Sr. Scientist, Clinical Pharmacology

 San Diego, CA    ·    Full-time

Location/s: US CA San Diego
Time Type: Full time
Job Requisition ID: R3426

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:

As a key member of the Preclinical Development group at Neurocrine Biosciences, this individual will provide oversight of Clinical Pharmacology activities. Responsible for the analysis, interpretation and reporting of pharmacokinetic and pharmacodynamic data generated for assigned clinical development programs. Working with Neurocrine Clinical, Biostatistics and Regulatory colleagues, participate in all stages of clinical protocol development to ensure appropriate assessment of Clinical Pharmacology endpoints. Works with Preclinical Pharmacokinetics/Metabolism and Pharmacometric colleagues to develop overall Clinical Pharmacology Development Strategies for subsequent ratification by project teams. Represent Preclinical Development on Development teams and regularly interface with internal and external colleagues to ensure timely and accurate dissemination of Clinical Pharmacology findings.

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

• Support planning, design, initiation, and conduct studies with Clinical pharmacology endpoints
• Lead analysis of pharmacokinetic and pharmacodynamic data in preparation for final reporting and interpretation in support of Neurocrine’s clinical development compounds. data
• Prepares data summaries and presents results to peers, colleagues, Neurocrine Management and regulatory agencies
• Contributes to Clinical Pharmacology sections of regulatory documents (e.g., IND, NDA, briefing books, Investigator Brochures, etc.)
• Works with Preclinical Development colleagues, develops Clinical Pharmacology development strategies
• Responsible for ensuring compliance with good laboratory practices and other regulatory guidelines
• Prepare SOPs as needed to guide the Clinical Pharmacology activities
• Other tasks as assigned

Requirements:

• PhD with emphasis in pharmacokinetics, clinical pharmacology, or a related scientific discipline and 1+ years experience in clinical-stage pharmaceutical development (3+ years desirable)
• Master’s degree with 5+ years or Bachelor’s degree with 7+ years with similar experience noted above will be considered
• In-depth knowledge of pharmacokinetic and other analysis software programs (e.g., WinNonlin, GraphPad, etc.)
• Familiarity with all stages of drug development with experience in preparation of INDs, CTAs, NDAs, MAAs
• Familiarity within silico modeling and simulation tools is beneficial
• Ability to work in a cross-functional team and matrix environment
• Excellent written, presentation, and verbal communication skills

#LI-DM1

​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 $103,200.00-$165,200.00. 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 20% 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.