About The RoleSepterna has an exciting new opportunity to join the team as a Medical Director/ Senior Medical Director, who will provide strategic leadership clinical development strategy, planning, and tactical implementation for all clinical development functions. This position will also serve as the Clinical Development leader for one of Septerna's clinical stage programs. This person is responsible for the design and successful cross-functional implementation of the clinical development plan (CDP). S/he will also participate in regulatory interactions and contribute to building relationships with KOLs. Ability to bridge clinical, scientific, and business needs with the aptitude to translate and align business and scientific goals and objectives. Must be a dynamic leader with outstanding strategic, communication, and collaboration skills.
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 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 VP of Clinical Development, 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.
Qualifications- MD or MD/PhD required and 5+ years of experience in Clinical Development or related pharmaceutical capacity.
- Endocrinology/Board Certified Endocrinologist or extensive experience in endocrinology-related drug-development required.
- Rare disease experience is preferred.
- 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.
The anticipated salary range for candidates who will work in South San Francisco, CA is $340,000 - $380,000. 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.
