Immunology NDS Leader: Nonclinical Safety & Strategy

Merck; West Point (PA); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Sick days and other insurance benefits

Job summary

Merck & Co., Inc. seeks a senior Nonclinical Drug Safety Therapeutic Area Leader (Immunology) to advance immunology programs from discovery through registration.

You will shape nonclinical strategy, coordinate cross‑functional teams, and mentor leaders to ensure high‑quality risk assessments and regulatory submissions. We value strong scientific acumen, leadership in matrix environments, and a track record across multiple drug development phases, with emphasis on immunology programs and

Qualifications

• PhD, DVM, or MD with graduate/post‑graduate training in toxicology, immunology, pharmacology, pathology, or related field.
• Minimum 12 years of experience in toxicology/immunology/pharmacology with pharma program team work and regulatory exposure.
• Experience mentoring program team members and collaborating across cross‑functional groups.
• Solid experience with regulatory processes, nonclinical risk assessments, ICH guidelines, and GLP.

Responsibilities

• Lead nonclinical immunology programs and provide strategic oversight across discovery to late development.
• Deliver nonclinical strategies, risk assessments, and regulatory submissions for global development.
• Mentor and develop Compound Leaders and program teams within a matrixed organization.
• Influence regulatory strategy through publications, consortia, and cross‑industry collaboration.
• Provide risk‑balanced decision making and timely issue resolution in complex programs.

Skills

Cell Line Engineering

Clinical Judgment

Drug Development

Human Health Risk Assessment

Innovative Thinking

Mentorship

Omics Technologies

Pharmacodynamics

Pharmacokinetics

Product Registrations

Project Leadership

Risk Assessments

Strategic Planning

Toxicity Studies

Toxicology

Education

PhD, DVM, and/or MD in Toxicology/Immunology/Pharmacology/Pathology

Job description

Merck & Co., Inc. seeks a senior Nonclinical Drug Safety Therapeutic Area Leader (Immunology) to advance immunology programs from discovery through registration.

You will shape nonclinical strategy, coordinate cross‑functional teams, and mentor leaders to ensure high‑quality risk assessments and regulatory submissions. We value strong scientific acumen, leadership in matrix environments, and a track record across multiple drug development phases, with emphasis on immunology programs and