Associate Director, DMPK/Bioanalysis

3 weeks ago


San Diego, United States Medix Full time

Position Description: The Associate Director, PK and Bioanalysis will play a pivotal role in directing the scientific aspects and processes of in vivo pharmacokinetic studies. This leadership position involves providing scientific direction to our technical staff, implementing efficient processes, expanding capabilities, and ensuring high-quality standards for study design and reporting.

Primary responsibilities: Direct and oversee the science and processes involved in the execution of in vivo pharmacokinetic studies. Provide scientific direction, oversight, and guidance to the technical staff, ensuring the highest standards of study design and execution. Expand PK and bioanalytical capabilities to enhance existing services and serve the evolving needs of the industry. Act as the technical representative in supporting sales interactions with new and prospective clients, contributing to the growth of PK and Bioanalysis studies. Collaborate with Business Development and scientific leadership of DMPK to identify, pursue, and close new opportunities. Strengthen and expand PK and bioanalytical capabilities. Ensure that departmental policies, practices, and procedures adhere to regulations governing the conduct of preclinical studies. Establish policies and practices to guarantee compliance with all applicable regulations and corporate policies. Oversee the development and communication of departmental systems, SOPs, policies, and procedures. Provide senior-level review of protocols, reports, and related documents, ensuring appropriate scientific content and interpretation.

Qualifications: PhD in pharmacokinetics, chemistry, biochemistry, or a related scientific discipline. Additional experience may be considered in lieu of a PhD. Minimum of 3 years relevant laboratory experience in a contract research organization (CRO), biotechnology, or pharmaceutical environment. Past management experience, including staff management and development, and financial responsibility. Expertise in Bioanalysis and in the design, conduct, and interpretation of in vivo PK studies is required. Experience with noncompartmental analysis (Phoenix WinNonlin) is required. Strong communication skills, attention to detail, and the ability to adapt in a dynamic team environment are essential for success.

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