Distinguished Scientist, Safety Assessment Project Expert

BioSpace; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Sanofi US Services seeks a senior toxicology scientific lead to oversee nonclinical safety programs for diverse drug candidates. You will design safety pharmacology and toxicology studies, author regulatory documents, and participate in integrated project teams with internal and external partners.

The role requires a PhD or DVM with 12+ years in the pharma industry, strong GLP knowledge, and experience preparing IND/CTD submissions.

Qualifications

• PhD or DVM with 12+ years pharma industry experience.
• Demonstrated knowledge of GLP and ICH policies.
• Experience preparing IND/CTD submissions.

Responsibilities

• Oversee nonclinical safety program across R&D candidates and projects.
• Write nonclinical summaries for regulatory documents (INDs, CTAs, NDAs/BLAs).
• Provide scientific leadership in nonclinical safety and reproductive toxicity interpretation.
• Prepare scientific publications/presentations from toxicology studies.
• Collaborate on external partnerships and internal project teams.

Skills

Presentation skills

Written communication

Education

PhD or DVM in biochemistry/toxicology/pharmacology/biology/physiology/pathology/statistics

Job description

Our Team

The candidate will be part of a dynamic interactive Preclinical Safety group that spans all aspects of the drug development value chain providing toxicology and safety pharmacology expertise as a member of global project teams. Given the activities performed by the group, internal (within Preclinical Safety and with other project functions) and external (collaboration partners) interactions occur on a daily basis making for a diverse work environment. You will

• Be exposed to all aspects of the drug development chain
• Have diverse opportunities to provide toxicology scientific input and apply those expertise
• Be recognized by Management and Project Teams for successes
• Receive excellent benefits and compensation.

Our Team

The candidate will be part of a dynamic interactive Preclinical Safety group that spans all aspects of the drug development value chain providing toxicology and safety pharmacology expertise as a member of global project teams. Given the activities performed by the group, internal (within Preclinical Safety and with other project functions) and external (collaboration partners) interactions occur on a daily basis making for a diverse work environment. You will

• Be exposed to all aspects of the drug development chain
• Have diverse opportunities to provide toxicology scientific input and apply those expertise
• Be recognized by Management and Project Teams for successes
• Receive excellent benefits and compensation.

As an overview, the incumbent will be responsible for oversight of the nonclinical safety program of Research and Development drug candidates. These activities entail formulating the nonclinical safety strategies, designing safety pharmacology and toxicology studies, authoring regulatory documents, being a member of an integrated Project Team, interacting with internal and external partners, and interacting with and responding to global regulatory agencies. In addition, you will review compounds for potential in-licensing opportunities and address nonclinical safety issues/risks for marketed products as other activities.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Are you ready to shape the future of medicine with us? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our safety team as a toxicologist and youll assure the safety, quality, purity and stability of Sanofi components and products, while enjoying lots of opportunities to broaden your experience and hone your skills.

Main Responsibilities

• Serve as a Preclinical Safety Project Team Member (PTM) on multi-functional Research and Development Project Teams on small molecules, biotherapeutics, oligonucleotides, and other modalities. Support the development of new products, develop and implement toxicology and safety pharmacology strategies. Support needed nonclinical safety activities for early-/late-stage development and Life Cycle Management/marketed products.
• Write nonclinical summaries for clinical Investigator Brochures, INDs, CTAs and NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents and or assist other PTMs in such activities as needed. Review reports and other documentation authored by internal personnel (e.g. Preclinical Safety, other Project Team functions) and/or external contract laboratories to provide the appropriate preclinical safety scientific perspective.
• Ensure high scientific standards in conducting and reporting of nonclinical safety and investigative toxicology studies. Provide scientific leadership within Preclinical Safety, particularly with experience in the conduct and interpretation of reproductive and developmental toxicity studies and data (preferred).
• Provide internal expertise for global nonclinical safety issues on various expert groups or internal committees as required. Prepare scientific publications and presentations from toxicology and safety pharmacology studies as appropriate.
• Participate in special projects or inter-industry working groups, as needed.
• Provide scientific input on design and analysis of R&D activities, including evaluations of external opportunities for in-licensing, and ensure activities are completed with highest scientific standards.

About You

Work Experience

• PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or related field, with 12+ years of pharmaceutical industry experience.
• Demonstrated knowledge and experience regarding GLP and ICH policies and understanding of regulatory nonclinical testing requirements.
• Demonstrated experience in preparing and submitting IND and CTD submissions.

Minimum Preferred Skills

• Experience as a GLP Study Director.
• Experience in the conduct and interpretation of ophthalmology toxicity studies and data.
• Certification by the American Board of Toxicology

Technical skills

Excellent presentation and writing skills

Language Requirements

English

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it is through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
• Be at the forefront of innovative drug development
• Be an integral member of global, multi-functional project teams

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.