Sr. Director, Clinical Development
Neurocrine Biosciences
9 days ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Responsible for leading development and execution on strategy and plans for Phase 1-3 clinical studies with a multidisciplinary team (R&D project teams, clinical project managers, statisticians, data management, regulatory, drug safety). Interfaces with Research, Translational and Experimental Medicine and Business Development to assess new product opportunities and develop clinical research strategy and product development plans.
Your Contributions (include, but are not limited to)
- Directs and provides strategic guidance for Phase 1-3 Clinical Trials in accordance with Neurocrine SOPs and GCP.
- Leads Clinical Development Plans and Study Protocols.
- Leads identification and selection of clinical investigators.
- Serves as point of contact and maintains professional relationship with Clinical Investigators.
- Assesses and disposes of adverse events and evaluates safety of clinical compounds.
- Leads selection of established and novel outcome measures.
- Oversees clinical trials program with Clinical Operations.
- Analyzes, interprets, and presents clinical study results.
- Leads and participates on multidisciplinary project teams.
- Identifies resources, leads budget planning and personnel forecasting.
- Recruits, trains, and develops clinical teams.
- Identifies/selects clinical consultants; collaborates with opinion leaders to ensure study design and data analysis success.
- Contributes to scientific writing, including review/approval of clinical study reports.
- Provides periodic status updates to Senior Management.
- Develops infrastructure and strategic planning to support advanced clinical trials.
- Establishes/implements regulatory strategy and manages submissions/interactions with FDA and other authorities.
- Maintains up-to-date knowledge of regulations, guidelines, and ICH-GCP.
- Other duties as assigned.
Requirements
- MS in Life Sciences/related field AND 15+ years industry experience in drug development/operations/strategic planning with Phase 1-4 clinical drug development; CRO experience plus; extensive managerial experience required.
- OR PharmD or PhD preferred AND 13+ years similar experience.
- OR MD plus AND 10+ years similar experience.
- Thought leader with technical and business expertise; strong interpersonal/communication, organizational leadership, analytical judgment, coaching/employee development.
- Ability to influence others; proactive problem-solving; cross-functional matrix experience.
- Extensive knowledge of clinical drug development (planning, regulatory requirements, study design, biostatistics, monitoring, data handling/analysis, report writing, data presentation) is mandatory.
- Expertise in submissions from IND through NDA and managing products from pre-clinical through all clinical phases and launch.
Benefits
- Retirement savings plan (with company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Compensation (base/bonus)
- Annual base salary: $243,100.00–$331,000.00; annual bonus target 35% of earned base salary; eligibility for equity-based long-term incentive program.
Responsible for leading development and execution on strategy and plans for Phase 1-3 clinical studies with a multidisciplinary team (R&D project teams, clinical project managers, statisticians, data management, regulatory, drug safety). Interfaces with Research, Translational and Experimental Medicine and Business Development to assess new product opportunities and develop clinical research strategy and product development plans.
Your Contributions (include, but are not limited to)
- Directs and provides strategic guidance for Phase 1-3 Clinical Trials in accordance with Neurocrine SOPs and GCP.
- Leads Clinical Development Plans and Study Protocols.
- Leads identification and selection of clinical investigators.
- Serves as point of contact and maintains professional relationship with Clinical Investigators.
- Assesses and disposes of adverse events and evaluates safety of clinical compounds.
- Leads selection of established and novel outcome measures.
- Oversees clinical trials program with Clinical Operations.
- Analyzes, interprets, and presents clinical study results.
- Leads and participates on multidisciplinary project teams.
- Identifies resources, leads budget planning and personnel forecasting.
- Recruits, trains, and develops clinical teams.
- Identifies/selects clinical consultants; collaborates with opinion leaders to ensure study design and data analysis success.
- Contributes to scientific writing, including review/approval of clinical study reports.
- Provides periodic status updates to Senior Management.
- Develops infrastructure and strategic planning to support advanced clinical trials.
- Establishes/implements regulatory strategy and manages submissions/interactions with FDA and other authorities.
- Maintains up-to-date knowledge of regulations, guidelines, and ICH-GCP.
- Other duties as assigned.
Requirements
- MS in Life Sciences/related field AND 15+ years industry experience in drug development/operations/strategic planning with Phase 1-4 clinical drug development; CRO experience plus; extensive managerial experience required.
- OR PharmD or PhD preferred AND 13+ years similar experience.
- OR MD plus AND 10+ years similar experience.
- Thought leader with technical and business expertise; strong interpersonal/communication, organizational leadership, analytical judgment, coaching/employee development.
- Ability to influence others; proactive problem-solving; cross-functional matrix experience.
- Extensive knowledge of clinical drug development (planning, regulatory requirements, study design, biostatistics, monitoring, data handling/analysis, report writing, data presentation) is mandatory.
- Expertise in submissions from IND through NDA and managing products from pre-clinical through all clinical phases and launch.
Benefits
- Retirement savings plan (with company match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Compensation (base/bonus)
- Annual base salary: $243,100.00–$331,000.00; annual bonus target 35% of earned base salary; eligibility for equity-based long-term incentive program.