Director, Pre-Clinical Development
Lead BioDelivery Sciences’ preclinical program on its pipeline product. The position reports to the SVP and Chief Technology Officer. The position will provide scientific leadership and play a pivotal role in developing the nonclinical strategy. He/she will design, implement, interpret and report data from nonclinical and toxicology, toxicokinetic, histopathology studies for its pipeline products.
The individual will engage with the CMC and regulatory team for formulation selection and conduct critical GLP studies for a successful IND submission. The individual will be an accomplished nonclinical development scientist with a proven track record of significant contributions to project goals and problem solving. Serves as a toxicology subject matter expert providing project support including developing program nonclinical strategies and reporting key program nonclinical milestones and timelines to project teams.
Work with cross-functional partners to establish project success criteria, monitor project progress, and communicate information to management. Function as study monitor for preclinical studies at contract laboratories by designing, monitoring and overseeing reporting of studies conducted by CROs. Summarize, analyze and interpret study results and communicate information to project teams and management.
The core responsibilities of this position include development and execution of nonclinical drug development strategies, as well as design and oversight of outsourced nonclinical studies (toxicology, safety pharmacology, and DMPK assessments) conducted at a Contract Research Organizations (CROs).
The candidate must have direct experience designing, managing and reporting results from toxicology and other safety studies, managing external CROs, and drafting nonclinical sections for regulatory submission. This individual must work collaboratively with internal and external cross-functional teams, collaborators, CROs and consultants to map complete development pathways for each drug candidate.
Requirements - A PhD or equivalent in toxicology. Minimum of 10 years of experience in a pharmaceutical industry including at least 7 years of experience in managing scientists. Worked in a R&D organization including Quality, Compliance, Manufacturing, Product Development, and Regulatory Affairs. Deep understanding of in vitro and in vivo pharmacology models. Understanding of critical issues in drug discovery and development. Working knowledge of FDA guidelines for therapeutics development. Demonstrated ability to prioritize and clearly articulate research objectives. An innovative attitude coupled with a strong sense of practical execution. Strong record of mentoring and enabling career development. Must have the ability to work collaboratively as part of a team in a fast-paced dynamic environment. Excellent interpersonal skills with the ability to inspire subordinates, peers, and superiors. Ability to travel (10%).