Job Description

Senior/Executive Director, Non-Clinical Drug Safety Evaluation

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Location: Florham Park, NJ (Preferred) / Shanghai, China

PRIMARY FUNCTION

The Senior/Executive Director, Non-Clinical Drug Safety Evaluation is an experienced drug development scientist responsible for overseeing nonclinical programs supporting the global HMP pipeline of products. Reporting to the Senior Vice President of Global Pre-Clinical Safety and DMPK, this individual will coordinate and manage research, proof-of-concept, and other non-clinical studies leading to regulatory filings, and support safety issues in clinical research. Experience in integrated strategic regulatory writing for small molecules and biologics is required. The leader must facilitate effective cross-functional collaboration with internal teams and external partners such as academic institutions, industry collaborators, and CROs.

MAJOR RESPONSIBILITIES AND DUTIES

The responsibilities include but are not limited to:

1. Managing the global preclinical portfolio for POC, pre-IND, CTA, and IND submissions.
2. Collaboratively managing global nonclinical development programs and timelines with various teams.
3. Designing in vitro and in vivo toxicology studies (non-GLP and GLP).
4. Developing, reviewing, and approving study protocols, test methods, reports, and regulatory filings.
5. Providing pharmacology and toxicology expertise for data analysis and interpretation.
6. Authoring and reviewing regulatory submission components with cross-functional input.
7. Communicating safety findings to teams clearly and effectively.
8. Supervising global preclinical scientists and managing workload capacity.
9. Participating in regulatory interactions.
10. Preparing scientific publications and presenting at scientific meetings.
11. Managing budgets and forecasting for non-clinical programs.
12. Leading the toxicity and safety evaluation committee for global programs.

QUALIFICATIONS

• PhD in Pharmacology and/or Toxicology.
• 10+ years of experience in the pharmaceutical industry with successful regulatory submissions.
• Experience supporting early drug discovery as a toxicologist preferred.
• Hands-on experience in designing and executing nonclinical pharmacology and toxicology studies.
• Strong knowledge of GLP and GMP requirements.
• Deep understanding of regulatory environments in US, Europe, and China.
• Experience with small molecules, biologics, antibodies, ADCs, and oncology drugs.
• Excellent scientific writing and regulatory document preparation skills.
• Broad understanding of drug development stages and regulatory processes.
• Strong organizational and communication skills.
• Integrity, teamwork, and commitment to excellence.
• Fluent in English; Mandarin preferred.
• Willingness to travel frequently between US and China.

Seniority level

• Director

Employment type

• Full-time

Job function

• Science and Other

Industries

• Biotechnology Research and Pharmaceutical Manufacturing

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