Supply Chain Study Lead

Site Name: USA - Pennsylvania - Upper Providence, Belgium, GSK HQ, Ware, Zebulon

Posted Date: Sep 30 2024

Supply Chain Study Lead

Job Purpose: Describe why job exists / what it must achieve

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:

• 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

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

• 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.

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

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

• 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

• 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

• 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.

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

• Create inputs to vendor proposal request systems.

Why you?

Basic Qualifications:

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

• B.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 labeling.

Preferred Qualifications:

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

• Bachelor's degree in Logistics/Supply Chain

• APICS Certification, Black or Green Belt, Lean Sigma Certification

• Strong analytical skills

• Ability to work in a matrix organization

• Strong influencing skills

• Ability to simplify complex processes

• Effective verbal and written communication skills, including presentation skills

• Knowledge of enterprise resource planning systems

• Sense of urgency, flexibility and accountability

• Enterprise thinker (end-to-end supply orientation, cross functional team spirit, sharing of good practices within the network)

• Proven planning and organizational skills

• Ability to lead and drive change

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk .

• Managing individual and team performance.

• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

• Implementing change initiatives and leading change.

• Sustaining energy and well-being, building resilience in teams.

• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.

• Developing people and building a talent pipeline.

• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.

• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

• Budgeting and forecasting, commercial and financial acumen.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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