Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. The company is privately held, has in-licensed 45+ assets, and is very well-capitalized. The ACES team (Advanced Clinical Evaluation and Strategy) works hand in hand with Business Development and the Chief Medical Offer to establish the scientific rationale and initial development strategy for novel drug in-licensing opportunities.
The Senior Manager/Associate Director is responsible for management of inventory, logistics, clinical supply (packaging, labeling and distribution) and supply chain operations to support the execution of clinical trials for development projects for Roivant and its subsidiaries (Vants) Responsibilities include supply chain strategy development, packaging and labeling vendor selection, vendor management for clinical supply manufacture, packaging, labeling, distribution of clinical trials materials in an outsourced environment, and due diligence support. Responsibilities also include inventory management for drug substance, raw materials, and drug product as well as label development for global clinical trials. Associated responsibilities include import/export management related to clinical supplies and inventory. The Manager/Senior Manager/Associate Director closely works with internal teams and vendors to seamlessly integrate supply chain operations into the integrated project plan and clinical operations. The Manager/Senior Manager/Associate Director manages Roivant CMC vendor relationships to ensure strategic alignment and maintain oversight of project execution. He/She is responsible for working with vendors to develop timelines, budgets, and work with the Roivant PM to integrate the plans into the master plan.
The Senior Manager/Associate Director collaborates with CMC, Legal, Quality, Regulatory, Clinical, Commercial, Project Management and development teams to assure appropriate strategic and tactical efforts are executed in support of global clinical studies and regulatory submissions.
They will be required to assess supply chain technical, budget and timeline risks and develop mitigation plans. The incumbent also performs due diligence with a view to understand the available inventory, vendors, develop supply chain maps and clinical supply plans.
They manage vendor selection for packaging/labeling/distribution activities and manages these activities for new and ongoing global clinical trials. Activities include supply planning, packaging and blinding design, label generation, review and approval of batch records, etc.
They must make effective decisions and ensure that such decisions are made in a collaborative, timely and expeditious manner as well as develop corrective action plans and implement such plans to resolve complex project issues.
The incumbent, develops and maintains project schedules and budgets. He/she ensures that verbal and written communications are clear, concise, and consistent across multiple scientific and business functions which results in building effective relationships with internal and external customers.
- Lead CMC supply chain aspect of product development including supply chain technical due diligence on assets of interest and supply chain strategy development from project initiation through commercialization and execution using external vendors.
- Manage external collaborations for inventory storage, shipping logistics, labeling storage and distribution of clinical supplies for development projects.
- Partner a cross-functional project team to ensure that clinical supply timelines are in place and aligned with the project’s overall objectives. Manage timelines, budgets, vendor relationships and team updates
- Proactively collaborate with QA and other members of the project team to efficiently evaluate, select, and manage contract service providers for packaging, labeling, storage, and distribution of clinical supplies and other incentory. This includes batch record reviews for packaging and labeling, deviations, investigations, label development, change controls, shelf-life extensions, CAPAs, and temperature excursion management
- The incumbent is expected to work with QA and be familiar with our Veeva quality management system. and temperature excursions.
- The incumbent works closely with CMC project leads in development of specifications and clinical supply labels
- Closely manage contract laboratories and contract manufacturers as required
- Closely manage the overall clinical supply timeline, budget and operations
- Contribute to the relevant sections of the pharmacy manual and investigational drug brochure
- Work with QA and the quality management system (Veeva)
- Manage the development and execution of master packaging records and supporting documentation for clinical supplies.
- BS/Msc/Ph.D. in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or closely related field and 5yr+ experience in the clinical supply management.
- Must have demonstrated leadership experience in managing diverse project activities with contract vendor facilities and global clinical supply operations
- Knowledge of cGMP regulations, ICH guidelines, and global supply chain operations related to clinical studies
- Intellectual agility - able to pivot based on shifting priorities and balance multiple projects seamlessly
- Natural collaborator who enjoys working on a cross-functional team
- Demonstrated communication, problem-solving, and negotiation/decision-making skills
- Must be a self-starter and able to work independently