Job Description
Our client is an exciting, rapid growing clinical-stage biopharmaceutical business clearly focused on delivering significant quality-of-life improvements to patients in a therapy area that has seen no new treatments in many decades. Driven by a major increase in activity in their global business our client seeks to fill the newly created, permanent (hybrid-based) position of Clinical Supply Chain Specialist.
Reporting to the Director of Clinical Supply Chain, this position is responsible for supporting multiple Clinical Development Programs in all clinical study phases. The incumbent will bring a depth of expertise in clinical trial supply chain and will be responsible for oversight of the supply chain planning and execution for a medical device including ancillaries and a controlled drug being supplied to a broad range of clinical studies across Europe and US. In addition, the Clinical Supply Chain Specialist partners with CMC and Device to manage inventory of drug substance, drug product, device, and ancillaries through the program, developing appropriate systems and processes to manage inventory and maintain supply chain integrity.
Job Spec
- In partnership with key stakeholders from Clinical Operations, Medical, CMC/Manufacturing, Quality and Regulatory oversee the development of a Clinical Supply Plan that documents the study design, product requirements, and study assumptions e.g. enrolment, target countries, number of sites, etc. for each study included in a Clinical Program.
- Oversee the development of the clinical demand forecast on a study and program level and communicate this monthly to the key stakeholders to ensure seamless coordination of demand and supply.
- On an ad hoc basis prepare clinical demand/supply scenarios using different combinations of inputs and assumptions to project both short-term and long-term supply availability.
- Proactively identify issues with the potential to impact a clinical study and/or program and engage with key stakeholders to highlight risks and find solutions.
- Design clinical packaging requirements
- Monitor enrolment, drop-out rates and actual supply needs. Ensure continuous re-assessment of project needs.
- Drive label creation and approvals process, including translations for all countries.
- Support a vendor management process including RFP, and work orders with vendors.
- Support of regulatory filings including IND submission information, and audit from all health agencies.
- Monitor conformance to Clinical Supplies Inventory Management with Interactive Response Technology (IRT) standards where implemented.
- Design, implement and Oversee return and destruction of IMPs from sites.
- This exciting role requires an individual with relevant experience in clinical trial supply chain and capable of hitting the ground running.
- Experience with supply management of scheduled/controlled drugs an advantage with experience of US DEA requirements highly beneficial
- Strong organizational, communication, and decision-making skills.
- Ability to effectively interact with all levels of internal and external management, including CROs.
- Self-motivated with the ability to work in an unstructured environment.
- Proven record delivering successful results in multi-cultural and geographically diverse cross-functional teams.
- Flexible, able to adjust, embrace and drive change.
- An entrepreneurial, business-oriented mindset and willing to “roll their sleeves up.
- Resilient, energetic, and enthusiastic
CV to gavin@rftgroup.ie