VP, Preclinical Development
Represents the Company in a wide range of interactions both internally and externally in all aspects of clinical and nonclinical bioanalysis, drug metabolism and pharmacokinetics, and nonclinical toxicology. Will be responsible for all aspects of preclinical development in order to advance drug candidates from discovery to the clinic. Will play a critical role in developing and advancing corporate initiatives and strategic direction. Participates in key decisions impacting the future of drug candidates and the company. Manage and lead all aspects of clinical and nonclinical Drug Metabolism and Pharmacokinetics (“DMPK”) and nonclinical toxicology, incorporating emerging technologies and relevant applications. Significantly contribute to and lead the selection of compounds in Drug Discovery process. Use creative and proactive problem solving to design IND enabling toxicology studies, development and reproductive toxicology studies, chronic toxicology studies, carcinogenicity and genotoxicity testing of drugs to aggressive timelines. Prepare related DMPK and toxicology studies for regulatory filings (e.g., IND and NDA). Propose activities for cross-functional technology relevant to project objectives. Act as an effective technical and strategic leader for the DMPK and nonclinical toxicology groups as well as project teams and others in areas outside of day-to-day responsibilities. In particular, build strong working relationships with drug substance and drug product groups. Assesses cross-functional goals, and realistically plans and executes relevant to functional deliverables.
PhD in Pharmacology/Toxicology or a related discipline, with 15 years of relevant experience in drug discovery and development. Additional relevant experience may serve as a substitute for an advanced degree. Strong practical knowledge of IND, NDA, GLP and GMP requirements. Excellent project, time management, and problem solving skills.
Proven leadership and interpersonal skills, including ability to gain credibility across functional lines. Must be able to select and manage third-party vendors and collaborators. Ability to communicate technical information, and work with all levels and areas within the Company. Excellent written and verbal communication skills are required. Ability to critically evaluate, summarize, interpret and effectively communicate data is required. Ability to make effective and compelling presentations in both large and small groups is required. Ability to communicate complex scientific and nonscientific issues to teams, executives and regulators is required. Ability to understand published scientific literature outside of one’s immediate area of expertise and appropriately apply this understanding is required. Ability to prepare manuscripts and other documents for publication and/or regulatory submission is required.