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

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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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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 Data Sheet (CCDS))

• Authors, reviews, and provides input to safety-related regulatory submission documents including periodic safety reports (e.g., DSUR, IND Annual Report, PADER, PBRER, PSUR, etc.) and responses to regulatory inquiries

• Performs medical review of individual case safety reports, including summarization, coding, seriousness, expectedness and Company causality assessment of investigational and/or marketed products

• Participates in multidisciplinary teams at Neurocrine involving R & D project teams, clinical project managers, business management, regulatory, and others to execute clinical trials, assess new product opportunities, develop clinical research strategy and product development plans

• Participates in developing processes and conventions for safety surveillance activities

• May have direct reports and be accountable for staff management and resource allocations, as needed

• Other duties as assigned

Requirements:

• M.D. degree plus accredited residency in relevant clinical specialty (eg, Internal Medicine, Family Practice, Neurology) and Board certification and clinical/industry experience required. 4+ years relevant experience. Experience in pharmacovigilance in a pharmaceutical (preferably) or biotechnology company with experience in signal management (e.g., signal detection, evaluation, assessment)

• Recognized Internal thought leader and deep expertise in a discipline

• Requires broad, deep and comprehensive expertise in leading-edge theories and techniques for functional area

• Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations

• Influences internal/external business and/or industry issues that have an impact on Neurocrine

• Strong mentoring skills and leadership abilities, may supervise lower levels and/or leads indirect teams

• Proven ability to translate strategy into tactical plans and drive outcomes

• Possesses industry-leading knowledge

• Excellent teamwork and interpersonal skills are required

• Excellent problem-solving, analytical thinking skills

• Sees broader picture, impact on multiple departments/divisions

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

• Excellent organizational and project management skills

• Exceptional accountability, interpersonal and organizational skills, and the ability to work in a cross-functional team environment

• Excellent project leadership skills

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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.

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