Medical Director, Clinical Development, Psychiatry

Neurocrine Biosciences; San Diego (CA); On-site; USD 254,600 - 347,000; Full time

Benefits offered by this job

Retirement plan

Paid time off

Health benefits

Job summary

Neurocrine Biosciences is a leading biopharmaceutical company focused on developing treatments for neurological, psychiatric and endocrine disorders. The role leads clinical program strategy and independent direction of Phase1-3 studies with cross-functional teams including project managers, pharmacology, biometrics, regulatory and drug safety.

Responsibilities include medical oversight of safety activities, biomarker development for early molecules, and collaboration with Medical Affairs to

Qualifications

• MD or DO with residency and board certification in a relevant clinical specialty; 2+ years in clinical R&D
• Internal thought leader with extensive technical and business expertise within a strategic organization
• Strong interpersonal and communication skills; ability to lead cross-functional teams
• Knowledge of Good Clinical Practice (GCP) and regulatory procedures relevant to investigational drug development
• Experience in translational medicine and biomarker evaluation, clinical study execution and data interpretation

Responsibilities

• Develops and implements study protocols with a multidisciplinary Development Team
• Identify clinical investigators and maintain sponsor relationships as the medical monitor/representative
• Conduct medical assessment and disposition of adverse events and evaluate safety of clinical compounds
• Oversee the clinical trials program in accordance with SOPs, GCP, and regulations
• Lead biomarker strategy development for early clinical development
• Collaborate with Medical Affairs and external leaders to secure collaborators and present trial results
• Interface with Research, Product Development and Business Development to plan new opportunities

Skills

Clinical leadership

Biomarker strategy

Regulatory knowledge

Cross-functional collaboration

Biostatistics

Education

MD or DO degree

Job description

Who We Are:

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)

About the Role:

Responsible for the development of clinical research strategies and independent direction of Phase1-3 clinical studies while working with a cross‑functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety). May work closely with Research and Preclinical Development to develop biomarkers necessary for the most effective evaluation of novel molecules in early clinical development. Responsible for medical oversight of Drug Safety activities in conjunction with operational activities of the Drug Safety Director. Partners with Business Development in the assessment of external innovation.

Your Contributions:

• Develops and implements study protocols as in conjunction with a multidisciplinary Development Team
• Assist in the identification and selection of clinical investigators for clinical trials and maintain appropriate communication and professional relationships as Sponsor medical monitor/representative
• Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies
• Oversee the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations
• Analyze, interpret, and present results of clinical studies to internal and external audiences as directed by Sr. Management
• Identify resource requirements, assist in budget planning and personnel forecasting for clinical research programs
• Assists in the recruitment, training and development of the clinical teams
• Identify and select clinical consultants
• Provide or assist in the scientific writing and review of clinical study reports and related regulatory documents
• Provides periodic status updates and effectively communicates with Senior Management Team
• Leads the development of clinical biomarker strategies for early clinical development
• Assist in the recruitment, training and development of the clinical teams
• Work with Medical Affairs and external opinion leaders to secure new collaborators and present trial results
• Interface with Research, Product Development and Business Development to assess new product opportunities, develop clinical research strategy and product development plans
• Other duties as assigned

Requirements:

• 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 (Phase1-4) 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 in‑depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross‑functional impact
• Strong interpersonal and communication skills as well as strong organizational and team leadership skills are required
• Able to work independently and prioritize multiple tasks and goals to ensure the timely, on‑target and within‑budget accomplishment
• Knowledgeable in Good Clinical Practice, regulatory procedures relevant to investigational drug development
• Strong knowledge in translational medicine and biomarker evaluation, clinical study execution, regulatory requirements and documents, study design, biostatistics, data analysis, report writing, and scientific presentation of data
• Able to effectively operate in a multi‑level matrix corporate environment, requiring interaction with, and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel
• Demonstrated success managing interactions with external CROs, consultants and other contract organizations, especially from the context of a small group
• Proven track record of success across all phases of drug development, proven success record in clinical trial design
• #LI‑KM1

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.

The annual base salary we reasonably expect to pay is $254,600.00-$347,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2025. We were also named a Great Place to Work Certified company.

OUR VALUES:

• PASSION: We are driven and love what we do.
• INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.
• COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.
• INNOVATION: We seek and create optimal solutions.
• TENACITY: We do not quit. We adapt. We accomplish what others cannot.

Come join our team during this exciting time of growth and opportunities!

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