LIFE AT Achilles

At Achilles, we are focused on the development of the next generation of personalised immunotherapies to treat cancer and are dedicated to our patients, who desperately need breakthrough medicines.

We provide extraordinary career opportunities for talented individuals, who will have the opportunity to work with highly experienced leaders in science and business to build an exciting company at the very cutting edge of cancer medicine.

At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership and teamwork. We offer benefits that include competitive salary and performance related bonus, group pension plan, life assurance, private medical insurance and employee share incentive scheme.

If you have what it takes to help build Achilles into a world class immune-oncology company and would like to become a part of our team, please contact: jobs@achillestx.com.

Achilles is an equal opportunity employer committed to a culturally diverse team.

Recruiters and agents must not forward CVs or candidate details to Achilles or any employee of the Company without an explicit, written request from a member of the HR department. We reserve the right to pursue and hire candidate(s) without any financial obligation to the recruiter if their details, which could reasonably identify them, have been passed to the Company without the explicit, written request of a member of the HR department. The agreement of terms in relation to a specific vacancy does not constitute an explicit request for applicants for other advertised roles or speculative applications.

What Our Team Say

I was attracted to Achilles by the ambition of the science that underlies Achilles’ goal. I enjoy the fast-paced environment of a start-up, encountering new challenges on a daily basis. Achilles has a multicultural and cohesive culture with a very strong sense of purpose.

Eleni Kotsiou

Principal Scientist, Process Development

I joined Achilles because I am interested in developing a cancer immunotherapy product with the aim of taking it to clinic. I really enjoy working within a multidisciplinary team and the variety in my role across process development and manufacturing.

Sam Jide-Banwo

GMP Production Scientist

Open PositionsAt Achilles

Research Scientist, Product Characterisation

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Summary:
We are seeking a bright, motivated and highly organised scientist with experience in immunological laboratory techniques, to join our growing company and support the development of a next generation personalised cancer medicine.

As a Senior Scientist at Achilles Therapeutics, you will report directly to a Principal Scientist within the Process Development team and support the team’s efforts to further optimise and develop different immune assays. You will also work closely with members of the Translational Science and Manufacturing teams to carry out and organise assays on human samples from clinical trials at Achilles Therapeutics at the Stevenage site.

If you want to be a part of a well-funded, exciting new start-up, and enjoy contributing to development of products which will transform the clinical management of cancer, then this is the role for you.

Responsibilities:

  • Coordinate characterisation and analysis of Achilles’ clinical trial products
  • Carry out immunoassays including multi-parameter flow cytometry and ELISpot on clinical trial and Process Development samples
  • Support the setting up of the Translational Science team at Stevenage
  • Design and optimise assays that characterise Achilles’ cNeT product
  • Complete all relevant documentation in accordance with GCLP guidelines
  • Design new SOPs and worksheets and follow established SOPs
  • Receive and process cryopreserved samples

Essential experience:

  • PhD in immunology
  • Laboratory experience post PhD
  • Practical experience in human primary T cell culture
  • Practical experience with immunoassays including multi-parameter flow cytometry
  • Writing and reviewing of SOPs
  • Assay optimisation
  • Excellent planning, organisational and time management skills, and attention to detail
  • Team Player: Ability to learn from senior and junior members of the team
  • Good communication and interpersonal skills
  • Self-motivated with strong initiative and drive
  • Ability to work flexibly including evenings and weekends, as required
  • Proficiency with MS Office

Desirable experience:

  • Experience working in a GCLP (or GxP) laboratory
  • Practical experience in ELISpot assay
  • Practical experience in Fluorospot
  • TCR repertoire analysis
  • Assay qualification and validation experience
  • Writing and reviewing SOPs to GCLP standard
  • Practical experience of working with and/or set up of a LIMS system
  • Working knowledge of HTA

This is a permanent position, based in Stevenage, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

 

Engineering Project Manager

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Summary:
We are seeking an ambitious and engaging Engineering Project Manager to lead and manage large GMP capex projects from concept design through to construction, commissioning and validation.

