The Senior Manager, Clinical Supply Chain Program Lead will be a leader of cross-functional supply chain teams and representative of the Clinical Supply Chain function ensuring the effective management of drug production planning activities and the clinical supply chain, ensuring seamless provision of drug and ancillary supplies across the clinical portfolio.
As the primary Clinical Supply Chain contact with internal partners, the Senior Manager, Clinical Supply Chain Program Lead will work closely with Clinical Operation, Regulatory, Medical Affairs, Portfolio and Project Management and manufacturing colleagues to assist in the delivery of clinical supplies, while improving the use of resources in developing supply strategy within agreed time, volume, and cost, in line with relevant national and international requirements, ethical requirements and internal quality processes.
Responsibilities
- Sets up the clinical supply chain strategy and strategic direction of supply for clinical programs
- Leads Clinical Supply Chain Managers/ Specialists responsible for the production, packaging, labelling and distribution of drug supplies for clinical studies, providing direction around study supply strategies, ensuring plans are appropriately aligned with business needs
- Ensures the supply chain strategy maximizes efficiency of supply, consistently balancing cost and risk
- Aggregates the demand for Clinical program supply and ensures it is included in the CMC and External Manufacturing supply planning process
- Produces and implements a Clinical Supply Chain Program Strategy document documenting the supply chain program strategy
- Implements continuous improvement aimed at scalability and applicability across programs
- Supports requests for supply for external sponsor studies, compassionate use and access programs, collaborating with and seeking expert input from cross functional subject matter experts (e.g., Regulatory Sciences, Clinical Sciences, Commercial) as necessary
- Monitors and is responsible for communicating the spend versus budget for clinical supply program activities and materials, leads Clinical Supply Chain and Finance review meetings and flags variances
- Reviews changes to contracts with vendors and Contracts Manager if necessary
- May manage the procurement of IMP and ancillary materials as it relates to programs
- Manages and reviews inventory levels at manufacturing facilities, to ensure supplies are adequate according to the demand
- Provides support to ensure compliance with internal Quality Management system, including writing and reviewing SOPs
- When required, contributes to and reviews documents for submissions to regulators or ethics committees
- Contributes to and reviews supply and technical agreements, ensuring Quality oversight
- Initiates Quality Events where appropriate and investigate and perform root cause analysis and execution of associated CAPAs
- May deputize for the Director, Clinical Supply Chain when absent as required
- Supports the selection of suppliers and assist with the preparation of documentation associated with the assessment, evaluation and management of CMOs, distribution depots and other contractors involved with clinical supplies
- Drives forward procedural change to improve compliance with SOPs/ regulations
Supervisory Responsibility
This position does not include line manager responsibilities; however, it will include oversight of indirect report(s) by providing:
- Guidance regarding study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate
- Direction for ensuring study supply deliverables and milestones are met with quality and within timelines
- Direction and support to ensure consistent approach and process to study execution and procedures amongst various program assets
- Support and escalation point as needed
Qualifications
- Significant experience in the provision and management of clinical supply chains and associated activities
- Project management, and excellent organizational skills and attention to detail
- Strong interpersonal skills and effective communication with customers and partners
- Experience of cold chain supply management and biopharmaceuticals
- Thorough understanding of GxPs and global regulatory requirements related to clinical supplies
- Demonstrated experience working with technical systems
- Experience working in a dynamic, matrix environment
- Experience working with managing and forecasting budgets
- Experience of drug usage forecasting/ supply and demand
- Experience in managing cross-functional aspects of project delivery
- Ability to work independently under general supervision
- Strong understanding of the drug development process
- Experience in technical aspects of delivering biopharmaceutical products to the clinic
- Worked in all phases of clinical trials, including post-launch
- Experience in combination-device drug projects
- Knowledge and experience in Oncology and Autoimmune therapeutic disciplines
- Experience working in a dynamic environment and collaborating with cross-functional teams to deliver complex projects.
- Degree or higher degree in a relevant scientific subject or business management, or equivalent relevant and appropriate industry experience
- Desirable: Masters or PhD in a relevant scientific subject
- Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)