Associate Director, Clinical Biosample Management

San Francisco, CA, United States
Apr 12, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Will be responsible for developing standardized systems and approaches for tracking clinical biosamples, managing central laboratories and bioanalytical vendors on a day to day operations level.

This includes contributing to the strategic and operational leadership relative to the direction, planning and execution of clinical programs and the data collection activities. Works with senior Clinical Operations management to implement clinical protocols and data collection systems. Monitors clinical sites, central and bioanalytical laboratory adherence to protocols. Interacts with various inside/outside groups to facilitate clinical programs.

Ensures budgets, schedules and performance requirements are met. Contributes to the development, management, and execution of the Clinical Development Plan (CDP) which includes timelines, budget, and resource requirements. Contributes to the development and implementation of the clinical program strategy and manages those systems and programs in order to meet Company goals and objectives. Identifies program/resource gaps and proposes solutions. Provides weekly central and bioanalytical laboratory updates to senior manager. Proposes innovative ideas to help resolve challenges faced by the project team. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs.

A Bachelors/Masters degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 10 years Pharmaceutical development experience, at least 4 years managing CROs and daily management of a central laboratory is required. A minimum of 8 years previous management experience is may be required. Oncology and clinical biosample management experience is highly desired. Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint.

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.