Manager, Biosample Management
Nektar has an exciting opportunity for a Manager, Biosample Management to join their Bioanalytical Development team.
The Manager, Biosample Management will be the point of contact and functional lead for all operational activities relating to vendor and sample management in order to deliver quality samples used in evaluating the drug efficacy and pharmacokinetics. This role is an integral part of the study team during study startup, live phase and closeout. Ensures compliance with regulatory agency documentation and reporting requirements. Develops procedures and plans. May participate in vendor negotiations, product and software evaluations, implementations and management. May support both clinical, preclinical and discovery samples. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
- Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinates(s) to meet schedules and/or resolve technical problems. Develops and administers schedules, performance requirements; may have budget responsibilities.
- Works with Outsourcing or Procurement in order to execute lab contracts.
- Reviews and finalizes the lab SOW and ensures all stakeholders are involved for the review. • Identifies stakeholders for questions impacting analysis and custody of samples and escalates issues to internal and external parties to ensure a timely resolution.
- Addresses questions from the CRO, repository or clinical site on sample collections.
- May assist in vendor selection.
- May assist in helping to manage testing vendors.
- Coordinates with business partners and stakeholders in determining samples flow.
- Mentors junior team members.
- Maintains professional demeanor when interacting with internal and external business partners. • Conducts laboratory trainings to appropriate team members, and other internal and external stakeholders.
- Within Clinical Development ensures completion and accuracy of the Clinical Sample Management Plan.
- Utilizes tracking systems in order to report progress, address issues and resolutions.
- Oversees studies of moderate to high complexity.
- Leads meetings which ensures needs of the samples are correct.
- Identifies resources to help conduct the study within Biosample Management.
- Possesses solid communications skills in order to efficiently and succinctly update the stakeholders on progress, questions and issues.
- Identifies, escalates and resolves complex issues.
- Works effectively in a dynamic operational environment with cross functional stakeholders.
- Other duties as assigned.
Bachelor's or equivalent experience required; an advanced degree a plus. 8+ years of related experience with at least 2 years managing CROs daily management of a central laboratory required. Previous clinical biosample management experience is required, preferably in oncology. A minimum of 5 years of supervisory or management experience is preferred. Previous demonstration of developing and leading a biosample team required. Experience and understanding of ICH and GXP is required. Familiar with processes and restrictions of vendors. Demonstrated ability to solve problems. Strong written and verbal communication skills are required. Must be a self-starter and team player with strong interpersonal skills. Must possess effective project management skills.
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.