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REMOTE - Sr Scientist, Toxicology

Company: Unassigned/Prospective Account
Location: San Diego
Posted on: September 16, 2021

Job Description:

An employer in the San Diego, CA area is looking for a Sr Scientist - Toxicology. The Sr. Scientist Toxicology will be responsible for designing, planning, monitoring, and reporting of exploratory and GLP toxicology and safety pharmacology studies. The candidate will have broad expertise in toxicology and safety pharmacology and provide nonclinical support for early to late stage programs.

· Plan, design, monitor, and interpret nonclinical studies required for IND and NDA submissions, including general toxicity, genotoxicity, carcinogenicity, reproductive and developmental, and juvenile studies

· Directly interface with contract research organizations (CROs) to provide input during protocol development and report finalization and monitor study activities to ensure timely and GLP compliant execution of contracted studies

· Represent Toxicology team on multi-disciplinary discovery and development program teams

· Critically evaluate toxicology findings and provide advice to project teams and senior management on potential impact of results on the program goals.

· Prepare safety pharmacology and toxicology sections of regulatory submissions (INDs, DSURs, IBs, and NDAs)

· Maintain a current understanding of toxicology literature, methodology, and regulatory requirements

- Authoring full NDA submissions
- PhD in toxicology or related discipline with at least 3 to 5 years of experience or BS/MS with 8+ years of experience.

- Experience working with/managing multiple CRO's or having experience working at a CRO

- An understanding of and experience with Good Laboratory Practices (US FDA 21 CFR Part 58) and working knowledge of FDA, EMA, and ICH guidance documents

- Experience in designing, monitoring, and interpreting non-GLP and GLP toxicology and safety pharmacology studies

- Strong communication and interpersonal skills with an ability to effectively function within a matrixed environment

- Excellent writing skills as they relate to preparation of reports and regulatory documents

- Experience authoring parts of NDA submissions

- Non Clinical Reproductive Toxicology Background for Risk Assessment

Keywords: Unassigned/Prospective Account, San Diego , REMOTE - Sr Scientist, Toxicology, Other , San Diego, California

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