Supply Chain Study Lead

Supply Chain Study Lead

Remote / Ware

12 Month contract

Job Purpose:

The Supply Chain Study Lead (SCSL) role provides tactical oversight of the end-to-end supply chain for assigned GSK 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 GSK sponsored clinical studies as well as investigator sponsored trials and compassionate use studies.

Key Responsibilities:

1.      Builds and maintains strong working relationships as the primary interface with the clinical study teams

2.      Works with the Supply Chain Manager to understand and support the asset-level supply strategy

3.      Ensures accurate and timely communication to customer and partner organizations

4.      Works with cross-functional study team members to understand clinical requirements and over-arching study objectives

5.      Understands and challenges key assumptions and study planning parameters to ensure an optimal tradeoff across cost, risk, and benefit is achieved

6.      Proactively engages with Clinical study teams to ensure supply options & risks are explored and agreed.

7.      Develops different scenarios as needed to explore options and determine contingency plans

8.      Assists the Supply Chain Manager in developing costed, risk-based scenarios for supplies to enable informed decisions regarding budget allocation.

9.      Challenges planning information at the study level (e.g. patient enrollment forecast, etc.) and helps resolve logistical conflicts to ensure clinical supplies are off the critical path.

10.  Must be able to think and work innovatively to mitigate risks while working within the confines of supply chain capacity and capability.

11.   Influences change and/or challenges sourcing decisions when appropriate to do so.

12.  Creates and maintains detailed, study specific demand and supply plans for assigned studies.

13.  Develops, implements, and maintains the investigational product (IP) demand plans for assigned studies

14.  Models investigational product study demands based on varied study-specific inputs (e.g. patient enrolment forecast, treatment regimen, treatment duration, etc.)

15.  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

16.  Updates and adjusts study demand plans as each study progresses to account for variations from plan

17.  Develops, implements, and maintains the IP supply plan for assigned studies.

18.  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

19.  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

20.  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

21.  Accountable for contributing to the supply planning (PK) meeting as part of the monthly D&OP cycle

22.  Monitors expiry dating of clinical supplies and coordinates expiry extensions (if possible) or replenishment strategies and destructions if extensions are not possible.

23.  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

24.  Accountable for ensuring appropriate Interactive Response Technology (IRT) contract and setup is in place

25.  Determines the supply packing and distribution strategy for local, regional, and global studies, and incorporates into IVRS / IWRS specifications (as applicable)

26.  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.

27.  Executes supply plans that deliver on published study milestones while ensuring consistent on-time delivery of medicines to patients with minimal waste

28.  Engages with and influences cross-functional teams to coordinate and manage the delivery of clinical supplies for assigned studies.

29.  Timely communication and escalation of issues related to IP supply availability.

30.  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.

31.  Maintain appropriate documentation in accordance with GxP requirements and the Trial Master File

32.  Supports externalization activities where vendors and/or partners are included in the supply chain

33.   Create Study Specific Technical Agreements (or equivalent) for specified projects.

34.  Create inputs to vendor proposal request systems

REQUIRED Competencies:

•        B.S., M.S., Pharmacy, Chemistry or Logistics or equivalent experience in relevant field.

•        Knowledgeable of clinical trial study designs and approaches and their implications for supply chain

•        Knowledgeable in the management of investigational product supplies and experience in inventory management

•        Demonstrated working knowledge of supply chain and planning principles

•        Ability to manage multiple and complex projects that require strong problem solving skills and creative or innovative thought to address global supply problems

•        Knowledgeable in regulatory requirements including Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs) and the Trial Master File

•        Demonstrated understanding of the drug development process

•        Knowledgeable and experienced in working with Interactive Response Technology (IRT) systems, especially with respect to supply management and patient randomization.

•        Strong organizational and planning skills coupled with strong written and oral communication skills

•        Demonstrated capability to work with aggressive and changing timelines and with limited information and without defined absolutes.

•        Knowledge of the technical challenges with regards to investigational product packaging and labelling.

Preferred Qualifications:

•        APICS or CILT certification

•        Lean Sigma training / experience

•        Project Management training / experience

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