Scientific Director, Clinical Pharmacology
Neurocrine Biosciences
2 months ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Develops and executes overall Clinical Pharmacology scientific strategies for assigned Therapeutic Area (TA). Oversees all aspects of Clinical Pharmacology activities for assigned clinical development compounds. Serves as a key member of clinical protocol development and ensures appropriate assessment of Clinical Pharmacology endpoints. Represents Preclinical Development & Clinical Pharmacology as an expert on cross-functional project teams for assigned TA/Program.
Your Contributions (include, but are not limited to)
- Develop and execute Clinical Pharmacology scientific strategies for assigned TA aligned with overall development plans
- Lead and manage PK/PD and exposure–response activities for clinical development compounds (conduct, interpretation, and reporting)
- Use modeling and simulation to inform study design, dose justification, and decision-making
- Oversee Clinical Pharmacology deliverables (analysis plans, reports) and contribute to regulatory documents (INDs, CTAs, NDAs, BLAs, briefing books, Investigator Brochures)
- Represent Preclinical Development & Clinical Pharmacology on cross-functional program teams
- Communicate results and recommendations clearly to cross-functional teams and management; prepare and deliver scientific presentations
- Ensure Clinical Pharmacology work complies with SOPs, regulatory guidance, and internal standards
- Resolve highly complex/unusual business and scientific problems impacting success and future processes/outcomes
- Stay current with evolving regulatory expectations and industry best practices
- Interact with senior leadership to influence policy and negotiate decisions
- Lead and mentor junior scientists/team members
- Perform other duties as assigned
Requirements
- PhD in Pharmacokinetics, Pharmaceutical Sciences (or related) or PharmD AND 7+ years pharmaceutical/biotech experience; OR
- Master’s in Pharmacokinetics/Pharmaceutical Sciences (or closely related) AND 10+ years relevant experience; OR
- Bachelor’s in chemistry/life sciences (or closely related) AND 12+ years relevant experience
- Recognized internal thought leader/expert in a therapeutic area/technology
- Ability to drive strategic direction into tactical plans
- Strong mentoring and leadership abilities
- Innovative drug hunter/developer
- Extensive knowledge managing clinical Contract Research Organizations
- Proven track record preparing INDs, CTAs, NDAs, and MAAs
- Strong pharmacometrics modeling and simulation tool knowledge
- Demonstrated knowledge of current regulatory guidance
- Ability to develop scientific insights from complex data; strong PK/PD data interpretation for clinical development
Benefits (as stated)
- Annual base salary: $192,500.00–$263,000.00; annual bonus target 35% of earned base salary; eligibility for equity long-term incentive
- Retirement savings plan (company match)
- Paid vacation, holiday, personal days
- Paid caregiver/parental and medical leave
- Health benefits: medical, prescription drug, dental, vision
Develops and executes overall Clinical Pharmacology scientific strategies for assigned Therapeutic Area (TA). Oversees all aspects of Clinical Pharmacology activities for assigned clinical development compounds. Serves as a key member of clinical protocol development and ensures appropriate assessment of Clinical Pharmacology endpoints. Represents Preclinical Development & Clinical Pharmacology as an expert on cross-functional project teams for assigned TA/Program.
Your Contributions (include, but are not limited to)
- Develop and execute Clinical Pharmacology scientific strategies for assigned TA aligned with overall development plans
- Lead and manage PK/PD and exposure–response activities for clinical development compounds (conduct, interpretation, and reporting)
- Use modeling and simulation to inform study design, dose justification, and decision-making
- Oversee Clinical Pharmacology deliverables (analysis plans, reports) and contribute to regulatory documents (INDs, CTAs, NDAs, BLAs, briefing books, Investigator Brochures)
- Represent Preclinical Development & Clinical Pharmacology on cross-functional program teams
- Communicate results and recommendations clearly to cross-functional teams and management; prepare and deliver scientific presentations
- Ensure Clinical Pharmacology work complies with SOPs, regulatory guidance, and internal standards
- Resolve highly complex/unusual business and scientific problems impacting success and future processes/outcomes
- Stay current with evolving regulatory expectations and industry best practices
- Interact with senior leadership to influence policy and negotiate decisions
- Lead and mentor junior scientists/team members
- Perform other duties as assigned
Requirements
- PhD in Pharmacokinetics, Pharmaceutical Sciences (or related) or PharmD AND 7+ years pharmaceutical/biotech experience; OR
- Master’s in Pharmacokinetics/Pharmaceutical Sciences (or closely related) AND 10+ years relevant experience; OR
- Bachelor’s in chemistry/life sciences (or closely related) AND 12+ years relevant experience
- Recognized internal thought leader/expert in a therapeutic area/technology
- Ability to drive strategic direction into tactical plans
- Strong mentoring and leadership abilities
- Innovative drug hunter/developer
- Extensive knowledge managing clinical Contract Research Organizations
- Proven track record preparing INDs, CTAs, NDAs, and MAAs
- Strong pharmacometrics modeling and simulation tool knowledge
- Demonstrated knowledge of current regulatory guidance
- Ability to develop scientific insights from complex data; strong PK/PD data interpretation for clinical development
Benefits (as stated)
- Annual base salary: $192,500.00–$263,000.00; annual bonus target 35% of earned base salary; eligibility for equity long-term incentive
- Retirement savings plan (company match)
- Paid vacation, holiday, personal days
- Paid caregiver/parental and medical leave
- Health benefits: medical, prescription drug, dental, vision