Associate Director Clinical Supply Study Lead

AstraZeneca•Gaithersburg, MD

1d•Hybrid

About The Position

Introduction to role: Are you ready to orchestrate end-to-end clinical study supply so every site has the right medicine at the right time, with less waste and lower cost? In this role you will translate study designs into resilient, data-driven supply chains that keep trials moving and patients on therapy. You will partner closely with clinical, CMC, QA, analytics and digital specialists to shape supply strategy from protocol concept through close-out. By combining deep functional expertise with modern tools such as IRT, the N-Side Suite and our Smart Supplies platform, you will reduce risk, enable smarter randomization, and accelerate decision-making. Do you see yourself guiding experienced peers, lifting standards across a global community, and turning improvement ideas into enterprise practice? Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week in our Gaithersburg office. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Accountabilities: Study Delivery Optimization: Execute study delivery using robust planning processes to optimize service, reduce waste and manage cost impact, ensuring uninterrupted investigational product supply to sites. Mentorship and Community Leadership: Mentor, support and coach already experienced Clinical Supply Study Leads managing complex and demanding studies to set up and execute supply in an optimized way; foster knowledge sharing across the global community. Business Development and Digital Capability: Lead or be a key contributor in business development projects and initiatives, especially in supply chain excellence and digital capability, and drive implementation within the CSSL community. Process Ownership: Serve as business process owner for defined supply chain processes, setting standards and driving adoption that improves quality, speed and consistency. Continuous Improvement: Drive improvement initiatives that streamline forecasting, labeling, distribution and change management; measure and communicate outcomes. Risk Management: Identify, manage and mitigate risks across studies and the broader area; escalate issues through appropriate channels to protect patient supply and study timelines. Lean Leadership: Act and promote according to Lean Leadership Habits and Behaviours to enable fast learning cycles and better outcomes. Study Design Influence: Provide input to Study Design Concept, Clinical Study Protocol, Handling Instructions, Pharmacy Manual and related documents; collaborate with Design specialist and IRT specialist teams to agree optimum supply chain design using the N-Side Suite to optimize IRT settings; contribute to randomization strategy. Stakeholder Management: Lead the Study Drug Working Group to enable continuous dialogue on study design requirements and changes; contribute to Supply Chain Team meetings and ensure effective collaboration with Dev QA, Analytical, CMC, SCPL and Clinical partners; lead or contribute to supplier kick-off meetings (PLD, clinical CRO, IRT) and maintain productive partnerships; support outsourced studies and partner with CSOS colleagues. Demand and Supply Planning: Develop and input to key documents reflecting supply chain design and requirements (SSSD or equivalent, SDPA, PSF); deliver refined initial and continuous demand forecasting; create supply plans for secondary packing; execute change management (label changes, expiry switches); manage inventory to reduce waste. Cost and Waste Management: Assess projected costs for packaging, labelling and distribution in line with the AQIRE process; control ongoing study spend via PO and invoice approval; flag risks related to budget constraints via SCT. Compliance and Quality: Manage Quality Events (Deviations, CAPAs, Complaints, Change Control); contribute to GMP and GCP audits; provide regular updates during TIER meetings according to SQSCP (SHE, quality, supply, cost, people) priorities; ensure eTMF compliance; complete OOD reporting. System Utilization: Leverage IRT, the Smart Supplies platform and the N-Side Suite to design, simulate and operate efficient clinical supply chains. Packing, Labelling and Distribution: Define and implement PLD strategy; lead kit/pack design; implement TCM and manage the strategy; develop Master Labels (as relevant); oversee destruction management, expiry date management, shelf life extension, rework and recalls. GMP Responsibilities and Training: Once fully trained and experienced per relevant GMP checklists, carry out associated GMP work and act as Trainer/Mentor; conduct activities consistent with Company values and Code of Conduct, completing all required training and reporting potential issues of non-compliance.

