Summary
The primary responsibility of this position is to provide DMPK strategic and technical expertise and representation for discovery and development programs. The successful candidate will report to the VP of Preclinical Research.

Job Description and Primary Responsibilities:
? Responsible for providing DMPK/BA strategy, expertise, representation and resources to all discovery and development teams across all therapeutic areas and stages of development.
? Provide strong management skills and demonstrate ability to manage and lead internal and external resources
? Provide scientific leadership and oversight of the DMPK/BA; working closely with Discovery, Chemistry, Toxicology and Clinical colleagues/CROs
? Serve as DMPK team leader for multiple programs and contribute to the program’s goals and deliverables.
? Highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards.
? Establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for DMPK/BA studies and other activities in support of portfolio programs, and provide submission-ready documentation for the DMPK/BA components of regulatory submissions

Qualifications
? 5+ years industry-related experience in discovery and development DMPK/BA working within the biotechnology, pharmaceutical or CRO industry
? Hands-on experience in all aspects of DMPK study conduct, including: study design, execution, interpretation and reporting, in vitro/in vivo PK & PD and ADME, methods, animal models, inter-species scaling, advanced data analysis, reporting and compliance.
? Extensive experience in the outsourcing and external oversight of DMPK/BA studies conducted by qualified suppliers.
? Experience in analytical and BA methods that are fit for purpose to support discovery and development.
? Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenge, new ideas, information, situations or criticism
? Fluency in written and spoken English is required
? Training in construction of PK model in WinNonLin is a must; PK/PD and PBPK modeling and simulation, and prediction of first-in-human and human equivalent doses is a plus.
Education
? Ph.D. or equivalent in related field.

Employment Category
? Full-Time Regular