Scientific Director, Clinical Pharmacology

Neurocrine Biosciences • San Diego, CA

2d

About The Position

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X and Facebook . ( in collaboration with AbbVie ) 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. Key member of clinical protocol development at all stages and ensures appropriate assessment of Clinical Pharmacology endpoints. Represents Preclinical Development & Clinical Pharmacology as expert to cross-functional project teams for assigned TA/Program, advises Sr. Technical Leadership and Executive Management [KL1.1][SB1.2]and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Clinical Pharmacology findings.

Requirements

• PhD in Pharmacokinetics, Pharmaceutical Sciences, or related field or PharmD AND 7+ years pharmaceutical/biotech experience; OR Master's in Pharmacokinetics, Pharmaceutical Sciences or closely related discipline AND 10+ years of relevant experience; OR Bachelor's in chemistry, life sciences or closely related discipline AND 12+ years of relevant experience
• Recognized as an internal thought leader and recognized expert in a therapeutic area/technology
• Ability to drive strategic direction into tactical plans
• Strong mentoring skills and leadership abilities to supervise junior scientists and/or lead indirect teams
• Innovator, drug hunter/developer
• Extensive knowledge of managing clinical Contract Research Organizations
• Proven track record in preparation of INDs, CTAs, NDAs, and MAAs
• Strong knowledge of pharmacometrics modeling and simulation tools
• Demonstrated knowledge on current regulatory guidance
• Ability to develop scientific insights from highly complex data sets; extensive knowledge of pharmacokinetic and pharmacodynamic data interpretation for clinical development compounds

Responsibilities

• Develops and executes Clinical Pharmacology scientific strategies for assigned TA, aligned with overall development plans
• Leads and manages the conduct, interpretation and reporting of pharmacokinetic (PK), pharmacodynamic (PD), and exposure–response activities for clinical development compounds
• Applies modeling and simulation approaches to inform study design, dose justification, and decision-making
• Oversees Clinical Pharmacology deliverables, including analysis plans, reports, and contribute to regulatory documents (e.g., INDs, CTAs, NDAs, BLAs, briefing books, Investigator Brochures)
• Represents Preclinical Development & Clinical Pharmacology on cross-functional program teams
• Communicates Clinical Pharmacology results and recommendations clearly to cross-functional teams and management, including preparation and delivery of scientific presentations
• Ensures Clinical Pharmacology activities are conducted in compliance with applicable SOPs, regulatory guidance, and internal standards
• Directs the resolution of highly complex or unusual business and scientific problems that impact success or address future processes / outcomes
• Regularly interacts with senior leadership to influence policy and negotiate decisions within area of responsibility
• Stays current with evolving regulatory expectations, scientific advancements, and industry best practices relevant to Clinical Pharmacology
• Leads and mentors junior scientists and/or team members
• Performs other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree