AD / Director, Clinical Pharmacology

Location
San Francisco, CA
Posted
Jun 25, 2022
Ref
5551-341-R
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Assoc. Dir / Director, Clinical Pharmacology will 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. 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.
  • Partner with Research Biology to establish and refine PK-PD-efficacy relationships; collaborate with Toxicology to select appropriate doses and schedules for safety assessments
  • 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)                                                 
  • Develop and maintain collaborative working relationships with colleagues within and outside the department

Qualifications / Experience:

  • At least 13 years’ related experience, 10 years of management 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 preclinical data  
  • 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