Requirements

We would be looking for minimum of a 4-year degree and a minimum of 2 years of experience as a clinical supply study lead
Execute study delivery, following planning processes to optimize service, waste and cost impact.
Mentor, support and coach already experienced CSSLs managing complex and demanding clinical studies to set up and execute supply in an optimized way.
Lead or be a key contributor in business development projects or initiatives, especially in the areas of supply chain excellence and digital capability, and drive implementation in the CSSL community.
Serve as business process owner for a defined supply chain process.
Drive improvement initiatives; identify, manage and mitigate risks in studies and the business area; act and promote according to Lean Leadership Habits and Behaviours.
Provide input to Study Design Concept, Clinical Study Protocol, Handling Instructions, Pharmacy Manual and other relevant documents; work with Design specialist and IRT specialist teams to agree optimum supply chain design using the N-Side Suite to optimize IRT settings; input to randomization strategy.
Lead the Study Drug Working Group; contribute to Supply Chain Team Meetings; lead/contribute to supplier Kick Off Meetings (PLD, clinical CRO, IRT) and maintain collaboration throughout the study lifecycle; escalate risks/issues/concerns relating to systems and activities; support outsourced studies and partner with CSOS colleagues; support knowledge sharing across Global Clinical Supply Chain.
Deliver demand and supply planning: develop/input to SSSD (or equivalent), SDPA, PSF; perform refined initial and continuous study demand forecasting to create supply plans for secondary packing; execute change management; lead inventory management to reduce waste.
Manage cost: assess projected costs related to packaging, labelling and distribution in line with the AQIRE process; control ongoing study spend via PO and invoice approval; flag risks related to budget constraints via SCT.
Ensure compliance: manage Quality Events (Deviations, CAPAs, Complaints, Change Control); contribute to GMP and GCP audits; provide regular updates during TIER meetings according to SQSCP priorities; ensure eTMF compliance; conduct OOD reporting.
Utilize core systems: IRT; Smart Supplies platform; the N-Side Suite.
Deliver PLD and distribution activities: define and implement PLD strategy; kit/pack design; implement TCM and manage the strategy; Master Label development (if relevant); destruction management; expiry date management; extension of shelf life; rework and recalls.
Perform GMP activities once fully trained according to the relevant checklist; act as Trainer/Mentor; conduct activities and interactions consistent with the Code of Conduct and supporting Policies and Standards.

Nice To Haves

Proven leadership of complex, global clinical studies with measurable reductions in waste and cost through forecasting, inventory optimization and expiry management.
Demonstrated success leading cross-functional Study Drug Working Groups and external partners (PLD, clinical CRO, IRT) across multiple time zones.
Track record implementing digital capability improvements in clinical supply, using tools such as the N-Side Suite to optimize IRT settings and scenario planning.
Experience serving as a business process owner, defining and embedding standards across a community of practice.
Hands-on experience with AQIRE-aligned cost assessments, TIER/SQSCP updates, and eTMF compliance monitoring.
Depth in GMP/GCP, including management of Deviations, CAPAs, Complaints, Change Control, and readiness for audits.
Comfortable acting as Trainer/Mentor for GMP activities and coaching peers in Lean Leadership Habits and Behaviours.

Responsibilities

Execute study delivery using robust planning processes to optimize service, reduce waste and manage cost impact, ensuring uninterrupted investigational product supply to sites.
Mentor, support and coach already experienced Clinical Supply Study Leads managing complex and demanding studies to set up and execute supply in an optimized way; foster knowledge sharing across the global community.
Lead or be a key contributor in business development projects and initiatives, especially in supply chain excellence and digital capability, and drive implementation within the CSSL community.
Serve as business process owner for defined supply chain processes, setting standards and driving adoption that improves quality, speed and consistency.
Drive improvement initiatives that streamline forecasting, labeling, distribution and change management; measure and communicate outcomes.
Identify, manage and mitigate risks across studies and the broader area; escalate issues through appropriate channels to protect patient supply and study timelines.
Act and promote according to Lean Leadership Habits and Behaviours to enable fast learning cycles and better outcomes.
Provide input to Study Design Concept, Clinical Study Protocol, Handling Instructions, Pharmacy Manual and related documents; collaborate with Design specialist and IRT specialist teams to agree optimum supply chain design using the N-Side Suite to optimize IRT settings; contribute to randomization strategy.
Lead the Study Drug Working Group to enable continuous dialogue on study design requirements and changes; contribute to Supply Chain Team meetings and ensure effective collaboration with Dev QA, Analytical, CMC, SCPL and Clinical partners; lead or contribute to supplier kick-off meetings (PLD, clinical CRO, IRT) and maintain productive partnerships; support outsourced studies and partner with CSOS colleagues.
Develop and input to key documents reflecting supply chain design and requirements (SSSD or equivalent, SDPA, PSF); deliver refined initial and continuous demand forecasting; create supply plans for secondary packing; execute change management (label changes, expiry switches); manage inventory to reduce waste.
Assess projected costs for packaging, labelling and distribution in line with the AQIRE process; control ongoing study spend via PO and invoice approval; flag risks related to budget constraints via SCT.
Manage Quality Events (Deviations, CAPAs, Complaints, Change Control); contribute to GMP and GCP audits; provide regular updates during TIER meetings according to SQSCP (SHE, quality, supply, cost, people) priorities; ensure eTMF compliance; complete OOD reporting.
Leverage IRT, the Smart Supplies platform and the N-Side Suite to design, simulate and operate efficient clinical supply chains.
Define and implement PLD strategy; lead kit/pack design; implement TCM and manage the strategy; develop Master Labels (as relevant); oversee destruction management, expiry date management, shelf life extension, rework and recalls.
Once fully trained and experienced per relevant GMP checklists, carry out associated GMP work and act as Trainer/Mentor; conduct activities consistent with Company values and Code of Conduct, completing all required training and reporting potential issues of non-compliance.