You will have the opportunity to act as the Achilles point of contact with external Project Management companies and drive the deliverables to ensure on time completion.

This role offers significant visibility with our Leadership teams and is a key and critical hire in the organisational expansion.

This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:

  • Provide regular reports and updates to senior management and any relevant Achilles group meetings
  • Be accountable for establishing project plans and timelines for the GMP capex project
  • Serve as the primary point of contact with external collaborators and consultants for the delivery of the project including representing the company at build team project meetings
  • Arrange external and internal meetings, prepare meeting agendas, keep detailed minutes and ensure decisions are actioned
  • Document and track operational deliverables for commercial manufacturing projects

This position requires:

  • Degree in a relevant engineering discipline or equivalent
  • Project management qualification
  • Experience of delivering engineering/capex projects in a GMP environment in life sciences, preferably from concept design through to construction, commissioning and validation
  • Experience of working in cell and gene therapy
  • Excellent interpersonal and organisation skills
  • Ability to work under pressure, prioritise and operate in a fast-paced environment

This is a permanent position, based in London, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Software Tester

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a talented and enthusiastic Software Tester to support the verification and validation of our bioinformatics software pipeline in a full-time position. This software is a highly specialised pipeline focused on the identification of neo-antigens from exome-level sequence data to direct the development of targeted immunotherapies in cancer.

The successful applicant will be expected to possess a strong knowledge and experience of testing and its best practices. You will understand the appropriate levels to test at and be able to write and execute high quality tests. Your responsibilities will include preparation of test data, designing and executing tests and working closely with the development team.

This position requires:
• Bachelor’s degree in computing science or equivalent experience
• Prior experience of working as a software tester
• Experience writing in at least one automated test framework (e.g. testthat, pytest, Junit)
• Experience writing Python/R/Groovy scripts
• Ability and eagerness to rapidly learn new languages/frameworks as required.
• Experience working in a Linux command-line environment
• Experience with Git version control

In addition to the above, the following skills/experiences are desirable:
• Experience with Continuous Integration
• Strong knowledge of Groovy/Java, Bash
• Experience working with HPC/AWS and Docker
• Bioinformatics experience
• Experience working with the Atlassian toolchain (Jira, Bitbucket, Confluence)
• Experience working in an Agile/Scrum environment

Successful candidates will also possess good communication skills, a desire to work in a dynamic fast paced team environment and an ability to manage multiple, concurrent initiatives. Prior bioinformatics experience is not required, but a willingness to learn is essential.

This is a unique opportunity to work with a leading team of scientists with an international reputation for excellence in immuno-oncology research and to become a key contributor to an exciting project destined to change the course of cancer patient management in the clinic.

This is a permanent position, based in Stevenage, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Principle Scientist

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Summary:
We are seeking a Senior/Principal Scientist (appointment level dependent on skills and experience) to work within our Translational Science team and join our growing company to support the development of a next generation personalised cancer medicine. As Senior/Principal Scientist at Achilles Therapeutics, you will work as part of the Translational Science team to oversee external vendor activities and set-up of new internal laboratories at existing and new sites for Achilles Therapeutics. You would also be expected to work closely with other members of the team to carry out immune monitoring assays for follow-up of clinical trial patients.

The successful candidate will manage existing relationships with external vendors performing work within the scope of our Translational Science programme, and lead on selection and qualification of new vendors, including planned expansion to the US. They will oversee set-up of new Translational Science Laboratories at Achilles expansion sites, including managing change control and qualification and validation (Q&V) of new facilities and equipment. As part of the Translational Science team, it will also be necessary to be trained in immune monitoring assays to provide lab support for the team, as required.

