Septerna · 1 month ago
Vice President, Clinical Development
South San Francisco, California, United States
Full-time
Onsite
Director/Executive
$380K/yr - $420K/yr
10+ years expSepterna is a biotechnology company based in South San Francisco, CA focused on developing life-changing medicines through innovative drug discovery methods. The Vice President of Clinical Development will lead strategic clinical development initiatives and ensure the successful implementation of drug development programs while collaborating with various teams.
BiotechnologyInformation TechnologyMedicalSoftware
Responsibilities
Enterprise leader of program strategy, collaborating in a matrixed working environment with clinical operations, regulatory, clinical pharmacology, research, CMC, and other functions to ensure the success of drug development programs
Work with key internal and external stakeholders to lead the design and implementation of robust CDPs and integrated development plans to achieve the desired target product profile
Guide the development team(s) with aggressive, creative, but realistic approaches to drug development
Direct and design fit-for-purpose clinical trials across all phases in drug development; design and draft protocol synopses, clinical trial protocols, amendments, and supporting documents
Contribute to IBs, regulatory documents, CSRs, and publications associated with clinical trials
Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues
Be accountable via collaboration across functions and clinical operations for all relevant timelines and deliverables
Collaborate with regulatory affairs to develop high-quality strategic regulatory strategies and engagement
Communicate to management and relevant functions any potentially significant issues to the CDP or emerging safety risks in a timely manner
Provide strategic consultation and guidance to Research on decision that have significant clinical components and implications
Ensure compliance with SOPs, ICH, GCP, and other national and international regulatory requirements
In conjunction with the Chief Medical Officer, ensure organizational growth plans for clinical Development scales with Septerna’s current and future needs
Mentor and develop more junior physicians and other clinical development staff to successfully advance to higher levels of responsibility
Travel to clinical sites, conferences, and regulatory meetings as needed
Qualification
Required
MD or MD/PhD required and 10+ years of experience in Clinical Development or related pharmaceutical capacity
Proven track record of drug development in multiple therapeutic areas
Excellent communicator with team building and collaboration skills
In depth knowledge of drug development process and oversight of clinical trials; well versed in first-in-human trials as well as late phase development and product filing/ registration
Has seen and managed significant accelerations and challenges in clinical programs
Outstanding management skills a must, both with respect to managing the development team but also evidence of successful enterprise/matrix leadership
Demonstrated ability to lead cross-functional teams to make significant recommendations and persuasively present synthesis of team diligence to gain alignment with senior management
Expertise in innovative clinical trial design, scientific writing, and the successful implementation of clinical protocols and clinical study reports
Experience in all phases of regulatory submissions and interactions; international experience also required, along with negotiation experience with the FDA
Comprehensive knowledge of Good Clinical Practices (GCP), ICH, ICJME Guidelines, FDA and other international regulatory body requirements
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Superb presentation skills
Thrives in a highly entrepreneurial biotech environment
Preferred
Endocrinology/Board Certified Endocrinologist preferred
Rare disease experience is preferred
Benefits
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.
51-200 employees
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
Leadership Team
Jeffrey Finer
CEO and Co-Founder
A
Arthur Christopoulos
Co-Founder
Recent News
Company data provided by crunchbase