Principal Scientist (Scientific Director Level)– Nonclinical Drug Safety

Merck • San Diego, CA

1d • $176,200 - $277,300 • Hybrid

About The Position

The Principal Scientist (Scientific Director Level) serves as a Discovery Program Leader (DPL) representing Nonclinical Drug Safety (NDS) on discovery research teams and in scientific and strategic review meetings, primarily focused on immunology and oncology. The role requires leadership, collaboration, independence, and cross-functional, cross-site work to advance discovery of medicines that improve patients’ lives.

The DPL defines and oversees NDS strategy for programs across modalities—including small molecules, peptides, biologics, and antibody-drug conjugates—from target identification through approval of first-in-human-enabling GLP toxicity studies. The role provides target risk assessments, develops de-risking strategies for discovery programs, and collaborates with NDS colleagues at other sites to execute studies supporting therapeutic target selection and identification and development of drug candidates. The role may also serve on development teams, defining GLP toxicology study strategy and execution and preparing nonclinical safety sections of regulatory documents supporting clinical trials and worldwide marketing authorization.

The position represents NDS on discovery teams and therapeutic-area discovery governance committees; promotes creative thinking from target identification and validation through lead optimization; influences cross-site disease-area groups and functional disciplines; and identifies risks associated with therapeutic targets or development candidates using literature, internal data, and external information. The individual may also lead early development teams and advise on preclinical studies supporting product development.

The role is based primarily in West Point, Pennsylvania, with a hybrid work arrangement, a first-shift schedule, 10% travel, and domestic relocation indicated. Visa sponsorship is available.

Requirements

• PhD in a relevant field, DVM, MD, or equivalent degree.
• At least 8 years of pharmaceutical industry experience as a nonclinical safety scientist (such as in toxicology or pathology) and/or as a nonclinical safety assessment representative on cross-functional development or discovery teams.
• Demonstrated ability to navigate cross-functional relationships and drive team decision-making in a matrix organization.
• Highly dedicated, motivated, resilient, and flexible, with creative problem-solving skills and the ability to deliver goals and objectives in a timely manner.
• Ability to work collaboratively with discovery team members across functions, other DPLs, and scientists responsible for study conduct and portfolio management.
• Excellent interpersonal skills and ability to establish effective working relationships with employees at all levels.
• Excellent communication skills, including judgment about when and how to speak up and appropriately raise issues with stakeholders and management.
• Skills listed: 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, and Toxicology.

Nice To Haves

• Experience with biopharmaceutical and small-molecule pharmaceutical development and/or discovery.
• Experience with regulatory submissions and responses.
• Membership in pharmaceutical consortia and/or external scientific or professional organizations.

Responsibilities

• Represent Nonclinical Drug Safety on discovery teams and participate in therapeutic-area discovery governance committee reviews.
• Define and oversee NDS strategy for programs across modalities from target identification through approval of first-in-human-enabling GLP toxicity studies.
• Provide risk assessments for therapeutic targets and development candidates.
• Develop de-risking strategies for discovery programs.
• Collaborate with NDS staff at other sites to execute studies supporting therapeutic target selection and identification and development of drug candidates.
• Promote and facilitate creative thinking from target identification and validation through lead optimization in relevant therapeutic areas.
• Influence cross-site disease-area groups and functional-area disciplines to promote innovative thinking and drug creation.
• Use available literature, internal data, and external information to identify and assess potential risks associated with therapeutic targets or development candidates.
• Potentially serve on development teams, defining GLP toxicology study strategy and execution and contributing nonclinical safety sections of regulatory documents.
• Potentially lead early development teams and advise on preclinical studies supporting product development.

Benefits

• Medical, dental, vision, healthcare, and other insurance benefits for employees and their families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree