Distinguished Scientist, Safety Assessment Project Expert

Sanofi; Morristown (NJ); In loco; USD 180.000 - 250.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive compensation

Excellent benefits package

Descrizione del lavoro

Sanofi US Services in Morristown, NJ, is seeking a senior Preclinical Safety Scientist to join a dynamic group providing toxicology and safety pharmacology expertise on global projects. You will collaborate with project teams across the drug development value chain to shape nonclinical strategies.

Responsibilities include leading nonclinical safety studies, writing summaries for regulatory documents, reviewing data, and contributing to publications.

Competenze

• PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, or closely related field with 12+ years pharmaceutical industry experience.
• Demonstrated knowledge of GLP and ICH regulatory nonclinical testing requirements.
• Experience preparing and submitting IND and CTD submissions.
• Exceptional written and verbal communication and presentation skills.

Mansioni

• Serve as a Preclinical Safety Project Team Member on multi-functional R&D 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 and 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 reproductive and developmental toxicity studies.
• 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.

Conoscenze

GLP & ICH knowledge

IND/CTD submissions

Toxicology leadership

Communication skills

Formazione

PhD or DVM

Descrizione del lavoro

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.

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, or closely related field, with 12+ years of pharmaceutical industry experience in drug development and demonstrated experience in preclinical safety and toxicology.
• 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.
• Exceptional communication (written and verbal) and presentation skills with ability to present preclinical safety data in a project team setting and/or HA interactions.

Minimum Preferred Skills

• Experience as a GLP Study Director and/or Study Monitor.
• Experience in the conduct and interpretation of ophthalmology toxicity studies and data.
• Certification by the American Board of Toxicology is preferred but not required.

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’s 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.