Sr. Scientific Director, Toxicology

Neurocrine Biosciences • San Diego, CA

3d

About The Position

As a Sr. Leader, leads and executes the scientifically sound and regulatory authority-acceptable toxicology strategies that support safety assessments for a Research and Development portfolio spanning early drug discovery through clinical development and market authorization. Recommends longer term strategies to ensure effective achievement of strategic and operational objectives. Oversees the safety pharmacology and toxicology studies including protocol design, advises and directs the execution, data interpretation, and review of reports for new therapeutic entities of various modalities (small molecules, large molecules, peptide conjugates, oligonucleotides, and gene therapies). Ensures that toxicology studies and programs are conducted in accordance with the appropriate guidelines and regulatory test standards (FDA, ICH, WHO, GLP, and ISO). Represents Toxicology and work closely with Research and Development functions to integrate toxicology strategies into the research/development plan, provide scientific insight into the safety profile, and de-risk potential safety liabilities. Supports Sr. Leadership with in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.

Requirements

• PhD in Toxicology, Pathology or closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations
• D.V.M. and 8+ years of similar experience noted above
• Expert knowledge in development of various modalities, especially Biotherapeutics (bispecific or trispecific antibodies, BBB shuttles, peptide conjugates), oligonucleotides, and gene therapies desired
• Demonstrated experience in the preparation of INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures
• Expert in regulatory strategies for various modalities in US, Canada, and Europe
• Demonstrate strategy development and implementation within areas of responsibility
• Expert knowledge of global Good Laboratory Practices and Health Authority requirements for nonclinical safety data that support clinical trials and market authorization of investigational medicinal products
• Extensive experience in managing clinical Contract Research Organizations (CRO's)
• Exhibits ability to become company-wide advisor and emerging industry expert.
• 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
• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas

Responsibilities

• Develops, implements and directs the scientifically sound and regulatory authority-acceptable toxicology strategies that support safety assessments for a R&D portfolio spanning early drug discovery through clinical development and market authorization
• 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 safety pharmacology and toxicology results and proactively provides strategic direction to project teams and senior management on the potential impact of results on Program and Clinical/Regulatory strategy
• Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures, etc.)
• Represents Toxicology and work closely with R&D functions to integrate toxicology strategies into the research/development plan, provide scientific insight into the safety profile, and de-risk potential safety liabilities
• 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
• Oversees the adherence of regulatory toxicologists to all Toxicology SOPs
• Maintains current knowledge of regulatory guidance, industry standards and recommendations
• Participates in the selecting, developing and evaluating personnel to ensure the efficient operation within the toxicology group
• Other tasks as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees