Safety Assessment Compound Leader
Safety Assessment Compound Leader
Reporting to the VP of Safety Assessment, the Safety Assessment Compound Leader will be a member of multidisciplinary project teams. They will be responsible for defining and executing nonclinical safety strategies integrated with the overall project objectives to meet portfolio goals and stage-gate transitions. Close collaboration with the activities of other lines will be essential to achieve project team objectives and goals. In addition, the Safety Assessment Compound Leader will serve as a non-clinical Subject Matter Expert (SME) in collaboration with Regulatory, Pharmacovigilance, and Clinical groups on dossier preparation and responses to regulatory queries.
- Serve on Project Teams for development/discovery programs, and engage on all related aspects of the project e.g., efficacy assessment, compound de-risking, and clinical safety.
- Serve as study director on internal exploratory studies, and oversee the design, reporting and interpretation of exploratory and GLP-compliant studies that are outsourced.
- Domestic and international travel to monitor studies at contract research organizations will be expected
- Proactively attain knowledge of the target, awareness of the competition, and knowledge of global regulatory guidelines relevant to the project.
- Prepare drug safety portions for internal documents and present safety data and strategy to management and governance committees.
- Summarize safety studies for regulatory submissions, including components for IBs, clinical protocols, regulatory dossiers (IND/IMPD, NDA etc.) and regulatory query responses in collaboration with regulatory colleagues.
- Represent Safety Assessment function at project-related Regulatory Agency meetings (e.g., pre-IND, EOP-II, Pre- NDA)
- Issues management – work with internal colleagues and drug safety experts as appropriate, to develop de-risking strategies and resolve identified issues from non-clinical and clinical studies.
- Due diligence reviews for potential in-licensing candidates.
- Ph.D, DVM, or equivalent degree in a relevant scientific discipline. Candidates with BS/MS degrees and significant relevant working experience will be considered.
- Minimum of 5 years relevant experience directly supporting drug development project teams in an industrial setting (i.e. biopharmaceutical company or contract research organization).
- Minimum of 5 years of experience serving as a study monitor, study director or principal investigator for GLP safety assessment studies in applied research and development in pharma and/or mid-size/large biotech
- Demonstrated subject matter expertise in a specific area of non-clinical safety assessment (i.e. Pathology, Safety Pharmacology, Genetic Toxicology, Reproductive Toxicology or General Toxicology).
- Neuroscience drug development experience
Ph.D, DVM, or equivalent degree in a relevant scientific discipline. Candidates with BS/MS degrees will require minimum of 10 years of directly relevant working experience.
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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