Distinguished Scientist, Safety Assessment Project Expert
About The Position
The Distinguished Scientist, Safety Assessment Project Expert will oversee the nonclinical safety program for Research and Development drug candidates. The role formulates nonclinical safety strategies; designs safety pharmacology and toxicology studies; authors regulatory documents; participates as a member of integrated project teams; and works with internal and external partners and global regulatory agencies. Other activities include reviewing compounds for potential in-licensing and addressing nonclinical safety issues and risks for marketed products. The position serves as a Preclinical Safety Project Team Member on multifunctional R&D teams working across small molecules, biotherapeutics, oligonucleotides, and other modalities. It supports new product development, early- and late-stage development, and life-cycle management. The role also provides scientific review and leadership, supports high standards for nonclinical safety and investigative toxicology studies, and prepares scientific publications and presentations as appropriate.
Requirements
- PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, or a closely related field.
- 12 or more years of pharmaceutical industry experience in drug development, with demonstrated experience in preclinical safety and toxicology.
- Demonstrated knowledge of and experience with GLP and ICH policies, and understanding of regulatory nonclinical testing requirements.
- Demonstrated experience preparing and submitting IND and CTD submissions.
- Exceptional written and verbal communication and presentation skills, including the ability to present preclinical safety data in project team settings and/or during health authority interactions.
Nice To Haves
- Experience as a GLP Study Director and/or Study Monitor.
- Experience conducting and interpreting ophthalmology toxicity studies and data.
- American Board of Toxicology certification is preferred but not required.
- Experience conducting and interpreting reproductive and developmental toxicity studies and data.
Responsibilities
- Serve as a Preclinical Safety Project Team Member on multifunctional R&D project teams across multiple drug modalities.
- Support development of new products and develop and implement toxicology and safety pharmacology strategies.
- Support nonclinical safety activities for early- and late-stage development and life-cycle management or marketed products.
- Write nonclinical summaries for Investigator Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents, and assist other project team members with these activities as needed.
- Review reports and other documentation from internal personnel and external contract laboratories, providing a preclinical safety scientific perspective.
- Ensure high scientific standards in the conduct and reporting of nonclinical safety and investigative toxicology studies.
- Provide scientific leadership within Preclinical Safety, particularly in reproductive and developmental toxicity studies and data.
- Provide internal expertise on global nonclinical safety issues through expert groups or internal committees as required.
- Prepare scientific publications and presentations based on toxicology and safety pharmacology studies as appropriate.
- Participate in special projects and inter-industry working groups as needed.
- Provide scientific input on the design and analysis of R&D activities, including evaluation of external in-licensing opportunities, and ensure activities meet high scientific standards.
- Interact with internal and external partners and global regulatory agencies, including responding to regulatory agencies.
Benefits
- Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Rewards package recognizing employee contributions.
- Opportunities for career growth, including promotion or lateral moves, domestically or internationally.
- Excellent benefits and compensation.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
