Manager, Clinical Supply Chain

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the formulation and implementation of clinical supply strategies for early to mid-phase clinical trials (Phase 1–3 as applicable).

• Oversee clinical supply plans, demand forecasts, and inventory strategies, including monitoring via Interactive Response Technology (IRT) systems.

• Aid in the packaging, labeling, distribution, and resupply activities for investigational products and comparators.

• Ensure timely delivery of clinical supplies to depots and clinical sites worldwide.

• Collaborate with Quality, Clinical, CMC, and external CDMOs to create, review, and approve clinical labels.

• Assist in managing CDMO packaging/labeling timelines to guarantee supply availability.

• Administer logistics and licenses needed for shipping materials from manufacturing to bulk storage facilities, courier depots, and investigator sites.

• Work alongside CMC and QA to facilitate the documentation transfer necessary for IP/QP release by CDMOs.

• Track shelf-life and expiry dates, and coordinate retest/extension activities.

• Handle investigations and communicate issues related to temperature excursions and product complaints.

• Support product recovery efforts pending the investigation of IP from investigator sites.

• Communicate across various functional areas regarding clinical supply chain processes.

• Draft Pharmacy Manuals for clinical studies as required.

• Represent Supply Chain in Clinical and CMC Sub-Team meetings.

• Report directly to the Senior Director, Clinical Supply Chain.

⛳️ Requirements

• A Bachelor’s degree in engineering or science is required.

• 3–5 years of experience in the biotech/pharma industry focusing on clinical supply chain, including international experience, is required.

• Proficient understanding of clinical supply chain processes and GMP/GDP requirements.

• Experience in coordinating cross-functional project teams and managing external vendors.

• Strong organizational, analytical, decision-making, and interpersonal abilities, with a keen eye for detail.

• Capability to work independently in a fast-paced, dynamic environment.

• Proven ability to coordinate CDMO activities supporting the clinical development of pharmaceutical products.

• Ability to excel in a small-company culture and contribute to the development and implementation of processes.

🏝️ Benefits

• Company bonus based, in part, on both company and individual performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug benefits.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including employee assistance programs, fitness benefits, and employee clubs and activities.

• Employee resource groups (ERGs) providing support networks.