The Director/Senior Director, Toxicology will be responsible for nonclinical safety studies. He/She will be responsible and accountable for the design and execution of all safety studies from discovery to early/late development projects. All interactions with CRO’s will be managed to ensure delivery of study results and reports consistent with project timeline. Additionally, he/she will be accountable for the delivery of proper documents for regulatory filings.
- Oversee nonclinical safety related project activities from discovery stage through regulatory filings and to commercialization.
- Develop and oversee the execution of phase appropriate nonclinical safety strategies along with integrated project plans including milestones, timelines, resources and budgets.
- Provide strategic contribution as the subject matter expert for GLP, non-GLP, and safety pharmacology studies.
- Liaise and represent the company as the nonclinical safety expert before U.S. and European regulatory authorities
- Drives and is accountable for delivery of audited and timely delivery of high-quality safety reports to enable clinical plans and regulatory filing submissions in multiple markets.
- Identify, lead, manage, and build a long-term relationship with CROs for delivery of nonclinical safety studies for pharmaceutical candidates.
- Reviews and provides expertise for all safety associated regulatory and quality documents associated with INDs, NDAs and other regulatory submissions and documentation
- Creates the standard for compliance to meet and exceed regulatory requirements both internally and externally by ensuring CROs are using systems and processes in compliance with all relevant regulatory standards.
- Serve at the toxicology representative as all cross-functional meetings both internally and externally
- Responsible for forecasting and managing nonclinical safety program investment plans that align with business goals
- Proactively manages risk and drives project related decisions to ensure teams are successful in achieving their goals and team milestones.
- PhD in Pharmacology, Biology, Toxicology, or related scientific discipline
- 10+years of experience in a pharmaceutical or biotechnology management of nonclinical safety activities for discovery and development programs
- Experience with gene and/or cellular therapies a plus.
- 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 and managing US and International CROs for protocol design and study execution
- Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.
- Leadership experience with managing teams, budgets and resources to enhance business objectives