Director, Clinical Supply

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

📋 Description

• Oversee the planning and execution of Clinical Supply Chain activities to support worldwide clinical studies.

• Coordinate operations related to clinical packaging, labeling, and distribution.

• Proactively manage inventory, logistics, and forecasting for the clinical program.

• Act as the subject matter expert on clinical drug supply during all stages of clinical trials.

• Assist in the implementation of global clinical inventory management, supply planning, and distribution systems in alignment with cGMP, clinical development programs, and corporate goals.

• Supervise vendor performance and monitor performance metrics.

• Oversee contract manufacturing processes including packaging, labeling, and international shipping/distribution of investigational medicinal products.

• Manage, guide, and mentor Clinical Supply Managers.

• Collaborate with contract manufacturers and finalize business and performance metrics.

• Partner with CMC, Clinical Operations, QA, and Regulatory for kits, label text, and IND filing assistance.

• Develop SOPs, protocols, and procedures for clinical trial material packaging, labeling, and distribution in accordance with cGxP standards.

• Oversee the development of pharmacy manuals.

• Handle vendor selection and collaborate with Regulatory Compliance and QA on CMO selection and qualification.

• Serve as the subject matter expert during regulatory inspections.

• Tackle risk management concerns and implement business continuity strategies.

⛳️ Requirements

• A minimum of 8 years of relevant experience in the pharmaceutical sector.

• At least 5 years of direct experience in Global Clinical Supply Management.

• Prior experience with investigational drug products.

• GCP training is a prerequisite.

• Recent industry experience with clinical supplies or clinical operations is preferred.

• Strong ability to communicate and maintain effective collaborative relationships with key internal and external stakeholders.

• Proven track record in selecting, securing, and managing external vendors to achieve results and control costs.

• Demonstrated experience in global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, and clinical trial designs (randomized, double-blind, placebo-controlled).

• Comprehensive knowledge of cGMP, ICH/cGXP guidelines, and global Health Authority requirements.

• Proficient in software applicable to IVRS/IWRS, Excel, PowerPoint, and MS Project.

• Excellent organizational, communication, and presentation skills, along with effective project and time management skills, and the ability to work under pressure.

• Experience with regulatory submissions is an advantage.

• Capability to use a computer, communicate via phone, video, and electronic messaging, solve problems, collaborate with others, and maintain general availability during standard business hours.

🏝️ Benefits

• Equal employment opportunities and safeguards against discrimination and harassment.

• Remote work environment.