As a Sr. Leader, executes the strategic direction of the Toxicology function. Ensures that toxicology studies and programs are conducted in accordance with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversees and evaluates protocol preparation for toxicology studies and reviews reports. Advises and directs the analysis, interpretation and reporting of Safety Pharmacology and Toxicology data for discovery and development programs. Designs and develops overall Safety Pharmacology and Toxicology development strategies for toxicology programs. Recommends longer term strategies to ensure effective achievement of strategic and operational objectives. Represents Preclinical development on discovery and development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings. Supports Sr. Leadership with in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.
Your Contributions (include, but are not limited to):
- 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 and proactively provides 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 (IND, CTA, NDA, briefing books, Investigator Brochures, etc.).
- 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 Company 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.
Requirements:
- PhD in Toxicology, Pathology or closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations.
- Exhibits ability to become 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 (including neuroscience and endocrinology) and regulatory regions including US, Canada, Europe and Japan.
- Expert knowledge of managing clinical Contract Research Organizations (CRO's).
- 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.
Unless noted above, applicants MUST be authorized to work in the US without Visa Sponsorship. US citizens and Green Card holders ONLY. We do not provide relocation assistance for those living outside the continental US. Please only click apply if you meet the specific requirements of the job listing, you are able to work in the location listed, and are comfortable with the salary range indicated above. Thanks for your interest. We look forward to working with you.
#J-18808-Ljbffr
