at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Discovery Biology group is looking for an Exec. Dir./Associate VP, Drug Metabolism & Nonclinical Pharmacokinetics. The ED/AVP, Drug Metabolism and Non-Clinical Pharmacokinetics, is responsible for all aspects of non-clinical pharmacokinetics/toxicokinetics, biotransformation and bioanalysis from preclinical programs through drug approvals. The role includes providing non-clinical DMPK scientific expertise, guidance and leadership for small molecule and biotherapeutic programs, supporting both non-GLP and GLP studies. This highly visible role requires exceptional communication skills with senior stakeholders and an ability to work effectively with the medicinal chemistry, pharmacology teams, and safety assessment functions.
Essential Functions of the Job:
Provide non-clinical pharmacokinetic and toxicokinetic leadership to research programs from lead optimization to drug approvals for small and large molecules; identify liabilities and provide risk assessment.
Responsible for bioanalytical teams; ensure successful and fully compliant operation of regulated activities including GLP laboratory activities.
Provide guidance to biotransformation of small molecules from discovery through development including 14C studies and MIST regulations.
Provide leadership and perspective regarding DDIs for discovery candidates through clinical protocols.
Provide leadership and guidance for all non-clinical DMPK regulatory submittals, IB updates and queries from regulatory agencies.
Foster and drive a culture of high quality experimental design, timely data generation and analysis to support decision making for individual research programs.
Drive productive and collegial partnerships across medicinal chemistry, discovery biology teams, quality assurance and regulatory.
Effectively communicate functional area updates/issues to stakeholders internally and externally.
Champion application of new technologies and platforms as needed
Recruit, develop and retain highly skilled scientists with a proven record of accomplishment of enabling cutting edge drug discovery and development.
Be responsible for prudent management of the departmental budgets.
Manage resourcing of multiple projects to ensure achievement of department, company and strategic objectives.
Be an effective sounding board for diverse ideas and champion adoption of value adding strategic initiatives.
Ph.D. in the life sciences with DMPK training and at least 15 years industry experience with 10 + years of leadership experience in a successful and productive environment and across various stages of pharmaceutical R&D
Hands-on experience in pharmacokinetics and understanding of biotransformation with broad understanding of state of the art bioanalytical methods, technologies and data interpretation.
Deep understanding of the drug discovery process and regulatory guidelines with experience advancing discovery candidates to IND/NDA.
Extensive experience in managing, mentoring and developing talent across multidisciplinary teams
We appreciate, celebrate, and thrive on one another’s differences and strengths and are proud to be an Equal Opportunity Employer. By valuing diversity of backgrounds and perspectives and prohibiting all forms of harassment, we are able to promote a collaborative and innovative work environment in which everybody can contribute to their fullest potential.