Supply Chain Study Manager Job Listing at AstraZeneca in Gaithersburg, Maryland (Job ID 1410051635)

AstraZeneca

AstraZeneca

Location: Gaithersburg, Maryland
Application deadline: None
Type: Not specified
Career Level: Mid-Senior Level
Salary Range: Not specified
Number of Jobs: 1
Relocation Available: No
Show all jobs for AstraZeneca
Industries
Biotechnology, Science/Research
Description

The Supply Chain Study Manager (SCSM) role is a key leadership role within RD Supply Chain. The role holder will manage the supply chain for a portfolio of global clinical studies across all phases within a drug development programme. He / she will lead cross-functional Study Drug Delivery Teams and represent these teams on the RD Supply Chain Team. The SCSM works in collaboration with customer functions to influence and manage demand for individual studies, and is responsible for their supply chain deliverables through leadership of the Study Drug Delivery Team.

Accountabilities/Responsibilities
Leadership
Leads and provides direction to Study Drug Delivery Teams (SDDTs) comprising members of RD SC, Clinical Development and external partners. Ensures SDDTs operate within boundaries set by Supply Chain Teams. Represents the Study Drug Delivery Team activities for all studies within a programme on the Supply Chain project team.
 Ensures team delivers clinical supplies effectively and consistently, balancing cost and risk to supply.
 Ensures expert input and support from cross functional groups.
Ensures effective communication within the SC and with customers and SC partners. Establish and lead risk management of individual studies during the planning phase, with proactive mitigation of risks threatening quality or delivery of supplies. Escalate significant issues to SCT as appropriate
Individual
Understands and translates clinical study protocol requirements into demand for drug product within a clinical study including requirements for placebo, comparators and rescue / challenge medication. Author the drug supply section of Clinical Study Protocol and lead development of master label text.
Use simulation tools and supply chain expertise to design optimised, lean supply chains for individual studies, defining allocation of contingency stock, IVRS parameters and requirements of drug product. Where possible seek innovative flexible supply chain solutions capable of supporting multiple studies.
Using this information, develop options for how the supply requirements of individual/groups of clinical studies can be delivered and propose to the Supply Chain Team. This will include sourcing (in or out) and alignment of sourcing activities with customers, detailed plans including timing of investments/cost expenditure (e.g. purchase of comparator product, phased spend at CROs), identification and management of risks.
Produce a Study Drug Packaging Agreement documenting the agreed supply option providing details of the design, set-up and how the supply chain will operate for each study/group of studies.
Ensure SC input into the design of the random scheme, incl. pack lists and timely provision of these to Delivery or CRO
Define IVRS user requirements, set up IVRS tool and ensure timely go-live for individual studies. Use IVRS to track recruitment and adjust IVRS parameters to accommodate any changes in study scope and design.
Collaborate with CRO partners in development of pack design and review the technical part of the outsourcing contract. Review changes to the contract with CRO partners and Sourcing Managers as necessary.
Establish the supply chain for individual/groups of studies and ensure delivery of the end to end supply of materials to meet study needs
Monitor the performance of the supply chain and optimise for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk.
Monitor the budget for individual study supply activities and materials for the project. Flag deviations to SC Programme Manager
Maintain appropriate information for study supply activities to support updates in OPAL.
Manage change in demand and supply, resolve issues, escalating when appropriate
Work with other Study Managers to resolve issues, share best practice and continually develop competence.
Promote supply chain practice in Pharm Dev and interfacing functions.
Where appropriate deputise for SC Programme Manager on SCT and PD Project Team.
Represent RD SC at monitors / investigators meetings and share learning within AZ.



Minimum Requirements
* Degree in supply chain related or drug development discipline or equivalent qualification or experience.
* Extensive experience working in supply chains  (5+ years preferred)
* Significant experience managing and influencing customer demands
* Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products In depth knowledge of RD supply chain and drug development process
* In depth knowledge of Clinical Development processes relevant to the supply of clinical materials
* Experience of project management
Skills and Capabilities
* Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries.
* Demonstrated technical skills and mindset in supply chain management including demand management, supply chain design / optimisation and delivery.
* Track record of good project management
* Risk identification and management
* Excellent written and verbal communication skills.
Leadership Capabilities
Strategic Leadership: Clarifies Complexity: Thinks more broadly than their role (e.g. externally) and uses this in sight to challenge and adapt current approaches in one's area in an effort to simplify complexity and/or ensure alignment.
Acts Decisively: Takes Calculated Risk: Makes effective decisions despite uncertainty and or incomplete information to drive business outcomes Communicates clearly to ensure alignment and empowers others with decision-making authority as appropriate.
Drives Accountability: Holds Others Accountable: Communicates clear expectations of behaviour and outcomes as well as why these standards matter. Hold others to account for delivering them.
Works Collaboratively: Encourages Diverse Thinking: Creates an environment in which diverse viewpoints are sought and encouraged, both within and beyond the team (e.g. with external partners).
Develops People and Organisation: Provides Developmental Feedback: Has an objective view of others' capability and provides timely feedback and coaching to support other's growth and enhance performance
For this role, the target level for all leadership capabilities is 2.
Core Capabilities
Business Relationship Management
Flexibility/Adaptability
Influencing
For this role, the target level for all core capabilities is Competent
Internal and External Contacts/Customers
* RD Supply Chain functions
* Other Pharm Dev functions - PPM, QSP
* Clinical; Study Delivery, Biostatistics, CPA
* Operations, RD Procurement
* CROs and other external supply / service providers
* Relevant functions in Medimmune.
Reporting Relationships
 Direct Reports: None
 Indirect Reports: SDWG members
Budget responsibility
Indirect responsibility and monitoring: up to $5 million per programme
Measure of Success
* Interpret and influence clinical demand and use supply chain expertise to design effective supply chains balancing cost and risk to supply.
* Delivery of product to meet customer requirements to time, within budget and to appropriate quality standards
* Lead time, costs and waste less than or equal to target
* Good feedback from SCT and Project Team members on leadership capabilities, behaviours and delivery.
* Role will have multiple contacts across internal and external groups; success will be judged by abilit Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation


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