Executive Director, Pharmacokinetics
Company: Nektar Therapeutics
Location: San Francisco
Posted on: November 22, 2021
The Executive Director, Pharmacokinetics directs the strategy
and execution of ADME/PK activities from early discovery to
first-in-human trials. Reporting to SVP of Clinical & Nonclinical
PK-PD, this role will work closely with Research Biology and
leverage expertise in PK-PD and experience in DMPK to innovate
novel biologic and small molecule drug products. Collaborates with
early development to design fit-for-purpose studies for regulatory
submissions. Manages and mentors a staff of subject matter experts
in DMPK, bioanalytics, and vivarium management.
- Leads project teams from early discovery through clinical
development to identify critical ADME/DMPK needs and formulate
strategies to address those issues.
- Integrates in vitro and in vivo ADME results to establish best
assays to understand and optimize compound properties in a
- Delivers data on aggressive timelines to guide medicinal
chemistry efforts in optimizing PK.
- Partners with Research Biology, Quantitative Sciences, and
Clinical Pharmacology to establish and refine PK-PD-efficacy
- Collaborates with Toxicology to select appropriate doses and
schedules for safety assessments.
- Manages and mentors a staff of DMPK scientists, DMPK
bioanalysts, and vivarium specialists.
- Provides detailed supervision of CROs in the execution and
design of both standard and novel experiments to understand PK-PD
and PK issues.
- Writes and reviews regulatory documents to enable IND and
BLA/NDA approvals. PhD or equivalent in drug metabolism or related
field with 15+ years of direct industry experience. Direct
experience in discovering and developing drug products (both
biologics and small molecules). Team leadership experience with 5+
years as a people manager. Proven ability to drive drug discovery
projects from early development through clinical development.
Advanced knowledge of bioanalytics, mechanistic in vitro and in
vivo experiments to determine the cause of PK issues, and scaling
of preclinical DMPK data to predict human PK and dosing schedules.
Familiarity with current FDA and EMA guidelines. Ability to
collaborate across disciplines. Strong organizational skills,
superior communication skills (both written and oral). Demonstrated
experience in developing and successfully managing budgets and
contracts. Ability to work well under pressure and drive projects
that affect critical timelines. Performance of tasks essential to
the job function may require the employee to work directly with,
handle, or otherwise come into contact with chemicals or
pharmaceutical agents. Employees may be required to enroll in a
medical surveillance program based on the potential exposure to
certain health hazards encountered as a result of their job
Keywords: Nektar Therapeutics, San Francisco , Executive Director, Pharmacokinetics, Executive , San Francisco, California
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