Director of Toxicology

Proclinical is seeking a Director of Toxicology for a leading gene therapy company located in Boston, MA. The successful candidate will have overall responsibility for leading all aspects of the toxicology strategies to enable gene therapy drug candidates from discovery through development.

Job Responsibilities:

• Plan and design all nonclinical studies, including non-GLP and GLP studies (safety pharmacology and toxicology studies), primarily through contract research organizations (CROs).
• Manage the budget for non-clinical safety studies.
• Manage contracts and coordinate activities with CROs; Serve as study monitor.
• Prepare study reports and regulatory documents, including investigator's brochures, INDs and NDAs.
• Contribute to and participate in meetings and interactions with regulatory agencies.
• Work closely with other functional areas such as Biology, Medicinal Chemistry, DMPK, CMC and Clinical.
• Provide strategic preclinical expertise to cross-functional project teams as the in-house preclinical expert.

Skills and Requirements:

• Ph.D. in toxicology, pharmacology, physiology, biology, or related discipline
• 10+ years of preclinical safety experience in the pharmaceutical/biotechnology industry experience
• Diplomate, American Board of Toxicology (DABT)
• Demonstrated expertise in nonclinical study design and management with small molecule drug candidates
• Demonstrated track record of successful regulatory filings
• Adequate understanding and experience in PK/TK studies
• Experience in contracting and managing safety studies with reputable CROs
• Experience with pre-IND through Phase 1-3 programs and associated regulatory filings
• Experience in working with U.S. and European regulatory authorities
• Strong critical thinking and analytical skills
• Excellent communication and presentation skills
• Excellent team management skills
• All aspects of adaptation of these assays into clinically acceptable formats with acceptable quality control standards.
• Contribute to the design of innovative early development studies (Phases 1, 1b and 2a) in collaboration with the Program lead, with the aim of making strategic go/no go decisions efficiently and at low cost.
• Oversees design of proof-of-concept studies and full development for various therapeutic area programs.
• Serves as point-person accountable for translational strategy and biomarkers discovery on projects and multi-functional clinical program teams.
• Develops, manages, and implements operating budget for Translational Development, ensuring the financial resources are effectively allocated and managed to support achievement of the strategic objectives.

If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 857-362-9542 or m.robinson@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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