Position Summary:
- Vice President, Clinical Development (Nephrology) β project co-lead providing overall clinical, scientific, and strategic oversight for rare kidney disease programs across Phases 1β4.
Responsibilities:
- Serve as Global Development Physician Lead for assigned programs (Program Strategy Team) and represent programs to executive leadership and study teams.
- Communicate program goals, strategies, plans, issues, and risks to stakeholders and executives.
- Lead development of protocols and clinical/scientific strategy for Phase 1β4.
- Provide expertise across development/regulatory strategy (pre-IND to NDA/BLA) and devices (Human Factor studies).
- Contribute strategic input for rare metabolic/genetic disease landscape, biometrics analyses, publications, and presentations.
- Partner with Biometrics and Medical Affairs on data planning, analysis, interpretation, and scientific communications.
- Ensure clinical accountabilities for protocols, investigator brochures, medical reports, efficacy/safety summaries, rationales, and benefit/risk.
- Lead/mentor Clinical Development staff and consultants; foster a high-performance culture.
- Establish relationships with stakeholders (alliance partners, external companies, investigators, KOLs); attend investigator and site initiation meetings.
- Support governance presentations and represent key decisions cross-functionally.
Education/Experience Requirements:
- M.D. or M.D./Ph.D.; nephrology training and rare kidney disease drug development strongly preferred.
- 12+ years clinical research (design/execution of clinical trials in pharma/biotech); 8+ years leadership experience.
- Demonstrated ability to lead cross-functional teams in a matrix environment.
- NDA/BLA submissions experience preferred.
Additional Skills/Requirements:
- Courage, Community Spirit, Patient Focus, Teamwork.
- Strong communication, organizational, and interpersonal skills; ability to present complex data.
- Experience with devices/human factors preferred.
- Ability to work inclusively in multidisciplinary teams; manage complexity and shifting priorities.
- Ability to travel domestically/internationally (up to 25β30%); onsite presence in San Diego required (not 100% remote).
Application Instructions:
- Applications accepted on an ongoing basis until a candidate is selected.