The ideal candidate will have experience in selecting and managing external vendors, including vendor qualification to GxP requirements. Knowledge of quality assurance procedures is essential, while experience of working in a Good Clinical Laboratory Practice (GCLP) laboratory or in accordance with GCLP guidelines is of benefit. If you want to be a part of a well-funded, exciting new start-up and enjoy contributing to development of products which will transform the clinical management of cancer, then this is the role for you.

This position requires:

  • Oversee vendor selection and qualification including participating in vendor audits.
  • Oversee data transfer from vendors to the Translational Science analysis team.
  • Liaise with other Achilles members of staff to set up new Translational Science laboratories according to GCLP guidelines.
  • Prepare documentation, including Change Controls and Q&V documents, according to GCLP and Achilles QMS guidelines.
  • Oversee validation and maintenance of laboratory equipment.
  • Carry out immune monitoring assays to support the Translational Science labs team.
  • Supervise junior members of the Translational Science team.

In addition to the above, the following skills/experiences are desirable:

  • Undergraduate degree in a biological subject
  • Hands-on laboratory experience
  • Experience working in a GCLP laboratory or according to GCLP guidelines
  • Experience managing external vendors
  • Proficiency with MS Office
  • Excellent planning and organisational and time management skills
  • Good communication and interpersonal skills
  • Self-motivated with strong initiative and drive

Desirable experience:

  • Master’s/Postgraduate degree in a relevant subject
  • Knowledge of cancer biology and immunology
  • An understanding of Human Tissue Authority legislation
  • Experience working with a LIMS system
  • Immunoassay experience eg ELISPOT

This is a permanent position based across Achilles Sites in Stevenage and London, with a competitive salary and benefits package to match seniority and experience. The company has laboratories in London and Stevenage UK.

Please send your CV with a covering letter by clicking Apply.

 

QC Scientist

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a bright, enthusiastic and motivated QC scientist, ideally with experience in the a GCLP (good clinical laboratory practice) environment to join our growing multi-disciplinary team and support the development of a next generation personalised cancer medicines.
As a QC scientist you will support the validation and clinical production of Achilles Therapeutics ATMP pipeline at the Royal Free Hospital or Stevenage and work closely with the GMP manufacturing team and product development team to support process engineering activities. If you want to be a part of a well-funded, exciting new start-up, and enjoy playing an active role in supporting the development and clinical manufacture of ATMPs which have the ability to transform the clinical management of cancer, then this is the role for you.

Responsibilities:
• Carrying out QC testing of raw materials, in process controls, and finished product, in line with GMP regulations.
• To assist in the preparation and review of documentation including SOPs and risk assessments to ensure the highest levels of controls and traceability.
• Perform immune monitoring for clinical trials and ensure all activities are undertaken in accordance with GCLP and quality standards.
• Assist in the design and validation of immune monitoring assays using flow cytometry and ELISpot.
• Perform maintenance and calibration of laboratory equipment including flow cytometers.
• To coordinate activities with manufacturing to ensure appropriate and timely sampling and testing of raw materials, in-process samples and finished product.
• Be accountable to the Principal QC Scientist.

Education and Experience:
• MSC in a Biological Science discipline.
• 3 years’ experience in a scientific laboratory role.
• Experience working in a GLP/GCLP regulated environment.
• Experience in human cell isolation, and cell and tissue culture.
• Experience in flow cytometry and ELISpot.
• Experience in assay validation.
• Understanding of GCLP guidelines.
• Strongly focused on quality and safety.
• Have excellent planning and organisational and time management skills.
• Have good communication and interpersonal skills.
• Self-motivated with strong initiative and drive.

This is a permanent position based in London or Stevenage, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Computational Biologist

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a highly talented and creative Computational Biologist. The successful applicant will join a small team primarily focused on improving and developing methods to identify neoantigens. You will be expected to proficiently identify and benchmark published tools as well as contribute to the development of novel strategies. You will also design, implement, and apply statistical techniques to analyse and integrate large datasets and work in close collaboration with biologists and clinicians to interpret your analysis results.
In this role, you will have ownership and responsibility for leading large-scale projects focused on delivering creative solutions to challenges across the business. You will have the opportunity to work with creative freedom and utilise innovative technologies.
This is a unique opportunity to work with a leading team of scientists with an international reputation for excellence in immuno-oncology research and to become a key contributor to an exciting project destined to change the course of cancer patient management in the clinic.

