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Director of Toxicology

4 months ago

Cambridge, Massachusetts, United States BlueRock Therapeutics Full time

Director of Toxicology leads nonclinical safety within Preclinical Development and is responsible for coordinating nonclinical safety to adequately support BlueRock programs from research through development stages. Working across numerous functional groups and testing facilities, the position is accountable for all phases of nonclinical safety of human induced pluripotent stem cell (hiPSC)-derived authentic cells prior to initiating clinical trials. Director of Toxicology assures adequate strategy for nonclinical IND-enabling studies in conjunction with program teams to support clinical testing and provides input as a technical expert within the immediate function and within a multidisciplinary project team.

This dynamic position works closely with program team members across various functional groups within BlueRock, assures nonclinical development studies (both GLP and non-GLP) are performed according to the study protocol at external CROs, and compiles nonclinical documents for regulatory submissions. An ideal employee will be passionate to contribute to advance programs and to deliver safe cell therapies to patients.

Responsibilities:

  • Lead nonclinical safety within Preclinical Development.
  • A nonclinical development representative of project teams throughout various program stages of the life cycle.
  • Support and advise Research in nonclinical safety evaluation of early-stage programs; identify deficiencies and aid to fill data gaps to advance programs to development.
  • Interact cross-functionally with key stakeholders to advance the program based on the nonclinical development strategy.
  • Work closely with Toxicology Operations on vendor qualification, study set-up, protocol development, study monitoring, data and report review, and maintain timeline and study budget for each study.
  • Ensure GLP compliance and appropriateness of nonclinical model welfare at CROs.
  • Act as a Sponsor Representative on nonclinical studies performed at CROs and maintain active communication line with the CRO.
  • Align study designs and dose setting within Preclinical Development and Project Team.
  • Independently ensures the preparation of technical documents, including position papers, risk assessments, and safety summaries.
  • Compile nonclinical portion of regulatory submission documents (e.g., IND/CTA, regulatory interactions).
  • Interaction with regulatory agencies, as needed.
  • Communicate with clinical team on the clinical development plan, review clinical protocol, compilation of Investigator's Brochure, and provide input to Target Product Profile.
  • Collaborate on externally partnered programs, as necessary.
  • Perform program due diligence, as assigned.
  • Coordinate with consultants, as needed.
  • Provide written and oral presentations internally and externally, as required.
  • Participate in project sub teams or departmental working groups.

Minimum Requirements:

  • PhD or a degree commensurate with experience.
  • American Board of Toxicology (ABT) certification is a plus.
  • A minimum of six (6) years of toxicology experience in pharmaceutical industry.
  • A broad knowledge of research and development process.
  • Experience in cell and/or gene therapy modality is a plus.
  • Familiarity of regulatory guidance (e.g. ICH, FDA, EMA) and experience in GLP studies.
  • A proven track record of successful IND compilation.
  • Exposure to working in a project/program team environment.
  • Excellent oral and written communication.
  • Able to travel (up to 10%).

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