Senior Medical Director, Clinical Development

Septerna•South San Francisco, CA

1d•$340,000 - $380,000•Onsite

About The Position

Septerna is a biotechnology company focused on developing life-changing medicines for patients with a vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company utilizes its Native Complex Platform™ to recapitulate GPCRs with their native structure, function, and dynamics outside of the cellular context, enabling novel access to modern structural and screening technologies for drug discovery. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth. The company is expanding its multidisciplinary team and seeks individuals focused on creating revolutionary medicines to address unmet patient needs. Septerna values diversity of thought, expertise, and background through collaboration, and fosters an environment where employees can bring their authentic selves to work, grow and learn from a talented team, and contribute their passion, creativity, and energy to the company's mission. The company is committed to developing meaningful therapeutics for patients with indications of high unmet need and offers an opportunity to work on the frontlines of therapeutic discovery and development, directly contributing to moving therapies through preclinical research and positioning them for clinical success. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.

Requirements

MD or MD/PhD required
5+ years of experience in Clinical Development or related pharmaceutical capacity
Endocrinology/Board Certified Endocrinologist or extensive experience in endocrinology-related drug-development required
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

Nice To Haves

Rare disease experience is preferred

Responsibilities

Provide strategic leadership in clinical development strategy, planning, and tactical implementation for all clinical development functions.
Serve as the Clinical Development leader for one of Septerna’s clinical stage programs.
Be responsible for the design and successful cross-functional implementation of the clinical development plan (CDP).
Participate in regulatory interactions and contribute to building relationships with KOLs.
Bridge clinical, scientific, and business needs with the aptitude to translate and align business and scientific goals and objectives.
Act as an 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 decisions 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.