Senior Director, Toxicology
Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Director, Toxicology.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Serves as the Development Sciences and Toxicology Lead on a wide array of discovery and development teams.
- Guides characterization of safety properties of novel biologics to support decision making and the advancement of preclinical programs and clinical drug candidates.
- Oversees the design and conduct of exploratory, non-GLP, and GLP toxicology studies.
- Interprets and reports results in the context of mechanisms of action or toxicity, dose- and exposure-response relationships, and the impact to predicted safety margins or therapeutic indices for putative drug candidates.
- Develops and conducts related in vitro and in vivo studies in collaboration with other team members and external contributors at contract research organizations.
- Interprets, summarizes, and presents data to internal project teams, senior management, and external partners and organizations.
- A PhD in toxicology or a related field is required.
- Must have 10+ years of biotech or pharmaceutical drug discovery and development experience.
- A Diplomate, American Board of Toxicology (or equivalent) is preferred. Title will be commensurate with experience.
- Requires regulatory experience supporting IND and CTA filings.
- Experience in oncology drug development is highly preferred.
- Experience leading toxicology strategy for late-stage programs is a plus.
- Must have expertise in developing a toxicology strategy that is aligned with regulatory guidance, and in conducting toxicology studies for biologics programs.
- Small molecule and ADC experience is preferred.
- Must have excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and clearly communicate complex toxicology study results and their impact to program and regulatory strategies.
- The ability to be detail-oriented while also retaining the ability to see the big picture is required.
- Must have excellent problem-solving and decision making skills.
- Requires the proven ability to effectively communicate and collaborate with internal team members and external collaborators.
- Must be an excellent team player and have an enthusiasm for science as well as helping discover and develop therapies for unfulfilled medical needs.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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