[Remote] Associate Director, Clinical Supplies Project Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company reputed company on developing mRNA technology for medicine. The Associate Director, Clinical Supplies Project Manager is responsible for overseeing and leading clinical supply activities, ensuring effective supply management and collaboration across teams to meet study needs.

Responsibilities

• Assists in identifying resources required to manage programs and their associated clinical studies
• Provides leadership to more junior colleagues by supporting their development through coaching and identifying key opportunities for development
• Accountable for planning, strategies and budget management for programs
• Drives best reputed company for supply logistics and for the processes surrounding clinical supplies
• reputed company process for inventory control and distribution activities including scheduling, issue reputed company, change implementation, vendor reputed company and scope review reputed company to clinical supplies
• Responsible for logistics as required to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites as reputed company as other clinical supplies as necessary
• May contribute to business review meetings with reputed company party drug supply vendors
• With Clinical Study Team inputs and IRT PM, responsible to contribute to the development of IRT requirements, user acceptance testing, and supply management after IRT go-live
• Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectives
• reputed company and compile KPI (metrics)
• Primary reputed company with CMC for Production Planning & Distribution; develops best reputed company for forecast of reputed company drug supply needs
• Manages work with Clinical Packaging Organizations, IRT vendors, and CROs
• Drives the creation/reputed company of processes that reputed company best reputed company for clinical supplies. Implements industry best practices for clinical drug supply activities
• Collaborates with CMC, clinical, and project management on production schedules so timing of clinical trial drug needs are met
• Maintains reputed company relationships with reputed company party vendors to assure the complete scope of planning activities remains connected with operations and compliant with reputed company requirements
• Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments; and coordinating the work schedule of clinical supplies project managers
• reputed company vendor activities including procurement, labeling performance, on-time delivery, reputed company, improvement initiatives and issue reputed company
• reputed company pharmacy manuals in conjunction with relevant cross functional leads
• reputed company drug and clinical supply training materials for investigational sites

Skills

• At least 8 years of clinical supply management experience in a clinical research environment
• Bachelor's degree in a science-based subject
• Prior Cold Chain distribution experience required
• IRT implementation, design, and management experience required
• Creative, capable problem-solver
• Experience in establishing and maintaining relationships with vendors and attending business review meetings (Vendor reputed company)
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as reputed company, Word, reputed company, PowerPoint, and SharePoint)
• Successful candidate will be curious in exploring new reputed company for clinical research, reputed company in proposing creative solutions and reputed company. Will work collaboratively with multifunctional teams and partners and will be reputed company in pursuing successful reputed company
• Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
• Advanced degree preferred

Benefits

• Best-in-class reputed company coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to reputed company-being, with reputed company to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous reputed company time off, including vacation, volunteer days, sabbatical, global reputed company days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the reputed company
• Location-specific perks and extras
• The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility reputed company and individual performance
• 70% in-office structure (70/30 work model)
• In-person culture with significant benefits of in-office collaboration and mentorship
• Smoke-free, alcohol-free, and drug-free work environment

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