Sr. Director, Medical Director, DSPV (Drug Safety)

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:

We are excited to announce an exceptional opportunity for a talented individual to serve as our Sr. Director, Medical Director, DSPV (Drug Safety)! In this pivotal role, you will provide expert medical advice and counsel to our Senior Clinical leadership on safety and surveillance matters, while shaping the global safety and surveillance strategy for our innovative programs. Leading pharmacovigilance activities, including the analysis of safety data, detection and investigation of safety signals, and proactive risk management for both investigational and marketed compounds will be at the core of your responsibilities. Additionally, you will provide leadership and direction for signal management and aggregate report processes across various programs. If you are a visionary leader with a dedication to advancing drug safety and enhancing patient care, we invite you to bring your expertise to our dynamic team at Neurocrine!

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

• Provides medical leadership guidance to signal detection and risk management strategies for NBI investigational or marketed compounds

• Provides leadership guidance to aggregate safety reports for NBI investigational or marketed compounds

• Performs safety signal management-related activities to detect, analyze, and investigate safety signals

• Develops and manages risk strategies for Neurocrine products (all phases of development and post-approval)

• Serves as the product safety expert of designated indications or drug portfolio(s) and is accountable for managing the safety profile of the respective programs

• Manages ongoing product safety in support of the safety governance process

• Performs aggregate safety data review and interpretation to support safety evaluations

• Authors, reviews and provides input for drug-safety-related regulatory reports and clinical study documents (including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), MedDRA coding of AEs, product labeling, Company Core