Responsibilities:
• Integration and exploratory data analysis of large, complex datasets
• Develop and test hypotheses whilst prototyping analytical approaches/models
• Develop scalable tools
• Effectively communicate analyses to a technical and non-technical audience

Personality Profile:
• Drive
• Resilience
• Creativity
• Ownership

This position requires (Essential):
• PhD
• Experience in bioinformatics, computational biology, or equivalent
• Demonstrated fluency in R and Python
• Experience of advanced statistical modelling
• Experience of Machine learning concepts
• Good knowledge of molecular genomics and immunology

Preferred experiences:
• Practical experience of analysing next generation sequencing data (DNA and RNA)
• Authorship on high-quality papers in peer-reviewed journals
• Experience in reproducible research practices (e.g. dynamic documents, version control, containerization & workflow engines)
• Extensive knowledge of UNIX based operating systems
• Practical experience of oncogenomic, immunogenomic, neoantigen and/or TCR-seq analyses
• Practical experience with cloud-based technologies

This is a permanent position, based in London, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Biostatistician

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role Summary:
Achilles Therapeutics is looking for an ambitious and skilled Biostatistician to join our Translational Science team. This team is responsible for the development and delivery of analyses that turn exploratory hypotheses into actionable insights from our clinical trials.
The Biostatistics role at Achilles will be pivotal for delivering robust statistical analyses to evaluate exploratory hypotheses in our Translational Science program.
This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:
• Work within the multidisciplinary Translational Science team and forge strong links with other teams at Achilles to facilitate best practice for the analysis of our biological datasets.
• Model and integrate biological datasets from a variety of sources (e.g. NGS, proteomics and Flow Cytometry) to evaluate our existing hypotheses and guide the future direction of the Translational project.

This position requires:
• Recent PhD (or MSc and 2+ years of relevant work experience) in Biostatistics, or Bioinformatics with a high component of statistical training
• Demonstratable experience in handling, modelling and drawing inferences from large volumes of biological datasets
• Authorship on high-quality papers in peer-reviewed journals
• Demonstrated fluency in either R or Python
• Knowledge of UNIX based operating systems and prior use of cloud computing resources
• Very strong communication skills in order to convey statistical analyses
• Exceptional time management agility to manage concurrent projects
• A clear ability to develop robust data analyses to fixed timescales

This is a permanent position, based in London, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

Head of Clinical Operations US

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and melanoma expected to enter the clinic in 1H 2020.

Role Summary:
We are seeking a Head of Clinical Operations to establish and build operations through North America. The Head of Clinical Operations (US) is responsible for the delivery of the clinical development program (initially two studies with scope to build out further studies) to agreed budget timelines and quality metrics. The person will also lead data management activities across programs to ensure that clinical outputs are of consistently high quality.

Responsibilities:
• Work closely with the VP, Clinical Operations and Director Clinical Operations EU.
• Responsible for the delivery of the clinical development program initially two studies with scope to build out further studies
• Lead data management activities across programs to ensure that clinical outputs are of consistently high quality
• Ensure compliance in all aspects of tissue procurement shipment and storage and ATIMP management and delivery for clinical trials in North America
• Direct line management accountabilities to build a team including clinical project managers, CRAs and CTAs, and will ensure adherence to established guidelines, standards and SOPs. The Head of Clinical Operations will ensure that individual clinical projects are adequately resourced in conjunction with the VP, clinical operations
• A senior member of the Clinical Operations Team
• Ensure adherence to GCP and other rules/regulations as appropriate
• Ensure Vendor contracts are “workable” and accurate. Ensure in-house tracking systems
• Work with a Quality manager (consultant or in-house) to ensure SOPs, forms & templates are ready and current for clinical use
• Support CPMs for processes of Site level approvals /Ethics/MHRA submission and maintenance (UK and EU)
• CT management plans – ensure current and fit for purpose
• Performing Site initiations (where required), overseeing clinical trial and escalation point for vendors by CPM
• Oversee the process of Serious Adverse Events, ensuring medical review and reporting requirements are met
• Vendor assessment and selection in conjunction with VP Clinical Ops
• Oversee and ensure contract process for vendors and study sites, supporting the CPM for the indication
• Co-ordinate and lead CPMs for preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements.

