Scientific Director, Toxicology

Neurocrine Biosciences•San Diego, CA

About The Position

Oversees the design, conduct, interpretation, and reporting of Safety Pharmacology and Toxicology studies for assigned discovery and development programs. Collaborates with preclinical colleagues to develop program strategies and represents Preclinical Development on discovery and development teams. Works with internal and external colleagues to ensure timely and accurate communication of nonclinical safety findings. Authors and reviews regulatory submissions and meets with Health Authorities in support of clinical trials, from first-in-human studies through Phase 3 and marketing applications. The role also provides scientific direction and strategic advice, manages CRO studies and junior department members, and supports regulatory toxicology processes and functional activities.

Requirements

PhD in Toxicology, Pathology, or a closely related discipline.
Seven or more years of pharmaceutical or biotechnology experience, including managing clinical Contract Research Organizations.
Previous experience managing a group.
Maintain knowledge of state-of-the-art scientific principles and theories through professional meetings and organizations, continuing education, and regular review of regulatory guidance, and apply that knowledge to scientific leadership.
Knowledge of current regulatory guidance, such as ICH, EMA, and FDA guidance, related to preclinical development.
Knowledge of state-of-the-art practices, technologies, and applications.
Excellent project, time-management, and problem-solving skills.
Ability to communicate technical information and work with all levels of the organization.
Strong written and verbal communication skills.
Ability to critically evaluate and summarize data and communicate it effectively.
Ability to deliver effective presentations to large and small groups.
Ability to communicate complex scientific and nonscientific issues to teams, executives, and regulators.
Ability to understand published scientific literature outside one’s immediate area of expertise.
Ability to prepare manuscripts and other documents for regulatory submission.
In-depth knowledge of the functional area, business strategies, and company goals.
Ability to drive strategic direction into tactical plans and lead multiple teams.
Strong leadership and mentoring skills; typically supervises lower levels and/or leads indirect teams.
Exceptional communication, problem-solving, analytical-thinking, and influencing skills.
Ability to set a broader picture and longer-term vision for a scientific area or disease state.
Excellent project leadership skills.

Responsibilities

Drive the strategic scientific direction for assigned programs and other areas of responsibility.
Lead the design, conduct, interpretation, and timely reporting of Safety Pharmacology and Toxicology studies and data.
Ensure regulatory Toxicology responsibilities align with portfolio priorities and assignments are completed on time.
Manage studies at preclinical Contract Research Organizations (CROs).
Evaluate toxicology and safety pharmacology results, assess potential impact, communicate findings to management, and advise project teams and senior management on program and clinical/regulatory strategy.
Author and review pharmacology and toxicology summaries for clinical and regulatory documents, including IB, IND, CTA, NDA, briefing books, Investigator Brochures, and periodic safety reports.
Represent Preclinical Development on discovery and development teams.
Interface with internal and external scientists to disseminate nonclinical safety study results to peers, program teams, and Neurocrine management.
Contribute to preparation of SOPs as needed and oversee regulatory toxicologists’ adherence to Toxicology SOPs.
Manage junior members of the department.
Present scientific knowledge and results across the organization and to external parties.
Drive strategic direction into tactical plans and lead multiple teams.
Perform other tasks as assigned.