Nonclinical Scientist
2000 Regency Pkwy Suite 500 Cary, NC 27518 US
Job Description
Seeking a highly motivated nonclinical scientist with a strong foundation in animal and/or biomedical sciences, including toxicology, pathology and physiology with proficient knowledge of developmental and reproductive biology. Will lead safety and reproductive toxicology assessments of small molecules and biologics; providing the findings in investigational new drug (IND), new drug application (NDA) or Marketing Authorization Application (MAA) programs; and helping to define preclinical sections of these submissions with regulatory authorities.
SUMMARY OF KEY RESPONSIBILITIES · Overseeing all aspects of the conduct of pre-clinical studies, including synopsis and protocol development, GLP and SOP compliance, interpretation of results, and issuance of the final report.
· Design and monitor contracted in vitro or in vivo pharmacokinetic and toxicity animal studies to meet specific project team goals and regulatory requirements.
· Facilitate study initiation by executing appropriate processes for contract implementation, test article procurement, protocol development, and timeline commitments.
· Monitor studies for appropriate conduct, accuracy, and timely completion; audit raw data for accuracy; and review draft reports for completion.
· Evaluate individual and programmatic study data (anatomic pathology, clinical pathology, in-life parameters, etc.) as to the potential toxicity of experimental compounds in different animal species and prepare verbal and written summaries for internal discussions.
· Work as part of an interdepartmental and multidisciplinary team in acquisition and evaluation of study materials, coordination of all study activities, and interpretation and reporting of pre-clinical studies results,
· Serve as a key resource, providing scientific knowledge and expertise to cross-functional project teams.
· Contribute to various regulatory documents and ensure regulatory compliance.
· Build strong collaborative relationships with research and development teams to meet project, departmental, and company goals.
REQUIRED QUALIFICATIONS AND SKILLS · PhD in a relevant field of study (e.g., toxicology, pharmacology) with experience in animal research; Optional Board Certification in toxicology (DABT) plus or minus DVM degree.
· 5-10 plus years of experience in the pharmaceutical industry (including CRO) with a proven track record of success in conducting drug safety and reproductive toxicology assessment studies
· Solid foundation in animal and/or biomedical sciences, including toxicology, pathology, and physiology with proficient knowledge of developmental and reproductive biology
· Excellent written and oral communication skills
· In vivo study director experience preferred.
· Technical writing proficiency preferred.
· Direct experience with Good Laboratory Practices (21 CFR Part 58) preferred.
· Strong commitment to quality and accountability
· Data-driven decision-making
· Strong organizational and project management skills
· Effective problem-solving skills and judgment
· Able to work in a strong collaborative environment.
· Ability to support projects and the work of interdisciplinary team members.
· Strong interpersonal skills, with the ability to build credibility and trust with internal and external stakeholders.
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