This position requires:
• Knowledge and/or experience with cellular therapies preferred
• Science, medical or pharmacy degree in relevant discipline at BSc level or higher
• At least five years of experience in clinical trial management, preferably in a biotechnology environment
• Experience with cellular therapy, individualized therapy, and/or ATMPs (desirable)
• Experience working in Oncology trials
• Proven experience in clinical trial management in a relevant organisation
• Demonstrated ability to manage early phase clinical trials
• Experienced in working with a CRO, and being responsible for oversight, support on routine events to the CPM in tasks assigned to the CRO
• Judgement and problem-solving abilities to identify solutions to routine issues and seek guidance on more complex issues
• Strong interpersonal skills with ability to build consensus and work effectively in teams

This is a permanent position, with a competitive salary and benefits package.

Please send your CV with a covering letter by clicking Apply.

GMP QA Associate

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell therapies. Originating from pioneering research at UCL, CRUK and the Francis Crick Institute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1Q 2020.

Role Summary:
We are seeking a GMP Quality Associate to primarily perform and support QA duties at a manufacturing site for Achilles product (Investigational Medicinal Product), thereby ensuring GxP and other regulatory requirements relating to clinical trial manufacture are met and maintained. The role will also support the separate Achilles Quality Management System, ensuring activities conform to regulatory requirements.
This is a unique opportunity to join a company in an exciting start-up phase that has the ability to transform the clinical management of cancer.

Responsibilities:
• Support the Achilles Quality Management System (QMS) ensuring activities conform with regulatory requirements
• Routine QA duties to ensure GxP and other regulatory requirements relating to manufacture and clinical trials
• QA duties and support at the manufacturing site (Centre for Cell Gene and Tissue Therapeutics (CCGTT)) for Achilles product
• Routine QA duties include activities within the following systems: Document management; Creation, review and approve Quality and GxP related documents; Deviation management including Risk escalation and investigations; Vendor qualification; Change Control; Corrective and Preventive Action (CAPA); Complaint and Recall handling; Training; Batch Record Review; Qualification & Validation; Internal Audits and External Audits (as necessary); GxP Data review including Regulatory Submission
• Support of provision of QA GxP and associated in house training activities eg SOPsSOP Index maintenance
• Work with QA CCGTT and CCGTT QMS
• Provide support and data for Achilles Quality Management Reviews, as required
• Work with QA Achilles and Achilles QMS
• Enhancement of Achilles QMS
• Support activities within Achilles QMS, as assigned

This position requires:
Education
• Scientific degree (B.Sc) or equivalent in Chemistry, Biology or Pharmacy or closely related subject

Skills
• Demonstrable ability to review and critique GxP documents and data
• Demonstrable ability to write/review SOPs and in compliance with company and global regulatory expectations
• Technical expertise/knowledge of quality requirements for aseptic manufacturing processes and laboratory techniques
• Demonstrable ability on training staff including cross functional team members
• Demonstrable ability to work cross functionally fostering Teamwork and Cooperation to achieve quality outcomes and objectives
• Influencing skills
• Attention to detail and accuracy in assigned tasks
• Ability to prioritise workload and work with minimal supervision
• Good working knowledge of using Microsoft Office programmes
• Proficient in English Language

