Senior Manager of Pharmacokinetics

The Senior Manager of Pharmacokinetics will support the Senior Director of Clinical Pharmacology and Pharmacokinetics to provide analysis and interpretation of all pharmacokinetic and pharmacodynamic data and for the design of human and non-clinical ADME studies.

Responsibilities:

• Serving as the pharmacokinetic point person on both animal and human studies
• Conducting noncompartmental analyses of nonclinical and clinical data
• Plotting and evaluating animal and human pharmacokinetic data
• Performing in vitro in vivo correlations to link in vitro drug data to in vivo performance
• Writing pharmacokinetic and/or toxicokinetic reports
• Reviewing bioanalytical and method validation reports
• Contributing to clinical pharmacology development plans and regulatory submissions, including INDs, IBs and NDAs etc.
• Strictly adhering to agreed timelines to insure prompt and accurate execution of deliverables
• Providing subject matter expertise in cross functional teams and collaborating with other team members
• Contributing to study protocols, analysis plans, bioanalytical reports, and study reports

Preferred Skills, Qualifications and Technical Proficiencies:

• Hands-on and in-depth knowledge of current versions of pharmacokinetic and data analysis software programs such as Excel, Phoenix WinNonlin and GraphPad etc.
• Hands-on and in-depth knowledge of current versions PowerPoint and Word etc.
• Thorough understanding of current regulatory requirements
• Excellent written and oral communication skills
• Proven ability to critically analyze problems and provide creative solutions
• Discipline and confidence to work in teams and to work independently

Preferred Education and Experience:

• 2-5 years of industry experience and a PhD, PharmD or MD degree with emphasis in pharmacokinetics, clinical pharmacology, or a related field

The pay range that the Company reasonably expects to pay for this position is $170,000 - $200,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and other wellness benefits, dependent on the position offered.  

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.