Clinical Study Supply Lead

As a
CLINICAL STUDY SUPPLY LEAD IN GLOBAL CLINICAL SUPPLY CHAIN (PART OF CLINICAL MANUFACTURING AND SUPPLY) YOU’LL DEVELOP A BROAD KNOWLEDGE OF THE DIVERSE RANGE OF CLINICAL STUDY OPTIONS UTILISED BY THE PHARMACEUTICAL INDUSTRY, AS WELL AS IN-DEPTH EXPERTISE IN SPECIFIC THERAPEUTIC AREAS. WE’LL LOOK TO YOU TO DESIGN, PLAN AND MANAGE TRIAL MEDICATION FOR PATIENTS TAKING PART IN ASTRAZENECA CLINICAL STUDIES ALL OVER THE WORLD. IN RETURN, YOU’LL FIND A VIBRANT TEAM CULTURE IN WHICH CONTINUOUS IMPROVEMENT AND EFFECTIVE COLLABORATION ARE HIGH PRIORITIES.

DO YOU HAVE LEADERSHIPS SKILL AND ENJOY CHALLENGES? DO YOU WANT TO TAKE YOUR SKILLS AND EXPERIENCE TO A NEW LEVEL IN THE PHARMACEUTICAL INDUSTRY? WE ARE LOOKING FOR A CLINICAL STUDY SUPPLY LEAD, YOU WILL WORK IN CLOSE COLLABORATION WITH CUSTOMER FUNCTIONS TO INFLUENCE &AMP MANAGE DEMAND FOR CLINICAL TRIAL STUDIESAND BE RESPONSIBLE FOR THE SUPPLY CHAIN DELIVERABLES

AS A CLINICAL STUDY SUPPLY LEAD you will be:
Part of the Global Clinical Supply Chain organisation.
Lead a cross functional team to deliver supply to clinical studies across the world
Work closely with both internal and external suppliers
Be part of the Supply Chain Team



MAIN RESPONSIBILITIES:
Lead and provide direction to Study Drug Working Groups, consisting of members of Clinical Manufacturing and Supply, Clinical Development and external partners.

Ensure the team delivers clinical supplies effectively and consistently, balancing cost and risk to supply with expert input and support from cross functional groups.

Understand and translate clinical study protocol requirements into demand for drug product within a clinical study.  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 and ensure delivery of the end to end supply of materials to meet study needs.  Define IRT user requirements and use IRT to track recruitment and adjust IRT 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.

Monitor the budget for individual study supply activities and materials for the project. Manage change in demand and supply, resolve issues, escalating when appropriate.

Work within GMP Quality Management Systems, including managing deviations, complaints, change controls as appropriate.

REQUIREMENTS:
Relevant academic degree
Knowledge of Clinical supply
Documented strong leadership.
Willingness to drive change in the Supply Chain activities in a manufacturing environment
Experience from a manufacturing organization or previous working knowledge of Lean is highly desirable
Excellent communication skills in both Swedish and English, both verbally and in writing
Experience in drug development discipline. e.g. Pharmacist
Knowledge of Clinical Development processes relevant to the supply of clinical materials is meritorious
Strong influencing, negotiating and problem-solving skills, including across functional, geographical and cultural boundaries is meritorious

 

VALUES AND BEHAVIOURS:
We are Entrepreneurial:
-  I collaborate with colleagues internally and externally to seize opportunities and make decisions with speed.

We do the Right Thing:
- I take personal accountability for my actions and for the success of AZ as a whole.
- I treat colleagues with respect and candor

We put Patients First:
- I hold myself and others accountable for making decisions in the best interests of the patient.