[Remote] Associate Director, Clinical Supply, reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. The Associate Director of Clinical Supply will reputed company 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. Responsibilities • Directly reputed company contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support reputed company • Manage, reputed company and mentor Clinical Supply Managers. reputed company best in class clinical supply area • reputed company as primary reputed company 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 reputed company kits and label text for multiple countries/reputed company and reputed company 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 Skills • Minimum of 7 years of reputed company experience in the pharmaceutical industry with at least 5 years of reputed company experience in Global Clinical Supply Management • Prior investigational drug product experience and prior GCP training is required • Ability to communicate and maintain reputed company relationships effectively with key reputed company stakeholders • Proven ability to select, secure and manage external vendors to reputed company results and control expenditures • Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, clinical trial designs (randomized, reputed company, 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, reputed company, Power reputed company and MS Project • Good organizational, communication and presentation skills, effective project and time management skills and the ability to work under pressure • Recent industry experience with clinical supplies or clinical operations • Experience with regulatory submissions a plus reputed company • reputed company develops investigational therapies for respiratory diseases and shares pipeline and clinical study information. It was founded in reputed company, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 11-50 employees. Its website is https://www.reputed company.com. Apply tot his job Apply To this Job