Job Description
The Supply Chain Study Lead (SCSL) role provides tactical oversight of the end-to-end supply chain for assigned R&D clinical studies. The SCSL is accountable for defining detailed demand and supply plans for investigational medicines that consistently deliver those medicines on-time to patients while ensuring the supply chain delivers results that support published study milestones.
This role is responsible for reviewing and influencing clinical protocols relative to investigational product (IP) supply and determining optimal supply plans that are patient-focused, risk-adjusted, and cost effective.
Furthermore, the SCSL ensures timely execution of the plans and follows through on supply chain performance to ensure the successful delivery of the supply chain.
This role supports Phase I through IV sponsored clinical studies as well as investigator sponsored trials and compassionate use studies.
Responsibilities:
1. Builds and maintains strong working relationships as the primary interface with the clinical study teams. Works with the Supply Chain Manager to understand and support the asset-level supply strategy. Ensures accurate and timely communication to customer and partner organizations. Works with cross-functional study team members to understand clinical requirements and over-arching study objectives
2. Understands and challenges key assumptions and study planning parameters to ensure an optimal trade-off across cost, risk, and benefit is achieved.Proactively engages with Clinical study teams to ensure supply options & risks are explored and agreed: Develops different scenarios as needed to explore options and determine contingency plans. Assists the Supply Chain Manager in developing costed, risk-based scenarios for supplies to enable informed decisions regarding budget allocation.
3. Challenges planning information at the study level (e.g. patient enrolment forecast, etc.) and helps resolve logistical conflicts to ensure clinical supplies are off the critical path.Must be able to think and work innovatively to mitigate risks while working within the confines of supply chain capacity and capability. Influences change and/or challenges sourcing decisions when appropriate to do so.
4. Creates and maintains detailed, study specific demand and supply plans for assigned studies. Develops, implements, and maintains the investigational product (IP) demand plans for assigned studies. Models investigational product study demands based on varied study-specific inputs (e.g. patient enrolment forecast, treatment regimen, treatment duration, etc.). Creates and maintains detailed demand plans for each assigned study for the full duration of patient treatment and ensures full visibility of requirements in relevant planning systems. Updates and adjusts study demand plans as each study progresses to account for variations from plan. Develops, implements, and maintains the IP supply plan for assigned studies. Accountable for creating supply plans based on study parameters, forecasts, and assumptions through to depots and ensures full visibility of requirements in relevant planning systems. Works with the Supply Chain Planner to ensure IP supply requirements are visible from finished Patient Kit (PK) to Active Pharmaceutical Ingredient (API) as appropriate. Accountable for setting inventory policies at Depots / Pack Sites on a project basis and responsible for agreeing to and monitoring inventory levels as appropriate to support study complexities.
5. Accountable for ensuring that label content is defined and the data is set-up in the appropriate system(s) and liaising with relevant groups on pack design and pack component suitability.
6. Accountable for ensuring appropriate Interactive Response Technology (IRT) contract and setup is in place.Determines the supply packing and distribution strategy for local, regional, and global studies, and incorporates into IVRS / IWRS specifications (as applicable).
7. Works with business partners to oversee the effective execution of supply chain plans while proactively identifying potential obstacles to success and taking action to resolve issues. Executes supply plans that deliver on published study milestones while ensuring consistent on-time delivery of medicines to patients with minimal waste Engages with and influences cross-functional teams to coordinate and manage the delivery of clinical supplies for assigned studies. Timely communication and escalation of issues related to IP supply availability. Accountable for complex problem solving and resolution of issues involving a range of technical, quality, regulatory and operational issues to ensure patient supply without compromising quality, cost or delivery. Maintain appropriate documentation in accordance with GxP requirements and the Trial Master File
8. Supports externalization activities where vendors and/or partners are included in the supply chain. Create Study Specific Technical Agreements (or equivalent) for specified projects. Create inputs to vendor proposal request systems.
Profile
9. B.S. or M.S. in Pharmacy, Chemistry or Logistics or equivalent experience in relevant field.
10. 5-7 years of experience in clinical trial study designs and approaches and their implications for supply chain.
11. Knowledgeable in regulatory requirements including Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs) and the Trial Master File (TMF).
12. APICS (American Production and Inventory Control Society) or CILT (International Certificate in Logistics and Transport) certification.
13. Lean Sigma training / experience.
14. Project Management training / experience.
15. Knowledgeable in the management of investigational product supplies and experience in inventory management .
16. Demonstrated working knowledge of supply chain and planning principles.
17. Ability to manage multiple and complex projects that require strong problem solving skills and creative or innovative thought to address global supply problems.
18. Demonstrated understanding of the drug development process.
19. Knowledgeable and experienced in working with Interactive Response Technology (IRT) systems, especially with respect to supply management and patient randomization.
20. Strong organizational and planning skills coupled with strong written and oral communication skills.
21. Demonstrated capability to work with aggressive and changing timelines and with limited information and without defined absolutes.
22. Knowledge of the technical challenges with regards to investigational product packaging and labelling.
What we offer
At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.
We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.