Pulmovant · 1 month ago
Associate Director, Clinical Supply, Pulmovant
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
7+ years expPulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. The Associate Director of Clinical Supply will lead the planning and execution of Clinical Supply Chain activities to support global clinical studies, managing logistics, inventory, and vendor relationships to ensure compliance with regulatory standards.
Clinical TrialsHealth CareHealth DiagnosticsMedical
Responsibilities
Directly oversee contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials
Manage, coach and mentor Clinical Supply Managers. Develop best in class clinical supply area
Act as primary liaison with contractor(s) (CMO's). Complete business and performance metrics. Negotiate quotes and work orders for new trials
Work with CMC, Clinical Operations, QA and Regulatory to develop kits and label text for multiple countries/regions and provide support for IND filings as required
Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling and distribution to ensure compliance with cGxP requirements
Manage development of pharmacy manuals with appropriate internal subject matter experts
Manage vendor selection for clinical study support, including Clinical Packaging and Labeling facilities as required. Work with Regulatory Compliance and QA in selection/qualification of CMO's
Subject matter expert for clinical trial supply during regulatory inspections
Proactively address risk management issues and implement business continuity plans
Prepare clinical study supply forecasts as required
Qualification
Required
Minimum of 7 years of related experience in the pharmaceutical industry with at least 5 years of direct experience in Global Clinical Supply Management
Prior investigational drug product experience and prior GCP training is required
Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders
Proven ability to select, secure and manage external vendors to achieve results and control expenditures
Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, clinical trial designs (randomized, double, blind, placebo controlled)
Thorough knowledge and understanding of cGMP, ICH/cGXP guidelines and global Health Authority requirements
Proficiency in computer software applicable to IVRS/IWRS, Excel, Power point and MS Project
Good organizational, communication and presentation skills, effective project and time management skills and the ability to work under pressure
Preferred
Recent industry experience with clinical supplies or clinical operations
Experience with regulatory submissions a plus
Company
Pulmovant
Pulmovant develops investigational therapies for respiratory diseases and shares pipeline and clinical study information.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase