Medical Director, Clinical Development, Psychiatry

Neurocrine Biosciences • San Diego, CA

1d • Onsite

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company 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 and a robust pipeline. This role is responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies, working with cross-functional project teams. The position may also involve developing biomarkers, providing medical oversight of Drug Safety activities, and partnering with Business Development in assessing external innovation. Strong leadership is valued, focusing on strategic thinking, clear direction, and building high-performing teams.

Requirements

• MD or DO degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required.
• 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 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.

Responsibilities

• Develops and implements study protocols 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.
• 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.

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree