Senior Project Manager (Sr. CPM) - Clinical Operations
Achilles Therapeutics, United Kingdom
Job Description
Role Summary
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.
Key Responsibilities
Play a pivotal role as an early hire in our Supply chain to support our MAP platform (Material Acquisition Platform) which is an important source of samples supporting our innovative programmes across Ramp;D and GMP through our lead indications and new indication plans. The Sr. PM will lead a team of PM/ junior PM supporting ongoing and new indications within this platform, working to manage the MAP program globally. Working in conjunction with the Supply Chain Manager, clinical operations, Translational Science, Quality Assurance, etc.
You will play a key role in this operation and serve as a team lead to other junior members of the team. Act as an expert in the research or preclinical with Cell therapy, TILs experience is preferable. You must be able to work independently and part of the team, some of which may be remote.
This position will have key relationships with internal stakeholders and will have clearly defined responsibilities working alongside the Head of the supply chain, as well as externally with site staff, KOL, Surgeons, Study Coordinators, and some vendors.
- Lead the overall initiation, coordination, implementation and management of international clinical trials from start-up to closeout.
- Lead the cross-functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met.
- Manage operational and technical aspects of projects including budgeting, study initiation and risk management.
- Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation.
- Select, manage and coordinate external vendors
- Monitor vendor performance and ensure continuous oversight.
- Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required.
- Represent clinical operations on multi-function project teams internally and externally; report on study progress.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans.
- Ensure the delivery of the clinical study according to ICH GCP, local applicable regulations and company’s specific SOPs.
- Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study-related documents.
- Design, review and approve of all trial-related documentation, and establish trial processes.
- Provide support to the team for EDC and eTMF
- Develop or review and support SOP development or update.
Requirements
- Minimum of 10+ years clinical trial experience with minimum of 8 years’ experience in project management and 3 years leading a team
- Strong project management experience in cell therapy and/or advanced therapy.
- Previous experience of site monitoring in early phase oncology studies ideally in melanoma or NSCLC, Head and Neck, Lung, Renal and Bladder
- Excellent collaboration and communication skills.
- Adept at partnering with a diverse team and delivering results through taking ownership of key programme components.
- Strong clinical, technical or disease area expertise.
- ICH GCP trained.
- Early phase clinical trials and research study management is a plus
- Must be able to utilize management systems to track milestone, prioritize and multitask
- Willingness to work on-site full-time