Clinical Supply Lead

JOB DESCRIPTION

Department:  Clinical operations                            

Reports to:  Chief Medical Officer (in future reporting to Senior Director Clinical Operations)                                                           

MAIN PURPOSE OF JOB                                                                                                                         

The Clinical Supply Lead is responsible for the strategic planning and execution of the clinical trial supply chain and the co-ordination of translational supply, for example tox studies. This involves the ability to interpret a clinical trial protocol in conjunction with other key study information to create an appropriate kit design and formulate a strong supply plan. The Clinical Supply Chain Lead will be responsible for collaborating with internal and external partners, to ensure delivery of the supply plan in accordance with study timelines.

KEY ACCOUNTABILITIES

• Lead the creation of the policies, processes and procedures for clinical supply.

• Interpret clinical trial protocols to create and execute an effective clinical trial supply chain solution and create English master label text in accordance with relevant regulatory framework and QP guidelines to co-ordinate and ensure on-time and compliant completion of clinical trial deliverables, including: IMP packaging labelling and distribution.

• Create and maintain demand forecasts and packaging plans, and initiate packaging campaigns so that packed clinical supplies are readily available in accordance with the project requirements, having accountability for the overall timely delivery of quality clinical supplies.

• Interpret relevant study data to ensure supply chain is maintained.  Setup, monitor, and where necessary, update study assigned Interactive Response Technology (IRT) systems to ensure study inventory is effectively managed.

• Create an appropriate distribution plan and have oversight of the assigned vendors, building a trusted partnership relationship

• Ability to work independently and proactively to ensure that the supply of all trial materials are delivered to the right place at the right time and in the correct condition.

• Remain up to date in all GxP and regulatory requirements applicable to the role, facilitating internal stakeholder and external vendor related meetings where necessary to discuss clinical supply chain topics or status updates

• Create a temperature excursion management plan responsible for the review and assessment process of Temperature Excursions and undertake regular risk management assessments to ensure all risks are systematically reviewed and appropriate mitigation is in place

PERSON SPECIFICATION

• Expert knowledge of GMP, GLP, GDP and ICH guidelines and their application to support the supply of clinical trials.
• Experienced and knowledgeable in regulatory requirements for clincial supply of studies in multiple jurisdictions.
• The candidate will be confident in their ability to represent clinical operations and leading cross-departmental coordinated efforts whilst working as an individual contributor, internally managing projects to ensure on-time delivery and also working with vendors.   
• Bachelor’s Degree (or equivalent) – with minimum 3 years’ experience working in Clinical Operations -or- Clinical Supplies.
• Ability to work independently with strong organizational, project management and analytical skills 
• Experience of managing an outsourced supply chain function
• Ideally experience of working within a Biotech environment

KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF

People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.

Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.

Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.

Candid and Constructive – We communicate with honesty and transparency throughout the team.  We value giving and receiving constructive feedback to each other and our partners.