Scientific Director, Toxicology
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-level Safety Pharmacology and Toxicology Development Strategies, represents Preclinical Development on Discovery and Development teams, and interfaces with internal and external colleagues to ensure timely dissemination of nonclinical safety findings. Authors and reviews regulatory submissions and meets with Health Authorities to support development candidates from First in Human through Phase 3 clinical trials and marketing applications. The role provides scientific and strategic leadership across assigned programs, manages preclinical CRO studies, advises teams and senior management on the potential impact of toxicology findings, and ensures regulatory toxicology work aligns with portfolio priorities. It also manages junior department members and helps oversee adherence to Toxicology SOPs.
Requirements
- PhD in Toxicology, Pathology, or a closely related discipline.
- 7+ years of pharmaceutical or biotech experience, including managing clinical Contract Research Organizations.
- Previous experience managing a group.
- Maintain knowledge of state-of-the-art scientific principles and theories through participation in Toxicology and biotech meetings and organizations, continuing education, and regular review of regulatory guidance, and apply that knowledge to guide Neurocrine’s scientific leadership.
- 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 within the organization.
- Good written and verbal communication skills.
- Ability to critically evaluate and summarize data and communicate it effectively.
- Ability to make 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 for assigned programs.
- Ensure regulatory Toxicology responsibilities align with portfolio priorities and assignments are completed on time.
- Manage 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 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 ensure timely and accurate dissemination of nonclinical safety study results to peers, program teams, and Neurocrine Management.
- Contribute to preparation of SOPs as needed to guide functional activities.
- Oversee regulatory toxicologists’ adherence to Toxicology SOPs.
- Maintain knowledge of current regulatory guidance, including ICH, EMA, and FDA guidance, related to preclinical development.
- Manage junior members of the department.
- Perform other tasks as assigned.
- Present scientific knowledge and results across the organization and to external parties.
- Drive strategic direction into tactical plans and lead multiple teams.
Benefits
- Retirement savings plan with company match
- Paid vacation
- Paid holidays
- Paid personal days
- Paid caregiver/parental leave
- Paid medical leave
- Medical coverage
- Prescription drug coverage
- Dental coverage
- Vision coverage
- Annual bonus with a target of 35% of earned base salary
- Eligibility to participate in an equity-based long-term incentive program
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
