trials are delivered with excellence.

BiotechnologyInformation TechnologyMedicalSoftware
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H1B Sponsor Likelynote

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

Clinical operations leadershipCRO managementBudget managementRegulatory complianceTeam buildingProcess standardizationCross-functional collaborationEffective communicationStrategic thinkingDetail-oriented

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
Demonstrated process-orientation: able to build, refine and standardize systems, tools, SOPs, dashboards and metrics
Results-oriented, detail conscious, and adept at managing multiple priorities under deadlines

Preferred

Experience in or ability to quickly learn new therapeutic areas (endorcrinology, immunology/inflammation, metabolic disease or similar) is strongly preferred
Strategic thinker with proactive, solution-driven mindset; able to bring innovative thinking to trial operations

Benefits

Benefits
Stock options
Annual target bonus for full-time positions

Company

Septerna

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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 Company
Total Funding
$250M
Key Investors
RA Capital ManagementThird Rock Ventures
2024-10-25IPO
2023-09-12Acquired
2023-07-11Series B· $150M

Leadership Team

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Jeffrey Finer
CEO and Co-Founder
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A
Arthur Christopoulos
Co-Founder
Company data provided by crunchbase