Senior Specialist, Clinical Supply Chain

Role Summary

Senior Specialist, Clinical Supply Chain role focusing on effective management of drug manufacturing and the clinical supply chain across the clinical portfolio, ensuring seamless provision of drug and ancillary supplies. Works with internal teams to assist in delivering clinical supplies in line with regulatory requirements and internal quality processes.

Responsibilities

• Leads and provides direction around Supply Chain discussions in team meetings, with effective communication with customers and partners
• Sets up the clinical supply chain strategy for studies and/or clinical portfolio of studies
• Designs and implements labelling, packaging and supply strategies that meet study design, sites, and regulatory requirements while maximizing supply efficiency
• Manages, with input from CMC and Regulatory groups, the generation and approval of label texts, translations, and label proofs
• Produces a clinical supply agreement document detailing design, setup, and operation of the supply chain for responsible studies or groups of studies
• Ensures supply chain strategy delivers clinical supplies effectively, balancing cost and risk
• Seeks input and support from cross-functional groups
• Translates clinical protocol requirements into demand for study and aggregates demand for program of studies when applicable
• Monitors budgets for individual study activities and materials; contributes to reviews and flags deviations
• Reviews changes to contracts with vendors as necessary
• Works with other Clinical Supply Chain team members to resolve issues and share best practices
• Monitors performance of the supply chain strategy and optimizes it balancing speed, quality and cost with respect to risk
• Acts as point of contact and manages relationships with IRT, packaging, labeling and distribution vendors
• Manages labeling, packaging and distribution activities including review/approval of records and distribution plans
• Manages procurement and distribution of IMP and ancillary materials ensuring regulatory requirements are met
• Ensures seamless provision of supplies by carrying out distribution-related activities
• Management of drug temperature excursions during shipment and storage
• Drug usage forecasting across the clinical portfolio
• Contributing to design and testing of IRT systems during study setup
• Administration and monitoring of IRT systems for drug supply demands
• Arranging and monitoring depot and site shipments as required
• Troubleshooting site clinical pharmacy issues
• Management of shelf-life/expiry updates of all clinical supplies
• Management of activities relating to accountability, reconciliation, return and destruction of clinical supplies
• Management and review of inventory levels at facilities, hubs and depots to ensure adequate supplies
• Ensures documentation is filed appropriately in Trial Master File or controlled systems; records are inspection-ready
• Supports preparation, review and formatting of documents for clinical trials (pharmacy handling instructions, distribution project specifications, etc.)
• Supports compliance with Quality Management system, including writing/reviewing SOPs
• Contributes to and reviews documents for regulator or ethics committee submissions when required
• Supports supplier selection and documentation related to CMOs, distribution depots, and contractors
• Presents and trains on clinical supply material to trial personnel or investigators; may require travel
• Contributes to and reviews supply and technical agreements, ensuring Quality oversight
• Provides guidance to more junior personnel
• Initiates Quality Events and conducts root cause analyses with CAPAs

Qualifications

• Essential: Worked within pharmaceutical quality systems with understanding of good practice principles
• Essential: Extensive industry experience in drug development
• Essential: Ability to work collaboratively and influence stakeholders; meet deadlines within scope and budget
• Essential: Strong organizational skills and track record in running clinical study projects
• Desirable: Design, testing, implementation and management of IRT systems for multi-regional studies
• Desirable: Interpersonal skills with experience managing external CROs; experience in early phase trials; oncology knowledge; GMP or clinical supplies experience
• Desirable: Knowledge of ICH GCP; drug usage forecasting/supply and demand; matrix environment experience; budgeting experience

Skills

• Communication proficiency in local language
• Professional discretion and confidentiality
• High prioritization and time management
• Self-motivation and autonomy
• Ability to anticipate challenges and devise strategies
• Result- and deadline-oriented
• Collaboration and teamwork
• Presentation skills
• Personal effectiveness and credibility
• Flexibility and technical capacity
• Stress management and composure

Education

• Degree or higher in a relevant scientific subject
• Master's or PhD in a relevant scientific subject preferred
• Computer skills: MS Word, Excel, PowerPoint, Outlook, MS Project, SharePoint