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Associate Director, Clinical Pharmacology

Employer
Nektar Therapeutics
Location
San Francisco, CA
Start date
Sep 3, 2021

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Discipline
Clinical, Clinical Research, Science/R&D, Pharmacology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay

Job Details

We are recruiting a highly motivated Associate Director, Clinical Pharmacology to drive clinical pharmacology and pharmacokinetics activities in support of early and late stage clinical programs.  To support the advancement of Nektar’s clinical pipeline, the successful candidate will represent the function on clinical study teams.  The candidate will work closely with experts in clinical operations, statistics, quantitative scientists, quality assurance, and other development functions to develop and execute clinical protocols. The candidate will be responsible for coaching and mentoring junior staff.  Our group emphasizes a collegial, collaborative environment and has a strong record of scientific innovation. 

Essential duties and responsibilities:

  • Provide clinical pharmacology expertise and oversight during clinical study execution
  • Perform noncompartmental PK and PD analyses of clinical trial data and collaborate with Data Management to ensure compliance with CDISC standards
  • Contribute to clinical trial related documents (protocols and amendments, informed consent forms, site training materials, statistical analysis plans, clinical study reports)
  • Maintain a close working relationship with bioanalytical development to ensure that the PK assays satisfy programmatic needs and data delivery meets study timelines
  • Collaborate with senior staff to develop strategies and direct efforts in clinical pharmacology to meet regulatory requirements
  • Implement clinical pharmacology tools and technologies to drive efficient drug development
  • Partner with Quantitative Scientists to apply state-of-the art population PK, PK/PD, PBPK, and QSP modeling concepts to inform clinical trials and for regulatory submissions.
  • Organize and interpret data, and present analyses to key internal (development teams, senior management) and external stakeholders (advisory boards, scientific meeting abstracts, posters, and manuscripts)                                                 
  • Supervise, develop, and mentor junior level scientists
  • Develop and maintain collaborative working relationships with colleagues within and outside the department

Qualifications / Experience:

  • At least 10 years’ related experience and an MD, PharmD, or PhD degree with emphasis on clinical pharmacology, pharmacokinetics, or a related scientific discipline 
  • Demonstrated ability to critically analyze problems and provide innovative solutions
  • Thorough knowledge of current and emerging scientific standards and regulatory requirements for global territories
  • Experience in the design, coordination, and implementation of clinical studies
  • Hands-on experience with noncompartmental PK analysis of clinical trial data and familiarity with CDISC standards  
  • Knowledge of contemporary PK, population PK, QSP modeling concepts, data analysis, and interpretation; hands-on experience with applying these concepts to support clinical trials; desire and curiosity to acquire scientific knowledge for portfolio projects
  • Familiarity with GxPs  
  • Previous experience in biologics and knowledge of human immune system and lymphocyte functions for development of immuno-oncology drugs
  • Flexible, results-oriented, and demonstrated ability to work in a fast-paced, timeline-driven environment
  • Excellent written and verbal communication skills and ability to convey complex technical information clearly
  • Strong computer skills with a proficiency in Word, Excel, PowerPoint, WinNonlin

 

 

Company

Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.

Stock Symbol: NKTR

Stock Exchange: NASDAQ

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Company info
Website
Phone
415-482-5300
Location
455 Mission Bay Blvd South
San Francisco
California
94158
United States

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