Position: Director, Clinical Supply
Summary: Pulmovant is seeking a leader in Clinical Supply who will provide planning and execution of Clinical Supply Chain activities to support Pulmovant clinical studies globally. This position coordinates operations including clinical packaging, labeling, and distribution. Responsible for actively managing all inventory, logistics and forecasting for the clinical program. This person will be the subject matter expert related to clinical drug supply during all phases of the clinical trial and will support activities leading to the implementation of global clinical inventory management, supply planning and distribution systems consistent with meeting cGMP, clinical development programs, corporate objectives and is responsible for vendor management including performance metrics.
KeyDuties and 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
- Act as primary liaison with contractor(s) (CMO's). Complete business and performance metrics
- 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
Education and Experience - Minimum of 8 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
- Recent industry experience with clinical supplies or clinical operations is preferred
EssentialSkills andAbilities - 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
- Experience with regulatory submissions a plus
- The duties of this role are generally conducted in a remote environment. As is typical of a remote-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours
