Director, Drug Metabolism and Pharmacokinetics (DMPK)Calithera
Calithera Biosciences is a biopharmaceutical company that focuses on discovery and development of novel small molecule therapeutics in the area of oncology.We are seeking talented scientific staff that embody the entrepreneurial spirit and who thrive in a fast-paced environment. The individual will lead a team conducting in vitro and in vivo drug metabolism, absorption and pharmacokinetic studies to support the discovery and development programs at Calithera. As needed, the candidate will manage external collaborations to provide services that are not available in-house. The candidate would have the qualifications and experience as listed below.
Direct the activities of the DMPK group and external collaborators (CROs) to achieve company goals and maintain critical timelines.
Develop and/or oversee the development of in vitro and in vivo ADME assays and bioanalytical methods to support lead optimization and preclinical/clinical development.
Utilize DMPK knowledge to design robust and discriminating metabolism assays and bioanalytical methods to facilitate compound triage and project decision making.
Critically analyze data, provided data summaries for project team and senior management team, and recommend strategic and/or tactical adjustments based on the data when warranted.
Take the lead role in authoring the PK/DMPK portion of internal reports and regulatory documents as well as stand-alone technical reports
Effectively communicate in oral and/or in written form to internal or external audiences.
Participate on senior leadership teams to set company strategy and priorities.
Manage direct reports effectively as required.
Maintain equipment in good working order and make recommendations for repair or replacement.
Responsible for developing and maintaining departmental budget for capital expenditures, consultants, hiring, CROs, and supplies.
PhD degree in Pharmaceutical Science, Chemistry, Pharmacology, Pharmacokinetics, or other related disciple, plus 10+ years of experience in Pharmaceutical R&D or equivalent industry experience or training
Exceptional understanding of multiple DMPK areas evidenced by a strong record demonstrating comprehensive knowledge of experimental DMPK methodologies and approaches, in vitro and in vivo
Strong track record of supporting metabolism, PK and PK/PD on projects both in-house and with CROs, with a focus on delivery of results and meeting timelines
Good understanding and experience of GLP bioanalytical methodology and expertise in analysis tools such as WinNonlin
Strong leadership experience, excellent organization and written and oral communication skills
Goal-oriented in a fast-paced environment