Senior Manager, Clinical Supplies Planning & Logistics
Location: U.S. (Remote or Hybrid Options Available)

A clinical-stage biotechnology company is seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning & Logistics to join its Clinical Development Operations team. The company is advancing a pipeline of differentiated, orally available small molecule therapies aimed at life threatening chronic diseases with high unmet need. 

This role will lead the end-to-end planning and execution of investigational product (IP) supply across multiple global clinical trials. Responsibilities include supply forecasting, packaging, labeling, and distribution oversight via third-party vendors, as well as strategic input into late-phase development planning. The Senior Manager will collaborate cross-functionally and play a key role in aligning supply logistics with clinical operations and regulatory strategy.

Key Responsibilities

• Lead clinical supply planning and logistics in alignment with study plans, timelines, budgets, and overall development strategy.

• Manage vendor performance, including selection, RFPs, budget negotiations, and operational oversight (CMOs, depots, CROs, IRT, shipping, etc.).

• Collaborate with Clinical Operations and Regulatory teams to develop compliant packaging and labeling strategies and designs.

• Partner with Quality Assurance to ensure IP documentation and processes comply with SOPs, lot tracking, expiry management, and release timelines.

• Oversee all clinical supply activities including demand forecasting, IRT implementation, randomization input, packaging/labeling operations, distribution, temperature excursions, returns, and destruction.

• Contribute to the design and review of study-specific IP documentation, including pharmacy manuals, protocol sections, SOPs, and training materials.

• Ensure accurate and complete documentation for Trial Master File (TMF) and regulatory inspection readiness.

• Provide strategic input for global supply planning, particularly for late-stage, multi-regional trials.

Qualifications

• BA/BS degree required; scientific discipline preferred.

• 10+ years of industry experience, with at least 6 years in clinical supply management.

• Strong experience in global clinical supply planning and logistics for small molecule (tablet/capsule) programs.

• Proven experience supporting large, blinded, global trials, including those involving APAC logistics and import/export.

• Solid understanding of global regulatory requirements: cGMP, GCP, GDP.

• Hands-on experience with IRT/RTSM systems and managing clinical supply vendors.

• Expertise in forecasting, labeling, distribution, and supply chain strategy.

• Familiarity with import/export policies and temperature excursion management.

Core Competencies

• Highly organized, action-oriented, and capable of handling shifting priorities.

• Strong cross-functional leadership and vendor management skills.

• Excellent problem-solving ability and strategic agility.

• Comfortable working with partially remote and global teams (U.S. and Asia).

• High integrity, flexibility, and resilience in dynamic environments.

Travel Requirement

• Up to 20% domestic and international travel may be required.