Experience
• 2+ years working in QA in a Biotech/Biologics/ATMP GMP environment ideally on MIA /MIA IMP licensed site
• 3+ years working within GMP or closely related Quality Management System
• Thorough understanding of EU and US GMP requirements – 2001/20/EC, 2001/83/EC, 21 CFR Parts 11, 210, 211
• In depth understanding of Clinical Trial Directives/Regulations, as pertains to clinical product
• 2+ years of technical knowledge of aseptic manufacturing processes, sterility assurance and laboratory techniques
• Experience with Equipment Qualification activities
• Experience of working with Sponsors, contract manufacturing organisations and contract testing laboratories
• Experience with batch and associated documentation and its review
• Experience with Validation Plans, activities and reports
• Experience with document preparation/review in support of regulatory submission packages

Desirable
• Experience with Environmental Monitoring
• Experiences with Clean Rooms
• 2+ years working in QC GMP environment
• Knowledge about regulatory requirements for ATIMPs
• Knowledge on HTA requirements for Cells and Tissues

This is a permanent position, based within a manufacturing site in London with a competitive salary and benefits package.
Please send your CV with a covering letter by clicking Apply.

Medical Director, Clinical Development

About Achilles Therapeutics:
Achilles Therapeutics is a company focused on the development of T cell therapies tar-geting clonal neoantigens for the treatment of cancer. We use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient and develop personalised T cell ther-apies. Originating from pioneering research at UCL, CRUK and the Francis Crick Insti-tute, we are using our ground-breaking immuno-oncology approach to rapidly advance therapies, with our first products for Non-Small Cell Lung Cancer and Melanoma expected to enter the clinic in 1H 2020.

Role:
We are seeking a Medical Director, Clinical Development with experience working in oncology or haematological malignancies, to join our growing company and support the development of a next generation personalised cancer medicine. As a Medic at Achilles Therapeutics, you will report directly to the Chief Medical Officer and work closely with other members of the senior leadership team to deliver the medical strategy and establish overall benefit, risk and value of ATL001 as well as future therapies.

Responsibilities:

Study Level Tasks:
• Medical monitoring activities e.g:
• Review subject eligibility and protocol deviations; respond to site queries
• Train site teams and CRAs in the relevant therapy area, clinical study protocol and investigational product
• Conduct regular medical review of safety, coding, labs and efficacy data to ensure accuracy and consistency
• Ensure data quality ahead of database locks for interim analyses of safety and efficacyContribute to writing clinical protocols and other study-related documents
• Ensure rapid SAE processing and documentation (assessment, relatedness, queries, narratives)

Clinical Development Tasks:
• Contribute to the Clinical Development Strategy
• Contribute to the design and interpretation of clinical studies
• Ensure the safety of patients participating in all clinical trials of ATL001
• At the request of the CMO, represent Achilles in interactions with external stakeholders (e.g., regulatory authorities, pricing and reimbursement bodies, key opinion leaders, advisory boards, potential industry partners, potential Investors, patient advocacy groups), and internal stakeholders (e.g., CEO, Scientific Founders, Board members)
• Contribute to the delivery of the translational science strategy
• Effectively communicate project status, risks and issues to CMO
• Contribute to writing clinical components of regulatory documents (e.g., Investigators’ Brochure, DSUR, clinical components of regulatory submissions
• Contribute to writing abstracts, presentations, and manuscripts

Education and Experience:
• MD or PhD with expertise in oncology or haematological malignancies, and relevant experience of clinical trials in either an industry or academic setting
• Excellent scientific and analytical skills
• Excellent interpersonal skills, with demonstrated ability to interact effectively with peers and a variety of stakeholders
• Desirable but not essential: experience in immune-oncology or cell and gene therapies

This is a permanent position, initially based in Stevenage but relocating to West London in 2020. This position offers a competitive salary and benefits package

The role offers a competitive salary and benefits package to match experience.

Please send your CV with a covering letter by clicking Apply.