Immunology NDS Lead: Senior Principal Scientist

Merck & Co.; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Job summary

Merck & Co. in Rahway, NJ, seeks a senior leader to advance Nonclinical Drug Safety Immunology programs, overseeing nonclinical development and post-marketing support.

You will deliver high-quality strategies, coordinate regulatory submissions, mentor program leaders, and shape cross-functional collaboration with Discovery, regulatory affairs, and clinical development to sustain leadership in immunology drug development.

Qualifications

• Extensive experience in nonclinical drug development and regulatory interactions.
• Immunology focus with regulatory submissions know-how.
• Proven mentoring and program-team leadership.
• Strong GLP and ICH guideline knowledge.
• Ability to influence global regulatory strategy.
• Experience in immunology programs preferred.
• Leadership in matrixed R&D environments.

Responsibilities

• Lead NDS Immunology nonclinical strategy and risk assessments.
• Oversee regulatory submissions and risk assessments for global development.
• Mentor and develop Compound Leaders and program teams.
• Collaborate with Discovery, regulatory, and clinical functions to align strategies.
• Shape external scientific and regulatory environment through engagement with authorities and consortia.

Skills

Drug Development

Project Leadership

Risk Assessments

Strategic Planning

Toxicology

Pharmacodynamics

Pharmacokinetics

Mentorship

Cell Line Engineering

Omics Technologies

Product Registrations

Clinical Judgment

Innovative Thinking

Toxicity Studies

Education

PhD, DVM, or MD in Toxicology/Immunology

Job description

Merck & Co. in Rahway, NJ, seeks a senior leader to advance Nonclinical Drug Safety Immunology programs, overseeing nonclinical development and post-marketing support.

You will deliver high-quality strategies, coordinate regulatory submissions, mentor program leaders, and shape cross-functional collaboration with Discovery, regulatory affairs, and clinical development to sustain leadership in immunology drug development.