Principal Scientist (Scientific Director Level)– Nonclinical Drug Safety

Merck & Co 5 Locations Updated 8 September 2026
PharmaBiotechPharmacovigilanceClinical ResearchRegulatory AffairsQuality Assuranceregulatory submissionemacroraveinformaws

Job description

Job Description Job Summary: We are seeking a Discovery Program Leader (DPL) to represent Nonclinical Drug Safety ( NDS ) on discovery research teams and in scientific and strategic review meetings focused primarily on immunology and oncology . This position requires exceptional leadership, collaboration, and independence, and a passion to work collaboratively across functions and sites to discover novel medicines that improve the lives of patients. The Discovery Program Leader is responsible for defining and overseeing the NDS strategy for programs in all modalities (including small molecule s , peptide s, biologics and ADC programs ) from Target Identification through to the approval of First-In-Human enabling GLP toxicity studies. They are responsible for 1) providing risk assessments for targets, 2) de-risking strategies for discovery programs and 3) collaborating with NDS staff at other sites to execute on the appropriate studies to support selection of therapeutic targets, and the identification and development of new drug candidates. The DPL may also serve on development teams with responsibility for defining the GLP toxicology study strategy and execution, and for the non-clinical safety sections of regulatory documents that support clinical trials and worldwide marketing authorization. In this role you will: Represent NDS on discovery teams and participate in therapeutic area discovery governance committee reviews. Promote and facilitate creative thinking from target identification/validation through lead optimization in Infectious Disease, Neuroscience, Immunology , Oncology , and/or Cardiometabolic Therapeutic Area s . Be a “drug creator” and promoter of innovative thinking by influencing both cross-site disease area aligned groups, as well as functional area disciplines. Identify and assess potential risks associated with therapeutic targets or development candidates using available literature, internal data, and external information. The individual may also lead early development teams, informing on preclinical studies to support product development. Qualifications, skills and experience needed: PhD in relevant field, DVM, MD degree or equivalent. Minimum 8 + years of demonstrated pharmaceutical industry experience as a non-clinical safety scientist (e.g. Toxicology, Pathology etc.) and/or as non-clinical safety assessment representative to a cross-functional development and/or discovery teams . Demonstrated ability to successfully navigate cross-functional lines and drive team decision making in a matrix organizational structure. Highly dedicated, motivated, resilient, and flexible; capable of creative problem solving and delivering on goals and objectives in a timely fashion. Excellent team player who can work collaboratively with discovery team members from various functions, other DPLs and scientist s responsible for study conduct and portfolio management. Excellent interpersonal skills, able to establish good working relationships within networks of employees of all levels. Excellent communicator who knows when and how to speak up, and appropriately raise issues to stakeholders and to management. Preferred experience: Experience with biopharmaceutical and small molecule pharmaceutical development and/or discovery. Experience with regulatory submissions and responses. Member of pharmaceutical consortia and/or external scientific or professional organizations. Required Skills: Clinical Safety, Finite Element Analysis (FEA), Good Lab Practices, Immuno-Oncology, Innovative Thinking, Matrix Management, Quality by Design, Regulatory Filings, Regulatory Submissions, Safety Management, Strategic Thinking, Technology Transfer, Toxicology Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of

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