Director/Sr. Director, Toxicology

Director/Sr. Director, Toxicology

Location: Remote within the USA- East Coast Preferred

This is a permanent role with a growing gene therapy organization, seeking a pharma industry professional with strong Toxicology and Lipid Nanoparticle (LNP) experience.

Position Overview:

The Director, Toxicology will be responsible for the nonclinical safety assessments supporting Company's development programs. The right candidate will be responsible and accountable for the design and execution of all safety studies, including off-target risk assessment and de-risking for discovery to early/late development programs. Candidate may also support platform workstreams. In collaboration with NCD Ops, will coordinate interactions with CRO's to ensure delivery of study results and reports consistent with program timeline. Additionally, will be accountable for the delivery of proper documents for regulatory filings.

Responsibilities:

• Oversee nonclinical safety related activities from discovery through regulatory filings and to commercialization for both our ex-vivo and in-vivo development programs.
• Develop and oversee the execution of phase appropriate nonclinical safety strategies along with integrated project plans including milestones, timelines, and budgets.
• Provide strategic contribution as the subject matter expert for GLP, non-GLP safety assessments, off-target risk assessment, and safety pharmacology studies supporting development and platform programs.
• Provide toxicology support for regulatory submissions and interactions with health authorities, including the authoring of nonclinical safety sections of US and international regulatory applications and help resolve nonclinical safety queries.
• Drive and be accountable for delivery of high-quality safety reports to ensure clinical plans and regulatory filing submissions in multiple markets.
• Serve at the toxicology and/or nonclinical representative in cross-functional meetings both internally and externally.

Qualifications:

• PhD with 10+ years of scientific experience OR Master's degree with 13+ years of scientific experience. Candidates with DVM highly preferred.
• Bachelor's degree with 15 + years of scientific experience in preclinical toxicology will also be considered.
• 3+ years of experience with LNP, gene and/or cellular therapies highly preferred.
• Ability to develop and deliver clear and concise presentations for both internal and external meetings.
• In-depth understanding of all aspects of nonclinical safety and experience with regulatory filings.
• Extensive knowledge of relevant FDA and EMEA regulations and processes.
• Demonstrated proven experience in working with CROs for protocol design and study execution.
• Ability to operate effectively within an innovative and science-driven company environment; delivery-oriented, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.