Director, Bioanalytical

Location
San Francisco, CA, United States
Posted
May 27, 2021
Ref
5359-392-NB
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Director, Bioanalytical to join their Bioanalytical Development team.

Seeking a unique candidate with cross-disciplinary knowledge and strong experience encompassing bioanalytical, project management and quality. Works with head of department to lead and organize bioanalytical activities. Will be accountable and responsible for managing contract testing labs that support the analysis of pharmacokinetic and biomarker samples for Nektar clinical studies, which is critical for supporting the expansion of late-stage clinical studies. Will serve as a bridge between our San Francisco and India bioanalytical sites and external contract labs. Will be responsible for coaching and mentoring staff.

Responsibilities
  • Takes a leadership role to organize and plan the activities of the bioanalytical group by working collaboratively with bioanalytical team members and proactively communicating with internal stakeholders to ensure appropriate timing and delivery of data.
  • As an SME for ligand binding assays, must be able to independently and critically assess and review method development and validation plans and reports and bioanalytical data to support clinical studies.
  • Identifies, evaluates, and manages contract labs developing and validating ligand binding assays and analysis of samples supporting non-clinical GLP and clinical studies.
  • Will represent Bioanalytical Development in cross functional study teams to maintain effective communication and provide project status and progress.
  • Able to author and review relevant sections of regulatory filings (INDs, IMPDs, BLAs etc), investigator brochures and clinical study protocols and reports.
Qualifications/Experience:
  • A minimum of a Masters degree in a relevant scientific discipline is required. An advanced degree is highly desired. Equivalent experience may be accepted.
  • A minimum of 13 years of experience in the pharmaceutical or biotechnology industry is required with 10 years of experience leading and building teams.
  • Expertise in pharmaceutical research or development with hands-on experience in relevant laboratory techniques and strong working knowledge of GLP requirements, bioanalytical guidance and relevant white papers.
  • Knowledge of statistical techniques and use of relevant computer software such as GraphPad Prism.
  • Strong verbal and written communication interpersonal skills to develop successful relationships and influence customers.
  • Excellent project management and organization skills to set expectations, negotiate proper milestones and to track progress are required.
  • Ability to work with senior management.
  • Strong computer skills with proficiency in Word, Excel, PowerPoint. Experience with Watson LIMS and electronic notebooks is highly desired.
  • Goal-oriented, quality-conscientious, and customer-focused.
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.