Associate Director Project Toxicologist (Cambridge)

Compensation

: $98,940.00 - $163,430.00 /year *

Employment Type

: Full-Time

Industry

: Executive Management



Your role:

To provide high quality expertise on preclinical safety (Toxicology and Safety Pharmacology) to Global Product Teams (GPTs).You are accountable for the management of pharma projects (small molecules and biologics) beginning at Exploratory Development (ED) through marketing authorization and life cycle management (LCM). To analyze results of in silico, in vitro and in vivo toxicology as well as safety pharmacology studies and bibliographic data, put it into strategic perspective and create preclinical safety assessments.

You will compile preclinical safety parts of all regulatory documents including clinical trial applications (IND/IMPDs), global marketing authorization applications (e.g. BLA/NDA) and other filings. To support delivery of high-quality contributions in incoming requests from other functions within the organization and Health Authorities. You will contribute to activities for due diligence evaluations.

Who you are:

Minimum qualifications:

  • Bachelors degree with 8+ years of experience, masters degree with 3+ years of experience, or PhD degree in biology, chemistry, pharmaceuticals, or related field
  • Preferred qualifications:

  • Advanced scientific degree, DVM, PhD in life science (Toxicology, Biology, Physiology) preferred
  • Toxicology Board (ABT) certification or certification in Pharmacology and Toxicology advantageous
  • At least 10 years experience within apharmaceutical project environment preferred
  • Detailed knowledge of preclinical toxicology and safety pharmacology, R&D processes and regulatory requirements
  • Broad experience in health authority interactions
  • Excellent project management and analytical skills
  • * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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