Director, Clinical Sciences

Septerna•South San Francisco, CA

1d•$235,000 - $260,000

About The Position

Septerna is seeking an experienced and highly motivated Director of Clinical Sciences to provide scientific and operational leadership across our early clinical development programs. This individual will play a critical role in the design, execution, and interpretation of clinical studies, working cross-functionally to ensure high-quality, decision-ready data that advances our pipeline. The ideal candidate will bring deep expertise in clinical development, a strong scientific foundation, and the ability to operate effectively in a fast-paced biotech environment. This position will work closely with Clinical Development, Clinical Operations, Regulatory, Early Development, Biometrics, and Program Management functions and will report to the Senior Medical Director, Clinical Development.

Requirements

Bachelor’s degree in life sciences or related field; advanced degree (PhD, PharmD, or MD) strongly preferred.
10+ years of experience in Clinical Sciences, Clinical Development, or a related function within the biopharmaceutical industry.
Demonstrated experience supporting or leading early-phase clinical trials (Phase 1/2), including protocol development and data interpretation.
Strong understanding of clinical drug development, including study design, endpoints, and regulatory considerations.
Experience working in cross-functional teams, with the ability to influence without authority.
Excellent analytical, organizational, and communication skills, with the ability to translate complex data into clear insights.
High attention to detail and commitment to data quality and scientific rigor.
Ability to thrive in a dynamic, fast-paced environment and manage multiple priorities effectively.
Collaborative, hands-on, and solution-oriented mindset with a passion for advancing innovative therapies.

Responsibilities

Lead the design, planning, and execution of early-phase clinical trials (Phase 1 and Phase 2), including protocol development and study-related documents.
Drive development of key study documents including protocols, investigator brochures, clinical study reports (CSRs), and informed consent forms.
Collaborate with Clinical Operations to ensure effective study execution, including site selection, enrollment strategies, and timeline management.
Partner with multi-disciplinary team to define endpoints, biomarkers, and data analysis plans that enable clear interpretation of study results.
Contribute to clinical development plans, including indication strategy, study design, and dose selection.
Analyze and interpret clinical data; present findings to internal stakeholders and support decision-making at governance forums.
Support regulatory submissions (e.g., INDs/CTAs, briefing documents) and participate in health authority interactions as needed.
Identify clinical and operational risks and work proactively with cross-functional teams to develop mitigation strategies.
Ensure clinical studies are conducted in compliance with GCP and applicable regulatory requirements.
Contribute to building scalable Clinical Sciences processes and capabilities.