Job Description

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.:

• Builds and maintains strong working relationships as the primary interface with the clinical study teams
• Works with the Supply Chain Lead 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
• Understands and challenges key assumptions and study planning parameters to ensure an optimal tradeoff 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 Lead in developing costed, risk-based scenarios for supplies to enable informed decisions regarding budget allocation.
• 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.
• 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.
• 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
• Accountable for contributing to the supply planning (PK) meeting as part of the monthly D&OP cycle
• Monitors expiry dating of clinical supplies and coordinates expiry extensions (if possible) or replenishment strategies and destructions if extensions are not possible.
• Determines the supply packing and distribution strategy for local, regional, and global studies, and incorporates into IVRS / IWRS specifications (as applicable)
• 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
• 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
• 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
• Accountable for ensuring appropriate Interactive Response Technology (IRT) contract and setup is in place

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• B.S., Pharmacy, Chemistry or Logistics and min. 3 years in pharmaceutical field

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• APICS or CILT certification
• M.S., Pharmacy, Chemistry or Logistics in relevant field
• Lean Sigma training / experience
• Project Management training / experience
• Experience working with clinical trial study designs and approaches and their implications for supply chain
• Experience demonstrating knowledge 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.
• Experience demonstrating 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 labeling.

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Why GSK?

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

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