Job Description

Responsible for overseeing the design, conduct, interpretation and reporting of Safety Pharmacology and Toxicology studies for assigned Discovery and Development programs. Collaborates with preclinical colleagues to develop overall Safety Pharmacology and Toxicology Development Strategies for assigned programs. Represent Preclinical Development on Discovery and Development teams and regularly interface with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings. Authors and reviews regulatory submissions and meets with Health Authorities to support clinical trials of Neurocrine development candidates from initiation of First in Human to phase 3 clinical trials and marketing applications. Drives the strategic scientific direction for assigned programs and other areas of responsibility. Leads the design, conduct, interpretation and timely reporting of Safety Pharmacology and Toxicology studies/data for assigned programs. Ensures regulatory Toxicology responsibilities are aligned with portfolio priorities and timely completion of all assignments. Manages studies at preclinical Contract Research Organizations (CROs) for assigned programs. Critically evaluate toxicology and safety pharmacology results, assess potential impact, communicate findings to management and provide strategic advice to project teams and senior management on potential impact of toxicology results on Program and Clinical/Regulatory strategy. Authors and reviews pharmacology and toxicology summaries for clinical and regulatory documents (IB, IND, CTA, NDA, briefing books, Investigator Brochures, periodic safety reports, etc.). Represents Preclinical Development on discovery and development teams. Regularly interfaces with internal and external scientists to ensure timely and accurate dissemination of nonclinical safety study results to peers, program teams and Neurocrine Management. Contribute to the preparation of SOPs as needed to guide functional activities. Oversees the adherence of regulatory toxicologists to all Toxicology SOPs. Manages junior members of department. Other tasks as assigned. Requirements: PhD or equivalent and 7+ years of relevant experience and previous experience managing a group. Requires in-depth knowledge of the functional area, business strategies, and the company’s goals. Ability to drive strategic direction into tactical plans. Ability to lead multiple teams. Strong leadership, mentoring skills and abilities typically supervises lower levels and/or leads indirect teams. Exceptional communications, problem-solving, analytical thinking, influencing skills. Excellent project leadership skills. Grounded in state of the art practices, technologies and applications. Excellent project, time, and problem solving skills. Good written and verbal communication skills. Ability to critically evaluate data, summarize data and effectively communicate. Ability to make effective presentations in both large and small groups. Ability to communicate complex scientific and nonscientific issues to teams, executives and regulators. Ability to understand published scientific literature outside of one’s immediate area of expertise. Ability to prepare manuscripts and other documents for regulatory submissions. Knowledgeable of current regulatory guidance (eg ICH, EMA, FDA) related to preclinical development. Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, 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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