Sr. Director, Clinical Development

Who We Are

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 has FDA‑approved treatments for conditions such as tardive dyskinesia, chorea associated with Huntington’s disease, congenital adrenal hyperplasia, hyperphagia in Prader‑Willi syndrome, endometriosis and uterine fibroids, and a robust pipeline in mid‑ to late‑phase clinical development.

Responsible for leading development and execution on strategy and plans for Phase1–3 clinical studies while working with a multidisciplinary team (R&D project teams, clinical project managers, statisticians, data management, regulatory, drug safety). As needed, interfaces with Research, Translational and Experimental Medicine and Business Development to assess new product opportunities, develop clinical research strategy and product development plans.

• Directs and provides strategic guidance for Phase1–3 Clinical Trials in accordance with Neurocrine SOPs and GCP guidance.
• Leads the development and implementation of Clinical Development Plans and Study Protocols consistent with the Development Team direction.
• Leads the clinical team in the identification and selection of clinical investigators for clinical trials.
• Acts as point of contact for communication and professional relationship with NBI Clinical Investigators.
• Conducts assessment and disposition of adverse events (in conjunction with Medical Director if non‑physician) and evaluates safety of clinical compounds prior to and during ongoing clinical studies.
• Leads effort within clinical development program teams on selection of established and development of novel outcome measures in the context of clinical trials in early and late stages of clinical development.
• Oversees the clinical trials program in conjunction with the Clinical Operations.
• Analyzes, interprets, and presents results of clinical studies to internal and external audiences as directed by Senior Management.
• Leads and participates on multidisciplinary project teams.
• Identifies resource requirements, leads budget planning and personnel forecasting for clinical research programs.
• Leads recruitment, training and development of the clinical teams to ensure efficient operation of the function.
• Identifies and selects clinical consultants.
• Collaborates with external opinion leaders, internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
• Contributes in the scientific writing, including review and – as appropriate – approval of clinical study reports and related documents.
• Provides periodic status updates and effectively communicates with Senior Management Team.
• Responsible for developing the infrastructure and strategic planning to support advanced clinical trials.
• Together with cross‑functional team, establishes and implements strategy for regulatory processes with responsibility for all submissions and interactions with the FDA and other regulatory authorities.
• Remains up‑to‑date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
• Maintains knowledge of ICH‑GCP, external regulations and procedures – required for regulatory filing.
• Other duties as assigned.

• MS degree in Life Sciences or related field AND 15+ years of related experience in industry with expertise in the areas of drug development, operations and strategic planning.
• Specialty training appropriate to therapeutic area in addition to experience in clinical drug development (Phase1–4) in a pharmaceutical/biotechnology company. Prior experience working with CRO is a plus.
• Extensive previous managerial experience required.
• OR PharmD or PhD degree preferred AND 13+ years of similar experience.
• OR MD a plus AND 10+ years of similar experience.
• Recognized as an internal thought leader with…