Scientific Director, Toxicology

About the Role

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.

Your Contributions (include, but are not limited to)

• 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
• Knowledgeable of current regulatory guidance (eg ICH, EMA, FDA) related to preclinical development
• Manages junior members of department
• Other tasks as assigned

Requirements

• PhD in Toxicology, Pathology or closely related discipline and 7+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations
• Previous experience managing a group
• Maintains knowledge of state-of-the-art scientific principles and theories through participation in Toxicology and Biotech meetings and organizations, continuing education, regular review of regulatory guidance and applies such knowledge to guide Neurocrine's scientific leadership
• Grounded in state of the art practices, technologies and applications
• Excellent project, time, and problem solving skills
• Ability to communicate technical information and work with all levels within the organization
• Good written and verbal communication skills are required
• Ability to critically evaluate data, summarize data and effectively communicate it is required
• Ability to make effective presentations is required in both large and small groups
• Ability to communicate complex scientific and nonscientific issues to teams, executives and regulators is required
• Ability to understand published scientific literature outside of one's immediate area of expertise is required
• Ability to prepare manuscripts and other documents for regulatory submission is required
• Requires in-depth knowledge of the functional area, business strategies, and the company's goals
• Presents scientific knowledge/results across the organization and to external parties
• 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
• Sets broader picture and longer-term vision for scientific area / disease state
• Excellent project leadership skills