Scientific Director, Clinical Development - Endocrinology
Neurocrine Biosciences
3 months ago
Remote friendly (San Diego, CA)
United States
$187,900 - $256,000 USD yearly
Clinical Research and Development
About The Role
- Develop and execute clinical and translational strategy and program for compounds in development (scientific, clinical, and operational).
- Direct study design, protocol development, and execution of clinical research studies across all phases through registration (NDA/MAA).
- Lead end-to-end execution for assigned clinical projects in a timely and cost-effective manner.
- Interpret and report clinical study results; guide program teams on clinical data analysis and communication.
- Lead multidisciplinary teams through complex decisions integrating medical, scientific, regulatory, and commercial input.
- May participate in evaluation of business development, including licensing opportunities.
Your Contributions (include, But Are Not Limited To)
- Provide recommendations and expertise to study teams and functional areas (regulatory, clinical operations, line management).
- Design clinical development plans and study protocols.
- Identify assessments and develop novel outcome measures for early and late-stage trials.
- Manage development of target product profiles, development plans, Investigator’s Brochures, study concepts/protocols, study reports, and regulatory documents.
- Research relevant literature/competitor activities to optimize study design (population selection and clinical endpoints).
- Collaborate with opinion leaders, internal clinicians, translational sciences, and clinical operations to implement intended analyses and outcomes.
- Design trials from a patient-focused perspective; collaborate with patient advocacy groups.
- Drive critical decisions (e.g., critical success factors, go/no-go, dose selection).
- Develop translational plans for disease models and biomarkers; align clinical strategies for positioning and reimbursement.
- Align clinical plans/trial designs with real-world data (registries, claims, medical records).
- Support monitoring of study/program teams, deliverables, and study data accuracy/timeliness.
- Apply data analytics/data science before, during, and after studies (e.g., modeling, blinded analytics, post-hoc analysis).
- Monitor investigator adherence to protocols, regulatory requirements, and GCP; contribute to data validation plans.
- Monitor sites and audit facility selection (including site visits as needed).
- Implement best regulatory practices and drug development precedent; recommend regulatory documents for filings and agency meetings.
- Review competitor landscape; proactively identify issues and recommend solutions.
- Direct preparation of abstracts, manuscripts, and presentations; author clinical sections of regulatory documents (IB, IND sections).
- Maintain expertise on pharmaceutical regulations, guidelines, and ICH-GCP.
- Liaise with bioanalytical labs, pharmacokinetic scientists, biomarker representatives, and data managers for PK/PD and safety data.
- Liaise with statisticians/programmers to develop and implement statistical analysis plans.
- Evaluate/select research centers and investigators; lead clinical support for Regulatory Affairs.
- Collaborate with safety/responsible physicians on adverse events, patient eligibility, and protocol deviations.
- Provide guidance on interpretation/reporting of results; present to internal/external audiences.
- Prepare presentations and medical publications.
- Create and manage budgets for project-related activities.
- Conduct subject eligibility review; mentor/develop clinical team members.
- Other duties as assigned.
Requirements
- BS/BA in Biology, Chemistry, or related science + 15+ years relevant experience
OR
- Master’s in Biology, Chemistry, or related science + 13+ years related experience
OR
- PhD (or equivalent combination of education and work experience) + 7+ years related experience
Qualifications / Skills
- Knowledge of best practices in functional discipline; familiarity with related business concepts.
- Ability to formulate, develop, and execute clinical strategies.
- Ability to improve tools/processes within the function.
- Ability to work as part of and lead multiple teams; leadership of lower levels/indirect teams.
- Excellent communications, problem-solving, analytical thinking.
- Ability to see broader picture/impact across departments.
- Ability to meet multiple deadlines with high accuracy/efficiency.
- Excellent project management; strong computer literacy.
- Applies data/research findings to new scientific projects.
- Maintains substantial knowledge of scientific principles/theories; intellectual mastery in one or more scientific areas.
- Advanced knowledge/ability working with and recommending a variety of laboratory equipment/tools.
- Strong track record in translational neuroscience research.
- Experience developing medicines for Mood Disorders, Schizophrenia, and other psychiatry diseases.
- Experience designing and conducting Phase I/2/3 studies in Neuroscience.
Benefits
- Annual base salary: $187,900.00–$256,000.00.
- Annual bonus (target 35% of earned base salary) and eligibility for equity-based long-term incentive.
- Retirement savings plan (with company match), paid vacation/holidays/personal days.
- Paid caregiver/parental and medical leave.
- Health benefits including medical, prescription drug, dental, and vision coverage.
