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Senior Director, Toxicology

Cambridge, MA

Posted: 01/11/2021 Employment Type: Direct Hire Job Category: Clinical: Scientific Job Number: 2705

Job Description

The Sr. Director of Toxicology will be responsible for comprehensive toxicology assessment of all pre-clinical and clinical product candidates. You will be a core member of the program teams providing toxicology expertise, planning, executing and evaluating toxicology assessments and delivering on data that promote program progression and de-risk product candidates. Our client is currently focused on small molecules as the therapeutic modality and oncology as the priority disease area of interest and in this role you will devise, drive, and implement (with internal collaborations and working with consultants/external partners) strategies and analyses necessary to evaluate the performance of development candidates, enable IND and NDA filings of product candidates and further contribute to the optimization of development programs. We are looking for a Board-certified toxicologist with extensive experience in the development of new molecular entities with leadership qualities.

  • Responsible for Preclinical Safety Assessment of development candidates.
  • Designs, implements, drives, and monitors toxicology strategies for portfolio assets.
  • Works with internal teams and external partners to execute on development program team objectives.
  • Contributes to development program strategy, study execution, data review/analysis, study reports, protocol preparation and regulatory document preparation; write and review non-clinical toxicology summary documents.
  • Oversees vendors and consultants as appropriate to execute on toxicology studies.
  • Leads toxicology contributions for all regulatory documents. Leads the resolution of toxicology-related queries from drug regulatory agencies, writing and reviewing responses to regulatory on toxicology-related queries.

  • PhD in Toxicology, Pharmaceutical Sciences, or related field is required.
  • A minimum of 10 years’ experience in the biopharma industry in a Toxicology role and proven ability to represent toxicology perspectives on project teams and with external partners.
  • Proficiency in the development of new molecular entities, especially with small molecules.
  • Track record of toxicology leadership on multiple Oncology development programs.
  • Experience with IND and NDA Oncology submissions and regulatory interactions.
  • Experience partnering with DMPK, Regulatory Affairs, Clinical, CMC and Translational Science colleagues to ensure comprehensive Toxicology approaches are developed as part of the program strategy.
  • Experience working cross-functionally and working with external partners.
  • Ability to perform in fast-paced, dynamic, constantly evolving environment.
  • Excellent communication and organizational skills and attention to detail.
  • Strong time management skills; ability to prioritize multiple tasks efficiently.

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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