Exel
DMPK Director
Alameda, CA · Director
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About the role
- The base pay range for this position is $166,500 - $236,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
Responsibilities
- Lead the IND- and NDA-enabling ADME work; characterize the ADME of molecules and collaborate to establish in vitro to in vivo correlations; ensure that all DMPK studies and analyses are consistent with regulatory guidance
- Closely partner with Discovery to evolve translational ADME strategies and collaborate on roll-out and execution to ensure deep integration of knowledge from Discovery to Development
- Work collaboratively with other functional partners including Translational Medicine, CMC, Toxicology, Clinical Development and Regulatory to deliver on project and corporate objectives
- Prepare high quality regulatory documents including IND, CTA, and NDA filings; prepare DMPK components of nonclinical and clinical study protocols, nonclinical and clinical study reports, and investigator brochures
- Support functional area reviews for due diligence evaluations
- Maintain external scientific visibility through publications
- Performs other duties as assigned
Requirements
- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
- PhD degree in Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences or other relevant field and a minimum of 8 years of relevant experience in DMPK in the pharmaceutical industry
Skills
- Equivalent combination of education and experience
- Minimum 8 years experience in DMPK
- Expert knowledge of in vitro and in vivo ADME studies
- Experience managing external DMPK work at CROs
- Experience with submission of IND/NDA/BLA and global marketing applicatiions
- Experience with antibody drug conjugates is a plus
- Demonstration of independent thought/creativity in science and drug discovery
- Experience in applying emerging science and technologies to strengthen and improve research capabilities
- In-depth knowledge of current practices and issues in DMPK (including regulatory requirements), PKPD and translational sciences
- Excellent collaborative verbal and written communication skills
Compensation
- The base pay range for this position is $166,500 - $236,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.