Sr. Principal Scientist, Nonclinical Drug Safety
merck sharp dohme msdWest Point, PA
Sr. Principal Scientist, Nonclinical Drug Safety
merck sharp dohme msdWest Point, PA
today
Occupations
Natural Sciences ManagersMedical Scientists, Except EpidemiologistsRegulatory Affairs ManagersIndustries
Research and Development in BiotechnologyResearch and Development in the Physical, Engineering, and Life SciencesBiological Product ManufacturingAbout the role
Overview:
In this role you drive the nonclinical strategy for Immunology, aligning with NDS and the broader company mission in drug development and regulatory success. You provide scientific leadership, shape development plans, and manage risk assessments and regulatory submissions. You will influence external regulators and consortia while mentoring program leaders. This is a high-impact, cross-functional leadership position in a fast-paced, global setting. Compensation / Benefits medical, dental, vision retirement benefits (401(k)) annual bonus and long-term incentive paid holidays and vacation compassionate and sick days hybrid work arrangements
Responsibilities:
Lead immunology nonclinical programs and post-marketing support within NDS Provide scientific and strategic oversight with cross-functional teams (Discovery, Regulatory, Clinical, CMC) Develop high-quality nonclinical risk assessments and regulatory documents (IBs, INDs, NDAs, BLAs, MAAs) Mentor and develop Compound Leaders and Discovery Program Leaders Influence global regulatory strategy through publications, consortia, and cross-industry collaboration Proactively identify program risks, design nonclinical studies, and develop integrated safety development plans Oversee or conduct NDS due diligence for in-licensing opportunities relevant to Immunology Contribute to global nonclinical development strategy and internal policy improvements May serve as Compound Leader for assigned development compounds Foster a leadership culture balancing coaching, accountability, and talent growth
Key requirements:
PhD, DVM, and/or MD with graduate/post-graduate training in Toxicology, Immunology, Pharmacology, Pathology, or related field Minimum 12 years of experience in toxicology, immunology, pharmacology, or pathology with pharma program team experience Demonstrated regulatory experience with health authorities and GLP/compliance Proven collaboration and mentoring experience with program teams Strong analytical, scientific writing, and communication skills Experience authoring nonclinical sections of regulatory documents Strong leadership and people development Strategic thinking and influence in a matrixed environment Excellent written and verbal communication Immunology and/or immuno-oncology expertise Nonclinical drug development across discovery to late development Regulatory science and ICH guidelines
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JOB OVERVIEW
Experience level
Manager
Location
West Point, PA
Occupation
Natural Sciences Managers
Industry
Research and Development in Biotechnology
Posted
today
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