Job Description
This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.
Our client is a clinical-stage neuroscience company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, life-threatening diseases
Reporting to the Vice President of Technical Operations, the Director, Clinical Supply Chain will be responsible for the uninterrupted supply of study drug to our client’s clinical programs.
The role will require close interaction with Technical Operations CMC Program Directors, Clinical Operations and Quality Assurance to translate projected enrolment data into a comprehensive clinical supply plan encompassing Drug Substance, Drug Produce and Labelling and Packaging. The incumbent will further be responsible for selecting and managing the appropriate label pack and clinical logistics solution based on study needs. This is a high-profile role with many touch points within the organization and is critical to the success of the company’s mission of bringing innovative therapies to patients.
Job Spec
- Clinical Planning - Partners with Clinical Operations and Technical Operations Program Directors to produce a comprehensive clinical supply plan for clinical studies
- Packaging and Labelling – Identifies, recommends and manages clinical packaging and labelling solution based on study needs, with special consideration to clinical requirements of kit assembly.
- Clinical Logistics – Manages clinical logistics, including vendor selection, to ensure timely supply of study drug to clinical sites, liaises with Quality Assurance to ensure this is carried out in full compliance with GMP/GDP regulations and principles.
- Risk Management - Proactively identify and manage supply risks including updating relevant stakeholders and/or escalation to executive leadership for information or action, when appropriate.
- Reporting - Ensures that regular timely reporting of cycle times and inventory on a Program and Global basis
- Continuous improvement – Continually strive to improve timeliness of delivery, reduction of cost, increase clinical supply flexibility and minimize cycle times
Person Spec
- B.S./M.S. degree or higher, preferably in Life/ Physical Sciences
- Qualification in Supply Chain or APICS required, although extensive experience may be considered for the right candidate
- 10+ years’ experience in a Supply Chain/ Manufacturing environment in the biopharmaceutical industry
- 5+ years of in-depth biopharmaceutical industry experience of supply chain planning and logistics for complex clinical programs
- Thorough knowledge of customs and international shipping regulations, as well as hands on experience of handling international customs authorities
- Experience of working in virtual organization and handling third party, clinical packagers, logistics providers, warehousing and brokers
- Knowledge and use of advanced planning techniques and software
- Ability to analyse complex data, perform scenario planning, summarize findings in a concise manner
- Excellent written and verbal communication; strong presentation skills
- Ability to deal with incomplete information or ambiguity in a composed manner
- Self-organized with strong critical thinking and analytical skills
- Ability to develop strong relationships with external CMOs and internal stakeholders Proficient with Microsoft Office (e.g. Word, PowerPoint, Excel) and Microsoft Project
Cv to gerry@rftgroup.ie 01 2302400