Associate Director, Study Operations Manager - Nonclinical Toxicology

Added
1 hour ago
Type
Full time
Salary
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Related skills

regulatory affairs pharmacology fda toxicology safety pharmacology

πŸ“‹ Description

  • Oversee end-to-end operational management of nonclinical toxicology and safety pharmacology studies
  • Manage data flow between external research partners and internal teams, maintaining data accuracy
  • Initiate and coordinate statements of work (SOWs) with multiple CROs in collaboration with
  • Coordinate the preparation and internal review of draft study protocols and final reports with
  • Organize and track compound shipments in collaboration with CMC teams to ensure materials are
  • Monitor study progress remotely or on-site, proactively identifying operational challenges

🎯 Requirements

  • Bachelor's or Master's degree in Toxicology, Pharmacology, or a related scientific discipline.
  • At least six years of experience in the biotechnology or pharmaceutical industry, with hands-on
  • Strong understanding of biological sciences, nonclinical research methodologies, toxicology study
  • Demonstrated ability to coordinate multiple concurrent studies, manage competing priorities
  • Experience managing CRO relationships, coordinating statements of work, supporting protocol and
  • Familiarity with relevant global regulatory requirements and quality standards governing

🎁 Benefits

  • Annual base salary: $129,000–$231,000, depending on qualifications, experience, skills, and
  • Performance-based incentives: Eligibility for a company bonus based partly on organizational and
  • Retirement benefits: Access to a company-sponsored 401(k) plan and pension benefits, subject to
  • Healthcare coverage: Eligibility for medical, dental, vision, and prescription drug benefits.
  • Flexible benefits: Access to eligible flexible benefit programs, including healthcare and dependent
  • Insurance protection: Life insurance and death benefits, subject to the applicable plan provisions.
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