Associate Director, Study Supply Management
Location: Barcelona, Spain (On-site): We requiere 3 days working from the office and 2 days working from home.
Join our Biopharmaceuticals R&D team as an Associate Director, Study Management. In this role, you will provide oversight for Study Supply Management activities, ensuring delivery across a breadth of supply functions within the LCS (Logistics and Clinical Supply) matrix. You will independently plan, handle and deliver all aspects of Investigational Medicinal Product (IMP) supply from protocol concept to study completion for assigned clinical studies. This is an opportunity to work with curious minds in an inclusive culture where all doors are open, and every voice is heard.
Typical Accountabilities:
- Provide general oversight for Study Management activities within LCS ensuring highly effective planning and management of IMP supply for clinical studies.
- Play an active role in technical management of LCS Study Managers, including technical direction / support and input to definition of robust Study Manager assignments.
- Where necessary ensure project continuity through key transition events and staff absences
- As required provide direct oversight and supervision to specified studies led by other members of the Study Management group
- Independently plan, manage and deliver IMP supply for assigned clinical studies. An Associate Director, Study Management will typically have direct responsibility for management of multiple studies involving diverse development compounds and/or external collaboration based studies as required. Studies may be domestic and /or international in scope and will include complex operations such as associated with later phase clinical trials, or in provision of Auxiliary Medicinal Products (AMP)
- Influence, own and promote functional deployment of tools and procedures to catalogue required to support IMP supply activities
- Ensure that Study Manager input into study related documents and activities is relevant, accurate and timely.
- Provide oversight of the activities related to processing of product complaints, non-conformances, product recalls or enquiries pertaining to assigned clinical studies
- Throughout each project lifecycle, promote and ensure maintenance of current, accurate and complete IMP related study documentation (hard copy and electronic as appropriate). Enable that all vital files are uploaded in a timely manner to the Trial Master File (TMF), appended to the Product Specification File (PSF), or made available within other relevant GXP system as required.
- Maintain and expand close cross-functional relationships while proactively seeking information pertaining to clinical studies to best design, plan and implement Study Management activities for all relevant projects
- Collaborate within LCS to ensure highly effective matrix working including closely coordinated delivery of Study, Vendor, Distribution and Systems management activities for each relevant study.
- Ensure representation of all matrix functions (Study, Vendor, Distribution and Systems management) at the Supply Continuity Team (SCT).
- As a member of the SCT supply to and influence the development /supply strategy, ensuring that the demand, risks and opportunities for supply optimization are discussed
- Enable creation, maintenance, and clear communication of supply strategy and aligned dynamic long range project demand forecast for assigned clinical studies.
- Liaise closely to ensure clear transfer of information to the Vendor group responsible for management of the study budget
- Represent LCS as an engaged and active participant at the Clinical Trial Team (CTT). Ensure clear information exchange in relation to current supply activities and influence for effective and timely consideration of any change scenarios that may impact supply plans. Provide dynamic talk to the SCT to ensure on-going responsiveness to any factors that may impact supply strategy, aligning planning and implementation of any agreed changes
- Liaise closely with Quality Assurance (QA) to ensure that all Study Management activities are conducted in accordance with cGMP, GCP, & ICH guidelines
- Initiate non-conformances when identified and complete investigations to support on time closure of Trackwise records
- Partner with stakeholder departments (e.g. Quality Assurance, Analytical, clinical and Regulatory) to develop, communicate and deliver a risk mitigated supply strategy. Ensure that any issues relating to IMP release and supply to the clinic are highlighted and that solutions are provided for the project and for other similar projects in Development.
- Influence and enable development of optimal working practices, SOPs, systems and tools, to ensure robust Study Management execution and partner communications.
- Apply skills and knowledge to advise and/or develop improvements and future growth opportunities ensuring that LCS Study Management working practices are well aligned to business requirements
- Support analysis and advise on development of Study Management scope and activities to improve efficiency and enable robust interfaces and/or execution
- Lead departmental process improvement initiatives as required
- Actively engage in the creation and maintenance of LCS department SOPs and aligned guidance documents or other work instructions and training materials. Ensure procedures are
- maintained as accurate, enterprise aligned (where required) and reflective of current standard process.
- As a member of the LCS Senior Management team, play an active role in operational management of the group, including deputizing for other managers as required
- Represent LCS in cross functional initiatives of moderate business impact, such as would benefit the design and establishment of organizational processes
- Apply own unique training and expertise to deliver against flexible assignments within other LCS roles
- Mentor, develop and supervise the daily activities of LCS staff acting either as Technical Manager or in relation to matrix team members. Enable through others highly effective Study Management, team working and overall supply strategy and delivery
- As required act as Line Manager for LCS staff enabling delivery through direct reports and advancing employee engagement and development
- Communicate seamlessly within assigned teams, and with all interfacing functions and relevant groups as required.
Typical Accountabilities (per AZ framework and regulatory expectations):
- Accountable for the delivery of clinical study supplies on time and on budget
- Agrees study supply plans including activities, resources, costs, roles, responsibilities and quality assurance.
- Delivers work plans and recommends revisions as appropriate to meet changing needs and requirements. Ensures that impact and changes are effectively communicated to the business
- Undertakes and promotes accurate reporting and data management via both information systems and paper-based systems
- Maintains relationships with key business stakeholders to ensure business requirements are effectively assembled and committed to project objectives
- Optimises performance outcomes of cross functional teams and ensures individuals understand the contribution they make
- Acts as point of contact to third party suppliers providing services to AZ – chiefly manufacturing suppliers.
- Builds and leads study matrix teams, communicating roles and responsibilities whilst encouraging partnership and collaboration amongst the team and business collaborators
- Monitors and maintains compliance to current current cGMP, GDP, GCP, & ICH guidelines, raising and addressing problems as they arise
- Develops and follows policies and procedures in execution of activities. Promotes continuous improvement, identifying and delivering performance improvements
- Communicates and aligns to ensure appropriate quality service delivery and appropriately brings up within the Study Management funtion where issues threaten delivery
Education, Qualifications, Skills and Experience
Essential:
- Bachelors degree in basic/applied science or engingeering. Equivalent level of training in service may be considered
- Stakeholder management in a customer facing role. Demonstrates tact and diplomacy in building/ managing relationship and partners to achieve objectives
- Direct Experience in a Development or Technical Opearations environment in the pharmaceutical, scientific or health care industry.
- Specific experience in delivery of international clinical studies, with focus on IMP supply & management
- An excellent understanding of cGMP, GCP and ICH guidelines as related to IMP management, and a sound understanding of the drug development process
- Experience of development and working application of policies, procedures and guidelines
- Ability to work in a dynamic environment, and collaborate effectively within cross functional teams to deliver complex projects
- A high level of commitment, flexibility, initiative and independence, with strong skills for planning, coordination, teamwork, communication and interpersonal relations
- Strong analytical skills, excellent attention to detail and interest in technical troubleshooting.
- Highly organised teamworker with IT proficiency appropriate to a systems driven manufacturing role
Desirable:
- May have higher level academic qualification (e.g. Masters)
- Professional qualifications
- Change responsive
- Influencing and negotiation skills.
- Experience managing people (either as line or matrix manager) - can coach, train and promote positive morale amongst their teams
- Substantial experience in planning and delivering all aspects of IMP management for complex clinical studies, including oversight of vendors performing GMP operations
- Experience of working in a global organisation with complex geographical context
- Experience of managing ambiguity whilst navigating through it
At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before.
Are you ready to join a team unlocking the power of what science can do? Apply now to be part of our journey towards creating life-changing medicines!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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