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Manager, Clinical Supplies
4 months ago
Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 7,000 employees are united around our mission of improving people’s lives with our health care products.
Supports the planning and organization of the working team and independently plans and organizes tasks to meet specified objectives and timelines. Manage the supply planning and delivery of development products by supporting clinical supply management, clinical supply packaging and labelling, IWRS, distribution, logistics planning and clinical supply budget development and tracking. Manage and execute the clinical supply chain for current and new clinical studies and programs.
**Responsibilities**
Additional representative responsibilities will include, but not necessarily be limited to, the following:
- Experience with any or all of the following functions or processes are highly preferred: clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, and inventory management.
- Own the coordination and execution of all clinical supply related activities including supply planning, cGMP secondary packaging/labelling, distribution, and logistics for R&D clinical programs
- Knowledge of clinical production processes and design strategy for patient kits to support the clinical study design.
- Support the IWRS User specifications and UATs.
- Execute clinical supply chain sourcing strategy utilizing 3rd party providers in coordination with clinical operations current and future programs
- Coordinate supplier relationships with clinical supply vendors to which includes maintaining key performance metrics and budget/invoice tracking, reviews initial supply needs for start-up, ongoing resupply strategy, contract negotiation and amendments and closeout requirements
- Evaluates vendor selection to support clinical studies according to capability and fit with outsourcing strategy and selection of contractors is made in agreement with line management. Generates RFPs for Vendor Proposals - Breakdown Protocols into component parts to support the supply strategy and communicate the study needs to obtain vendor based budgeting or internal support.
- Addresses budgets and invoicing considerations with vendors along with study management details and capture any impacts.
- Support business unit global supply chain in current and future clinical studies for clinical supply strategy and execution
- Assist in the management of the governance committee for global clinical operations and global clinical supply chain
- Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results
- Assist in the execution of clinical supply strategy for specific clinical programs
- Understanding of the roles and responsibility of all functions represented on cross functional drug development teams.
- Support of regulatory filings including IND submission information, regulatory audits and information to support regulatory audits. Provide regular updates to the TMF as per departmental and Corporate requirements that comply with all regulatory requirements.
- Participate in clinical study team meetings, align with study details, and collaborate in meeting study objective, and provide supporting information to the teams (includes RA, RACMC, Clinical Operations, Manufacturing and Development)
**Qualifications**
- Bachelor's Degree in science or business-related field; Masters/MBA in Operations preferred
- Minimum 5 years of experience handling / leading clinical supply chain and logistics; some development experience preferred
- Ability to rapidly navigate the organization and identify, align, and integrate cross-functional resources into cohesive teams
- Demonstrated ability to work in a highly matrixed environment is essential; ability to develop and lead a high performing team across all levels
- Experience in multi-functional areas (Clinical, Regulatory, Quality, Product/Process Development) demonstrating a broad understanding of pharmaceutical development, both in GCP and GMP.
- Expert knowledge of all phases of drug development, of the functions and processes relevant to drug development, and project management principles applicable to the biopharmaceutical environment
- Extensive in planning and execution of investigational materials supply strategies
- General knowledge of GxP principles is required
This is a non-supervisory position
This role includes oversight of Clinical Development Manufacturing Organization(CDMO)
