Director, Clinical Development

About the role

Responsible for developing strategy and plans for Phase 1‑3 clinical studies while collaborating with multidisciplinary teams including R&D, project management, statistics, data management, regulatory, and drug safety. The role also interfaces with Research and Business Development to assess new product opportunities.

Key responsibilities

• Direct Phase 1‑3 clinical trials in accordance with Neurocrine SOPs and GCP guidance.
• Develop and implement study protocols aligned with development team direction.
• Select and manage clinical investigators and maintain professional relationships.
• Assess adverse events, evaluate safety, and lead outcome‑measure selection.
• Oversee clinical trial programs with Clinical Operations and present study results to internal and external audiences.
• Identify resource needs, assist in budget planning, and support recruitment and training of clinical teams.
• Lead regulatory strategy, manage submissions and interactions with FDA and other authorities.

Required profile

• MS degree in Life Sciences (or PharmD/PhD) with 10+ years of industry experience in drug development, operations, and strategic planning.
• Extensive managerial experience and recognized as an internal thought leader.
• Strong interpersonal, communication, and leadership skills with ability to influence across matrix organizations.
• Proactive, innovative problem‑solver with ability to work cross‑functionally.

Required skills

• Phase 1‑3 clinical trial design and execution.
• ICH‑GCP compliance.
• Regulatory submissions (IND, NDA) and interactions with health authorities.
• Biostatistics and data analysis.
• Clinical operations and CRO management.