Scientific Director/Sr. Scientific Director for Toxicology
1 week ago
About Us:
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. We have a strong, inclusive, and positive culture based on our shared purpose and values.
Role Overview:
This Senior Leadership role will oversee the strategic direction of the Toxicology function, ensuring that toxicology studies and programs are conducted in accordance with relevant guidelines and regulatory test standards. The ideal candidate will have a PhD in Toxicology, Pathology, or a closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations.
Key Responsibilities:
- Develops, implements, and directs toxicology strategies to support assigned discovery and development programs.
- Supports planning and execution of Safety Pharmacology and Toxicology studies/data for all programs.
- Oversees and directs assignments within the regulatory Toxicology function to ensure timely completion of priority activities.
- Evaluates, interprets, and summarizes toxicology results, providing strategic direction to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy.
- Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents.
- Represents Preclinical Development on discovery and development-stage program teams.
- Provides strategic oversight and direction for the preparation of data summaries and contributes to the presentation of results to peers, colleagues, and Neurocrine Management.
- Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to SOPs.
- Maintains current knowledge of regulatory guidance, industry standards, and recommendations.
- Participates in the selecting, developing, and evaluating personnel to ensure efficient operation within the toxicology group.
Requirements:
- PhD in Toxicology, Pathology, or a closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations.
- Exhibits ability to become a company-wide advisor and emerging industry expert.
- Demonstrated strategy development and implementation within areas of responsibility.
- Possesses expert knowledge of own function and broad knowledge of multiple functions and impact on business.
- Proven leadership skills and ability, including influencing across many levels of the organization.
- Expert knowledge of drug development strategies for various modalities, including small molecules, biologics, therapeutic peptides, therapeutic areas, and regulatory regions.
- Expert knowledge of managing clinical Contract Research Organizations (CROs).
- Demonstrated experience in the preparation of INDs, CTAs, NDAs, and MAAs.
- Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas.
What We Offer:
We offer an annual base salary of $217,300.00-$314,725.00, 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 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.
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San Diego, California, United States Neurocrine Biosciences Full timeAbout the RoleWe are seeking an exceptional Scientific Director/Sr. Scientific Leader, Drug Safety Expert to join our team at Neurocrine Biosciences.This is a unique opportunity for a highly experienced and accomplished professional in toxicology to lead our drug safety efforts and contribute to the development of life-changing treatments for patients with...
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