Scientist II, Clinical Pharmacology

Location
San Francisco, CA, United States
Posted
Nov 04, 2020
Ref
5214-341-R
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Scientist II, Clinical Pharmacology to join their Clinical Pharmacology & Quantitative Sciences Team.

This position will assist in developing and applying clinical pharmacology and translational medicine strategies for candidate drug products from first in human through late stage development (Phase 3 and NDA/BLA filings) using pharmacokinetic, pharmacodynamic, DMPK, and drug therapeutic principles, and knowledge of drug development processes and regulatory guidance. This position contributes to and supports the company's research and development efforts to create new pathways to smarter medicineā„¢.
  • Represent clinical pharmacology on cross-functional project teams involved in the clinical development of candidate drug products.
  • Collaborate with biostatisticians, clinicians and clinical operation managers for the optimal design of Phase I-IV studies; contribute to the clinical study protocols and reports.
  • Work closely with sample management and bioanalytical for the proper collection, processing, and testing of pharmacokinetic and biomarker samples.
  • Assist in integrating and interpreting nonclinical and clinical pharmacology, DMPK, and translational medicine knowledge; in the preparation of clinical pharmacology write-ups and regulatory documents (IND, IMPD, IB, NDA CTD, etc).
  • Create and manage of datasets and perform data analysis such as non-compartmental and compartmental PK/PD analysis.
  • Collaborate with pharmacometricians in the modeling of emerging PK and PK/PD data.
  • Participate in writing publications and making scientific presentations consistent with development strategies.
  • Maintain knowledge of relevant scientific and regulatory practices and trends, and ensure that clinical pharmacology aspects of development programs are contemporary. Other duties as assigned.
A Pharm. D. or PhD in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 4 years work experience in an industry research and/or development environment is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought. Must be able to clearly communicate scientific and technical information both written and oral. Must be able to demonstrate sound judgment and problem-solving capabilities. Strong organizational skills are required. Experience working in an FDA regulated environment and experience and understanding of ICH, and GCP is highly desired. Must have hands-on experience with data analysis, non-compartmental and compartmental PK/PD analysis and using data processing software such as Phoenix WinNonlin, R, NONMEM, and/or MONOLIX. Good working knowledge of graphing software such as SigmaPlot, Prism, JMP, or R is required.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.