The Associate Director leads the planning, execution, and oversight of clinical supply operations to ensure that investigational products, packaging, labeling, and related materials are available on time, in compliance with protocols, and meet regulatory requirements
Key Responsibilities
- Supply Chain Leadership: Provide strategic leadership for clinical supply chain activities, including demand planning, forecasting, procurement, packaging, labeling, distribution, and return of clinical supplies
- Collaboration: Work closely with Clinical Operations, CMC (Chemistry, Manufacturing, and Controls), QA, RA, and cross-functional study teams to align supply activities with study timelines and objectives
- Vendor Management: Serve as primary vendor contact for packaging, distribution, storage, and central pharmacy vendors; manage relationships with CROs, depots, IRT vendors, and ancillary procurement partners Responsible for the oversight of Clinical Supply CMOs.
- Compliance & Documentation: Ensure all supply activities are documented in the Trial Master File; address temperature excursions and expiry extension. Responsible for the creation, periodic review, and maintenance of all Clinical Supply SOPs.
- Quality Assurance: In quality-focused roles, ensure reliable availability, quality, and regulatory compliance of clinical supplies; lead investigations of deviations and quality events. May be called on to serve as the primary representative/subject matter expert (SME) during all inspections and clinical supply chain audits.
- Process Improvement: Drive best practices in supply readiness, inventory control, and distribution; develop KPIs and metrics to measure performance; provide clinical supply and risk mitigation recommendations.
- Program Support: Assist in resource planning for programs and studies.
Required Skills & Experience
- Bachelor''s degree in a scientific discipline, healthcare, or related field. Advanced degree preferred. Equivalent experience may be considered.
- 10 years of experience in the pharmaceutical or other related regulated industry. Thorough understanding of FDA and cGMPs. with 8+ years of global clinical supply chain experience within the biotechnology sector and 5 years previous management. APICS certification is advantageous.
- Strong background in clinical supply chain operations, ideally in biopharma or medical device manufacturing.
- Experience with regulatory compliance (FDA, ICH, GxP) and quality systems.
- Proficiency in forecasting, procurement, and vendor management.
- Ability to work with cross-functional teams and high-visibility projects.
- Familiarity with clinical trial logistics, including IRT (Interactive Response Technology) supply management.
- Strong analytical, problem-solving, and communication skills.
ADDITIONAL INFORMATION
Nektar currently anticipates the base salary for the Associate Director, Clinical Pharmacology to range from $185,000 to $220,000 for candidates in the Bay Area and will depend, in part, on successful candidate location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan, depending in part on company and individual performance and at the Company's discretion. The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
- Health Insurance (Medical/Dental/Vision)
- Disability Insurance
- Holiday Pay
- Paid Time Off (PTO)
- 401(k) Match
- Employee Stock Purchase Plan
- Wellness Programs
- Parental Leave Benefits (in accordance with the terms of applicable plans)
For general information on company benefits, please go to https://www.nektar.com/careers.