Position: Senior Manager, Clinical Supply
Summary:Pulmovant is seeking a leader in Clinical Supply who will provide 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 and logistics 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 - Support all clinical supply activities for on-going and new clinical trials for on-time delivery, which includes protocol demand forecasting, pharmacy manual drafting, trial monitoring, initial and resupply planning, and distribution activities.
- Coordinate closely with Clinical Operations, CRO and sites to support enrollment and ongoing participant dosing.
- Assist in coordination with contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials ensuring compliance with cGxP requirements.
- Partner with CMC, Clinical Operations, QA and Regulatory to develop kits and label text for multiple countries/regions.
- Participate in and lead IXRS development efforts and system maintenance where applicable.
- Assist in development of risk mitigation plans to proactively identify any potential issues that may impact drug supply including process development for inspection readiness.
- Support 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.
- Coordinate with CMC team regarding logistics and movement of material globally to support manufacturing and drug development.
Education and Experience - Minimum of 5 years of related experience in the pharmaceutical industry with at least 2 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.
- 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.
- 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.
We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!
