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Patient Supply Compliance Manager - 12 Month FTC

achilles-therapeutics · 20 days ago
Negotiable
Full-time
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Achilles Therapeutics is a high growth clinical-stage biopharmaceutical company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. Originating from pioneering research at Cancer Research UK (CRUK), the Francis Crick Institute and University College London (UCL), we use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient. From this, we develop personalised T cell therapies and currently have two programs in the clinic for the treatment of Non-Small Cell Lung Cancer and Metastatic Malignant Melanoma.

As a company, we are fast-paced and trailblazing. We are breaking new ground with our science, creating products that have never been made. As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organisation, working together to solve novel problems. This entrepreneurial spirit and approach run through our company and those who thrive here are able to cope with anything that is thrown at them, enjoy ambiguity and thrive on making things happen even when there is not a detailed brief. We work hard and deliver a lot.

Primary Duties

  • Oversight and management of patient supply chain compliance for the business  
  • Carry out audits against HTA standards 
  • Manage the supply chain set-up of clinical sites in all regions globally  
  • Oversight of onboarding and vendor management  
  • Ensure compliance of the end-to-end ATIMP supply chain to all regulatory standards, inc. HTA, GCP, etc 

Responsibilities/ Accountabilities

  • HTA Persons Designate and liaise directly with the HTA as required 
  • Carry out compliance activities to ensure the business is compliant regarding the end-to-end patient supply and HTA regulations  
  • Perform internal audits and provide support for inspections 
  • Participate in the resolution of corrective and preventative action plans 
  • Prepare/present data in support of PSO and HTA activities 
  • Monitor HTA related regulatory changes/updates; advise on compliance 
  • Manage the supply chain set-up of new clinical sites, and onboard sites from a supply chain perspective   
  • Oversee end-to-end traceability for all HTA-regulated patient samples in Achilles trials  
  • Ensure compliance with ongoing supply chain operations. Timely input and completions of assigned tasks as per change controls/deviations/risk assessments etc.  
  • Act as point of contact for internal functions/external vendors that have touchpoints to HTA activities  
  • Manage HTA-related SOPs and internal training requirements 
  • Perform trending activities to support PSO and HTA compliance monitoring 
  • Provides support/oversight for other governance activities i.e. JACIE/FACT/UKAS/GCP etc.    
  • Vendor Management  
  • Responsible for ensuring up to date filing of eTMF documents 

Requirements

Experience/ Skills

  • Demonstratable experience of working with Human Tissue Act regulations
  • Demonstratable experience of working in Clinical Research or the Pharmaceutical Industry
  • Bachelor’s degree (BSc, BA or RN equivalent) in biological or science-related field preferred
  • Good knowledge of the Clinical trial process
  • Good knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice guidelines (ICH-GCP)
  • Self-motivated taking personal pride in delivering on personal and corporate objectives
  • Able to interact with individuals at all levels of the organisation
  • A highly effective communicator, both orally and in writing with an eye for detail and accuracy
  • Strong organisational, time management and communication skills
  • Ability to act on own initiative within inter-related teams and meet deadlines and dynamic turnaround requirements
  • Microsoft Office Skills -excellent proficiency in Word, Excel, PowerPoint and Outlook required

Benefits

This is a permanent role, offering a competitive benefits package

At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership, and teamwork. We work hard and deliver a lot

Our benefits package includes a competitive salary and performance related bonus, group pension plan matched up to 6%, life insurance, private medical insurance, and a tax approved all employee share incentive plan.

Last updated on May 28, 2024

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