Senior Manager, Clinical Supply

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

📋 Description

• Carry out clinical supply chain operations that support Pulmovant clinical studies on a global scale.

• Oversee clinical packaging, labeling, and distribution processes.

• Manage inventory and logistics for the clinical program.

• Act as the subject matter expert on clinical drug supply throughout all phases of clinical trials.

• Assist in the implementation of global clinical inventory management, supply planning, and distribution systems.

• Supervise vendors and evaluate performance metrics.

• Facilitate clinical supply activities for ongoing and new clinical trials, which includes protocol demand forecasting, drafting pharmacy manuals, trial monitoring, initial and resupply planning, and distribution.

• Collaborate with Clinical Operations, CROs, and clinical sites to support recruitment and participant dosing.

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

• Collaborate with CMC, Clinical Operations, QA, and Regulatory to create kits and label text for various countries/regions.

• Lead or contribute to IXRS development and system maintenance.

• Aid in the creation of risk mitigation plans and inspection-readiness processes.

• Support vendor selection and CMO qualification alongside Regulatory Compliance and QA.

• Coordinate global material logistics and movement with the CMC team.

⛳️ Requirements

• A minimum of 5 years of relevant experience in the pharmaceutical industry.

• At least 2 years of direct experience in Global Clinical Supply Management.

• Previous experience with investigational drug products.

• GCP training is mandatory.

• Recent experience in clinical supplies or operations is preferred.

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

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

• Proficiency in software related to IVRS/IWRS, Excel, PowerPoint, and MS Project.

• Strong organizational, communication, and presentation skills.

• Effective project and time management abilities.

• Capability to work under pressure.

• Proficient in using a computer and communicating via phone, video, and electronic messaging.

• Ability to engage in problem-solving, analysis, dialogue, collaboration, and maintain general availability during standard business hours.

🏝️ Benefits

• Remote work environment.

• Equal employment opportunities and protection from discrimination and harassment.