Associate Director Clinical Supply Study Lead

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 offices3 days a week in our Gaithersburg office. Our headofficeispurposely 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.

Essential Skills/Experience:

• We would be looking for minimum of a 4-year degreeand a minimum of 2 years of experience in clinical supply chain.

• 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.

Desirable Skills/Experience:

• 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.

The annual base pay (or hourly rate of compensation) for this position ranges from125056.8 to 187585.2 positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coveragein accordance withthe terms of the applicable plans.

At AstraZeneca we believe in the potential of our people and youll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As a Statistical Programming Director youll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients lives and join us on an exciting journey to pioneer the future of healthcare.

AstraZenecais an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing.

Why AstraZeneca:
Join a global engine room where clinical supply digital capability and operational excellence come together to accelerate medicines to patients. You will work at the intersection of science and operations using predictive analytics smart automation and data modelling to reimagine how trials run. Expect unexpected teams in the same room unleashing bold thinking a two-way exchange of ideas across a powerful network and the trust to take smart risks while doing the right thing. We value kindness alongside ambition and we back your growth with real opportunities to shape how our enterprise performs and how we contribute to patients and society.

Call to Action:
If you are ready to lead study supply at scale and turn innovative design into reliable delivery for patients step forward and help us set a new standard in clinical supply leadership.

Where can I find out more

• OurSocial Media Follow AstraZeneca on LinkedIn AstraZeneca on Facebook AstraZeneca on Instagram US Footprint: Powering Scientific Innovation - YouTube

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Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.