Director of Toxicology

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%).