Application Instructions
- Encourage candidates to apply even if experience/qualifications do not fully match the job description.
- Develop and execute clinical and translational strategy and program for compounds in development (scientific, clinical, and operational).
- Direct study design, protocol development, and execution of clinical research studies across all phases through registration (NDA/MAA).
- Lead end-to-end execution for assigned clinical projects in a timely and cost-effective manner.
- Interpret and report clinical study results; guide program teams on clinical data analysis and communication.
- Lead multidisciplinary teams through complex decisions integrating medical, scientific, regulatory, and commercial input.
- May participate in evaluation of business development, including licensing opportunities.
Your Contributions (include, But Are Not Limited To)
- Provide recommendations and expertise to study teams and functional areas (regulatory, clinical operations, line management).
- Design clinical development plans and study protocols.
- Identify assessments and develop novel outcome measures for early and late-stage trials.
- Manage development of target product profiles, development plans, Investigator’s Brochures, study concepts/protocols, study reports, and regulatory documents.
- Research relevant literature/competitor activities to optimize study design (population selection and clinical endpoints).
- Collaborate with opinion leaders, internal clinicians, translational sciences, and clinical operations to implement intended analyses and outcomes.
- Design trials from a patient-focused perspective; collaborate with patient advocacy groups.
- Drive critical decisions (e.g., critical success factors, go/no-go, dose selection).
- Develop translational plans for disease models and biomarkers; align clinical strategies for positioning and reimbursement.
- Align clinical plans/trial designs with real-world data (registries, claims, medical records).
- Support monitoring of study/program teams, deliverables, and study data accuracy/timeliness.
- Apply data analytics/data science before, during, and after studies (e.g., modeling, blinded analytics, post-hoc analysis).
- Monitor investigator adherence to protocols, regulatory requirements, and GCP; contribute to data validation plans.
- Monitor sites and audit facility selection (including site visits as needed).
- Implement best regulatory practices and drug development precedent; recommend regulatory documents for filings and agency meetings.
- Review competitor landscape; proactively identify issues and recommend solutions.
- Direct preparation of abstracts, manuscripts, and presentations; author clinical sections of regulatory documents (IB, IND sections).
- Maintain expertise on pharmaceutical regulations, guidelines, and ICH-GCP.
- Liaise with bioanalytical labs, pharmacokinetic scientists, biomarker representatives, and data managers for PK/PD and safety data.
- Liaise with statisticians/programmers to develop and implement statistical analysis plans.
- Evaluate/select research centers and investigators; lead clinical support for Regulatory Affairs.
- Collaborate with safety/responsible physicians on adverse events, patient eligibility, and protocol deviations.
- Provide guidance on interpretation/reporting of results; present to internal/external audiences.
- Prepare presentations and medical publications.
- Create and manage budgets for project-related activities.
- Conduct subject eligibility review; mentor/develop clinical team members.
- Other duties as assigned.
Requirements
- BS/BA in Biology, Chemistry, or related science + 15+ years relevant experience
OR
- Master’s in Biology, Chemistry, or related science + 13+ years related experience
OR
- PhD (or equivalent combination of education and work experience) + 7+ years related experience
Qualifications / Skills
- Knowledge of best practices in functional discipline; familiarity with related business concepts.
- Ability to formulate, develop, and execute clinical strategies.
- Ability to improve tools/processes within the function.
- Ability to work as part of and lead multiple teams; leadership of lower levels/indirect teams.
- Excellent communications, problem-solving, analytical thinking.
- Ability to see broader picture/impact across departments.
- Ability to meet multiple deadlines with high accuracy/efficiency.
- Excellent project management; strong computer literacy.
- Applies data/research findings to new scientific projects.
- Maintains substantial knowledge of scientific principles/theories; intellectual mastery in one or more scientific areas.
- Advanced knowledge/ability working with and recommending a variety of laboratory equipment/tools.
- Strong track record in translational neuroscience research.
- Experience developing medicines for Mood Disorders, Schizophrenia, and other psychiatry diseases.
- Experience designing and conducting Phase I/2/3 studies in Neuroscience.
Benefits
- Annual base salary: $187,900.00–$256,000.00.
- Annual bonus (target 35% of earned base salary) and eligibility for equity-based long-term incentive.
- Retirement savings plan (with company match), paid vacation/holidays/personal days.
- Paid caregiver/parental and medical leave.
- Health benefits including medical, prescription drug, dental, and vision coverage.
Application Instructions
- Encourage candidates to apply even if experience/qualifications do not fully match the job description.