Sr. Director, Clinical Sample Management
Nektar is seeking a leader to direct the strategy and execution of operations and management of the clinical sample management (CSM) group. Works with internal and external partners and stakeholders to implement and maintain a compliant end to end process for biospecimen management across all Nektar clinical programs.
- Serve as CSM department head, leading a team of sample managers and associates to implement and maintain processes for efficient and compliant clinical sample management across Nektar’s portfolio
- Responsible for oversight of all clinical sample (biospecimen) management activities across Phase 1 to Phase 3 multinational trials
- Proactively maintain efficient cross-functional interactions between the CSM team and Clinical Operations, Clinical Pharmacology, Clinical Data Management, and other departments
- Serves as a resource to ensure biospecimen collection strategies, documentation, and reporting are compliant ICH and GCP Guidance
- Represent and serve as the subject matter expert during audits and inspections
- Coach and mentor CSM staff
- Serve as a point of escalation to provide guidance to staff and/or directly resolve issues with partners and stakeholders
- Identify and implement systems and tools consistent with current best practices for the pharma industry (domestic and international)
- Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people
- Develop corporate and/or organizational policies and authorizes their implementation
- Interact frequently with senior leaders regarding matters of significance to the organization
- Contribute to the development and implementation of the clinical program strategy and manage those systems and programs in order to meet company goals and objectives
- Identify program and resource gaps with proposed solutions
Minimum Bachelor’s degree is required; PharmD or MS/PhD in a scientific discipline is desirable. A minimum of 12 years relevant pharmaceutical industry experience with at least 10 years experience managing CROs. Clinical sample (biospecimen) management experience in global clinical trials is required, preferably in oncology. A minimum of 8 years people-management experience is preferred. Previous demonstration of developing and leading a sample team required. Experience and understanding of ICH and GCP. Demonstrated ability to solve problems with innovative solutions along with strong organizational and leadership skills. Excellent written and verbal communication skills. Self-starter and team player with strong interpersonal skills. Excellent project and management skills. trong computer skills with a proficiency in Microsoft Project, Word, Excel, and PowerPoint.