Senior Medical Director, Clinical Development, Endocrinology/CAH
Job in
San Diego, San Diego County, California, 92189, USA
Listed on 2026-03-01
Listing for:
Neurocrine Biosciences
Full Time
position Listed on 2026-03-01
Job specializations:
-
IT/Tech
Job Description & How to Apply Below
Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.##
What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.
For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit , and follow the company on , and . (
* in collaboration with Abb Vie*)##
About the Role:
The Senior Medical Director, Clinical Development will serve as the medical and scientific leader for clinical development programs in congenital adrenal hyperplasia (CAH) and other new and emerging programs in endocrinology. This role provides end-to-end medical leadership across late-stage clinical development while also shaping early clinical strategies to support lifecycle expansion.
As the Program/Therapeutic Medical Lead, this individual will define and execute clinical development strategies across Phase 1–3 studies, partnering closely with cross-functional teams including Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety, Translational Medicine, Medical Affairs, and Research. The role requires deep endocrinology and rare disease expertise, strong regulatory acumen, and the ability to navigate complex scientific, clinical, and stakeholder landscapes to support global approvals and future growth opportunities.
## Your Contributions (include, but are not limited to):
** Clinical & Program Leadership
*** Serves as the Program/Therapeutic Medical Lead in endocrinology/CAH, providing medical leadership and accountability for clinical development strategy and execution
* Defines and drives integrated clinical development plans supporting late-stage development, regulatory filings, and post-approval commitments
* Leads clinical strategy for early-stage evaluation of new and emerging indications related to CAH and adrenal/endocrine disorders
* Provides medical leadership to cross-functional Program Teams, ensuring alignment of clinical strategy with scientific rationale, regulatory expectations, and business objectives
** Study Design, Execution & Oversight
*** Accountable for clinical trial design across Phase 1–3 studies, including development of study synopses, protocols, major amendments, and clinical study reports
* Oversees data collection strategies and leads interpretation of clinical efficacy, safety, and biomarker data
* Partners with Clinical Operations to oversee execution of clinical trials in accordance with NBI SOPs, Good Clinical Practice (GCP), and applicable global regulations
* Conducts medical review and disposition of adverse events in collaboration with Drug Safety, maintaining ongoing assessment of benefit–risk across the program
** Regulatory & Lifecycle Strategy
*** Provides clinical leadership for interactions with global regulatory authorities and supports preparation of INDs, NDAs, sNDAs, and other regulatory submissions
* Contributes to labeling strategy, pediatric development planning, and lifecycle management activities
* Anticipates regulatory and clinical risks and proactively develops mitigation strategies
** Scientific Communication & External Engagement
*** Leads analysis, interpretation, and…
Position Requirements
10+ Years
work experience
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