Immunology Nonclinical Safety Strategy Lead

MSD Malaysia; Northern (KY); Hybrid; USD 191,000 - 300,000; Full time

Job summary

MSD Malaysia is seeking an experienced NDS Therapeutic Area Leader for Immunology to guide nonclinical development across immunology programs. You will deliver high‑quality strategies, align discovery and regulatory teams, and shape external scientific engagements to support global clinical development and post‑marketing commitments.

The role requires deep immunology expertise, strong regulatory acumen, and a track record in leading cross‑functional teams.

Qualifications

• PhD, DVM, and/or MD with graduate/post-graduate training in Toxicology, Immunology, Pharmacology, Pathology, or related field.
• Minimum 12+ years in toxicology/immunology/pharmacology with pharma program leadership and regulatory experience.
• Experience mentoring program team representatives and collaborating across functions.
• Regulatory experience with health authorities, ICH/GLP knowledge, and nonclinical documentation.
• Strong leadership, strategic thinking, and excellent scientific communication.

Responsibilities

• Serve as NDS Therapeutic Area Leader for Immunology, overseeing nonclinical programs and post‑marketing support.
• Provide strategic oversight for immunology candidates and collaborate with program leaders and discovery teams.
• Develop high‑quality nonclinical strategies, risk assessments, and regulatory submissions.
• Influence external scientific and regulatory environment through engagement with authorities and consortia.
• Mentor and coach compound leaders and discovery program leaders for growth and program success.
• Foster a culture of coaching, empowerment, accountability, and talent development.
• Plan resources, priorities, and risks across immunology programs and address safety considerations.
• Lead nonclinical strategy inputs for safety, weight‑of‑evidence assessments, and integrated safety plans.
• Ensure robust regulatory documentation for IBs, INDs, NDAs, BLAs, MAAs, and responses.
• Collaborate with discovery and regulatory functions to advance projects across modalities.
• Lead cross‑departmental initiatives to improve policies and strategic direction.
• May serve as a Compound Leader for development compounds and conduct due diligence.
• Build external reputation through immunology leadership and scientific contributions.

Skills

Immunology expertise

Leadership

Regulatory strategy

Nonclinical development

Mentorship

Scientific communication

Education

PhD/ DVM/ MD

Job description

MSD Malaysia is seeking an experienced NDS Therapeutic Area Leader for Immunology to guide nonclinical development across immunology programs. You will deliver high‑quality strategies, align discovery and regulatory teams, and shape external scientific engagements to support global clinical development and post‑marketing commitments.

The role requires deep immunology expertise, strong regulatory acumen, and a track record in leading cross‑functional teams.