Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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 neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)
At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.
Responsible for providing medical and scientific support across clinical development activities, with emphasis on protocol development and study design review, clinical data interpretation, site and PI interaction, regulatory response documents, ongoing safety review, and medically relevant vendor and operational deliverables.
Works cross-functionally with Clinical Operations, Regulatory, Biostatistics, Data Management, Drug Safety, Clinical Pharmacology, Translational Medicine, Medical Writing, vendors, and investigators to ensure clinical accuracy, participant safety, protocol alignment, and timely execution of study deliverables across Phase 1-4 programs.
_
Provide medical and scientific input into clinical study designs, synopses, protocols, amendments, informed consent forms, and related study documents across early- and late-stage development
Review study objectives, endpoints, eligibility criteria, safety monitoring, visit schedules, biomarker strategies, and operational feasibility to ensure studies are clinically meaningful, patient-appropriate, executable, and aligned with regulatory objectives
Review draft tables, figures, listings, data summaries, and clinical narratives for accurate presentation and appropriate interpretation of safety, efficacy, pharmacodynamic, laboratory, and subject-level data
Support the drafting, medical review, and finalization of health authority, ethics committee, IRB, EU CTR, CTA/RFI, and related response documents, ensuring scientific accuracy, clinical relevance, and alignment with the protocol, development strategy, benefit-risk position, and cross-functional input. Identify medical or scientific inconsistencies, missing analyses, data-quality issues, and presentation or interpretation concerns; partner with Biostatistics, Data Management, Clinical Operations, Drug Safety, and Medical Writing to resolve issues before internal or external use
Perform ongoing medical review of study outputs, safety listings, laboratory data, protocol deviations, concomitant medications, data review meeting materials, and other emerging clinical data to identify potential safety signals, data-quality issues, or clinically relevant trends
Provide medical interpretation of adverse events, laboratory abnormalities, safety trends, and clinically relevant subject-level data; escalate participant-safety, study-integrity, or decision-critical issues when appropriate
Review study-related vendor manuals, process documents, data-transfer specifications, assessment plans, imaging or device instructions, patient-facing materials, and site guidance for medical appropriateness, protocol alignment, feasibility, and participant focus
Collaborate with internal functions, vendors, and external investigators to synthesize input, resolve inconsistencies, present data, and drive documents and decisions to completion under time-sensitive conditions
Other duties as assigned
MD or DO degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required AND 2+ years of experience in clinical research and development (Phase 1-4) in either a pharmaceutical/biotechnology company or a clinical research/academic environment or related experience required
Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
Applies strong medical judgment, clinical development experience, and scientific rigor to complex development questions and cross-functional deliverables
Communicates clearly in writing and verbally, with the ability to summarize medical issues, identify decision points, and provide pragmatic recommendations
Works independently, manages multiple priorities, and delivers high-quality document review and data interpretation under compressed timelines
Operates effectively in a matrix environment and builds productive relationships with internal teams, vendors, investigators, and other external partners
MD with accredited residency training in a relevant clinical specialty required; board certification or eligibility preferred. Experience in endocrinology, pediatric endocrinology, rare diseases, metabolic disease, or a related translational/safety-relevant specialty is preferred
Hands-on experience in clinical research and drug development, including early clinical development, protocol design, endpoint selection, benefit-risk assessment, safety monitoring, and interpretation of emerging efficacy and safety data across Phase 1-4 studies
Knowledge of Good Clinical Practice, global clinical trial regulations, EU CTR/CTA processes, health authority questions, RFI responses, protocol amendments, and ethics committee or IRB interactions
Ability to review subject-level data, adverse events, laboratory trends, protocol deviations, concomitant medications, safety listings, and draft TFLs, and to distinguish data-quality issues from true medical signals
Working understanding of how protocols, SAPs, estimands/endpoints, analysis sets, visit windows, and TFL shells connect to final clinical interpretation and regulatory communication
Demonstrated ability to collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, Drug Safety, Clinical Pharmacology, Translational Medicine, Medical Writing, vendors, and external investigators to resolve issues and complete deliverables
#LI-OS1
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
