Senior/Executive Director, Non-Clinical Drug Safety Evaluation

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

PRIMARY FUNCTION

The Senior/Executive Director, Non-Clinical Drug Safety Evaluation is an experienced drug development scientist who will oversee nonclinical programs to support global HMP pipeline of products. Under the direction of the Senior Vice President of Global Pre-Clinical Safety and DMPK this individual will coordinate and manage various research, proof-of-concept and other non-clinical studies leading to regulatory filings, and provide support to the safety issues in clinical research. Experience in integrated strategic regulatory writing for small molecule programs and biologics programs, the leader must have the ability to facilitate effective cross-functional collaboration and coordination of activities with internal stakeholders and external groups such as academic or industry partners, vendors (CROs, etc.) are required.

MAJOR RESPONSIBILITIES AND DUTIES

The duties and responsibilities of the position include but are not limited to:

• Oversees and manages the global preclinical portfolio of studies for POC, pre-IND, CTA and IND submissions.
• Manage collaboratively the global nonclinical development programs and timelines with input from biometrics, nonclinical, clinical, quality, and regulatory teams.
• Design in vitro and in vivo toxicology studies (non-GLP and GLP) to support discovery and development efforts across global programs.
• Develop, review, and approve study protocols, test methods, study reports, and preclinical regulatory filings.
• Provide pharmacology and toxicology expertise in the analysis and interpretation of nonclinical results and integrate with the global development program.
• Author and review the nonclinical component of regulatory submissions with cross-functional data integration and contribution from SMEs.
• Communicate nonclinical safety findings to cross-functional teams with a balanced and clear point of view.
• Manage workload capacity and growth and supervise professional guidance for global preclinical scientists (contractors, employees) in the conduct of global preclinical studies.
• Prepare for and participate in regulatory interactions.
• Prepare scientific abstracts and manuscripts, and present information at scientific meetings to disseminate results of preclinical studies.
• Work with accounts payable and finance on non-clinical budgeting and forecasting for development programs
• Lead the nonclinical toxicity and safety evaluation committee to provide support for global discovery and development programs.

QUALIFICATIONS

• PhD in Pharmacology and/or Toxicology
• 10 years of experience in the pharmaceutical industry with track record of successful nonclinical regulatory submissions to FDA and EMA
• Abundant experience as toxicologist to support early drug discovery is preferred
• Extensive hands-on experience in designing and executing on nonclinical pharmacology and toxicology studies
• Strong practical knowledge of GLP and GMP requirements
• In-depth knowledge and first-hand experience of the regulatory environment (US and Europe and/or China) for drug development (preclinical and clinical)
• Small molecule and biologics including antibody and ADC, Oncology drug development experience
• Strong scientific writing skills and experience in preparation, strategy, design, writing and editing of regulatory documents (pre-IND packages, INDs, CTAs,) for global submissions
• Broad understanding of the regulatory process, including CMC, non-clinical and clinical and the various stages of clinical development of Oncology therapy products
• Excellent organizational, interpersonal skills, and ability to effectively communicate across internal multidisciplinary teams
• Integrity, teamwork, and commitment to excellence
• Fluent English and Mandarin are preferred
• Flexibility to travel frequently between US and China