The Director, Toxicology interacts with research and development teams to design critical pathways for nominating compounds as development candidates, designs and conducts safety evaluation of development candidates to support clinical trials and registration and prepares nonclinical sections of regulatory submissions. The successful candidate will also participate in advancing programs acquired through business development activities. The successful candidate will serve as a senior member of the department and will serve on project teams. This position reports to the Vice President, Toxicology.
Essential Duties and Responsibilities:
- Serves on project teams in research and development
- Collaborates with Research to develop critical pathways to select development candidates
- Designs and executes studies for regulatory submissions that support clinical trials and product registration
- Interacts with regulatory agencies on toxicity issues related to their projects
- Provides guidance to the Nonclinical Study Management team to ensure that nonclinical studies are conducted with attention to quality and timelines
- Maintains awareness of current and emerging standard practices and guidelines
- Academic training in toxicology, pathology or related discipline, preferably with advanced degree (Ph.D., D.V.M.) and board certification (DACVP, DABT)
- 12+ years of relevant experience in toxicology with a minimum of 7 years in pharmaceutical drug development
- Ability to work with interdisciplinary teams
- Excellent verbal and written language skills
- Excellent organizational and time management skills
- Experience with managing studies conducted at CROs
Fit with GBT culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.