Director, Clinical Pharmacology

Research and Development              ·                US CA San Diego (On site)            ·           Full-time

Remote type: On-Site
Locations: US CA San Diego
Time type: Full time
Posted on: July 15, 2023
Job Requisition ID: R3905

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, but few options.

What We Do:

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

Develops strategic plans and objectives for area of responsibility, including working with Preclinical Pharmacokinetics/Metabolism colleagues and Pharmacometric colleagues to develop overall Clinical Pharmacology Development Strategies for subsequent ratification by project teams. Responsible for the analysis, interpretation and reporting of pharmacokinetic and pharmacodynamic data generated for Neurocrine’s clinical development compounds. Works with Neurocrine Clinical, Biostatistics and Regulatory colleagues, the Director, Clinical Pharmacology will participate in all stages of clinical protocol development to ensure appropriate assessment of Clinical Pharmacology endpoints. Represents Preclinical Development on Development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Clinical Pharmacology findings.

Your Contributions (include, but are not limited to):

• Leads and manages the conduct, interpretation and reporting of Clinical Pharmacology results
• Works with Development colleagues, develops Clinical Pharmacology development strategies
• Conducts Clinical Pharmacology analyses in support of Neurocrine’s clinical development compounds
• Oversees the preparation of Clinical Pharmacology sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.)
• Represents Preclinical Development on development-stage program teams
• Prepares data summaries and presents results to peers, colleagues, Neurocrine Management and regulatory agencies
• Prepares Standard Operating Procedures (SOPs) as needed to guide the Clinical Pharmacology activities
• 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
• Performs other duties as assigned

Requirements:

• Bachelor’s in chemistry, life sciences or closely related discipline and 15+ years of pharmaceutical/biotech experience. Experience in managing clinical Contract Research Organizations Experience with preparation of INDs, CTAs, NDAs, and MAAs Experience with in silico modeling and simulation tools is beneficial OR
• Master’s in Pharmacokentics, Pharmaceutical Sciences or closely related discipline and 13+ years of similar experience noted above OR
• PhD Pharmacokentics, Pharmaceutical Sciences or related field or PharmD and 10+ years of similar experience noted above
• Extensive knowledge of managing clinical Contract Research Organizations
• Excellent knowledge of activities/work required in preparation of INDs, CTAs, NDAs, and MAAs
• Working knowledge of in silico modeling and simulation tools
• Knowledgeable on current regulatory guidances
• Excellent knowledge of analysis, interpretation and reporting of pharmacokinetic and pharmacodynamic data generated for clinical development compounds
• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
• Ability to apply advanced analytical thought and judgment
• Strong leadership, coaching, employee development skills
• Ability to influence others with or without authority at all levels of the organization
• Proactive, innovative, with good problem-solving skills
• Ability to work in a cross functional team and matrix environment
• Excellent written, presentation, and verbal communication skills

#LI-SA1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $181,400.00-$263,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Please click here to apply.