We are excited to see you are interested in working for A4P.
As a diverse and engaging workplace, we are always looking for forward-thinking and motivated people to join our teams.
Why work for us? Our success to date is all due to our employees who we hope to inspire and develop while working in their chosen roles. We thrive to provide our employees with the best work-life balance through ensuring flexibility and help where needed.
Main Responsibilities
The focus of this role is in bioanalytical scientific oversight, leading the delivery of assay developments/ validations and project management of outsourced bioanalysis at contract research organisations. Our team of experts work together with Pharmaceutical companies in support of pre-clinical and clinical trials for a wide variety of therapeutic areas.
The responsibilities will be to:
- Provision of expert resource for the oversight and management of method establishment and fit for purpose assay validation.
- Provide expertise and knowledge in the application and operation of quantitative bioanalytical techniques (predominantly ligand binding assays).
- Provide to A4P clients in allocated projects, input into client project meetings, review and input of bioanalytical elements required in key planning and operational documents and regular communication updates to clients on progress of outsourced activities.
- Interact effectively with various client functional/stakeholder groups involved in sample analysis and data processing. These may include the client’s CRO facing sample managers, CRO laboratory based bioanalytical scientists, pharmacokinetic and pharmacology experts, data acquisition function and sample repository representatives.
- Provision of expert input and resource in sourcing, selecting and engaging appropriate CRO providers for clients.
- Uploading and verification of bioanalytical data generated by CROs to client data servers and reporting processes.
- Review of assay validation and bioanalytical reports.
- Develop and operate communication strategies and activity reviews of the outsourced bioanalytical activities undertaken by selected providers.
- Update and maintain CRO activity and KPI performance monitoring and tracking documents and tools as required by clients.
- Contribute to ongoing development of A4P bioanalytical products and services.
Profile
Job Location:
The role can be undertaken from a home office-based location or from A4P offices at Innovation House, Discovery Park, Sandwich, UK. For a home-based employee attendance on a needs-to basis at the A4P offices will be required.
Additionally, the role may require travel and attendance at A4P client’s company’s research and development sites and locations. The times required for that will vary dependent upon A4P and client needs and requirements.
Education and Experience
- Degree/ masters level equivalent in a chemistry / biochemistry / biological science or similar discipline with relevant pharmaceutical research and development experience in regulated bioanalysis.
- Extensive knowledge and competencies in application and practice of bioanalysis within regulatory environments (GLP and GCP).
- Comprehensive knowledge and competencies in design and operational execution of clinical and pre-clinical studies, toxicokinetic and pharmacokinetic analysis.
- Demonstrable significant understanding of the research activities and requirements undertaken within a drug development organisation.
- Practical experience of managing and developing bioanalytical methods, assay validation and study data generation in clinical and pre-clinical studies.
- Experience in the pharma or CRO industry supporting regulatory bioanalysis in a regulatory and clinical trial environment.
- Knowledge of the application and operation of a range of bioanalytical techniques employed for regulatory soluble target and biomarker analysis, including but not limited to ligand binding assays.
- Knowledge of the latest regulatory standards required for GXP studies including international guidance’s published by regulatory agencies such as FDA, EMA.
- Previous experience managing contract research organisations.
- Experience with change and quality management.
Personal Attributes
- Engaging, enthusiastic, self-motivated, confident, self-assured and a team player. Willing to interact with large organizations on behalf of a small company
- Demonstrable ability to prioritize activities with strong attention to detail and effectively multi-task across deliverables
- Excellent communication skills in both written and oral areas. Strong presenting skills
- Gain client trust and confidence in A4P abilities to deliver clients objectives and requirements
- Willingness and availability to travel and work at client’s site(s) for short periods of time.
- Willingness and availability to travel and work at A4P’s location in Sandwich, Kent on regular (frequency negotiable) basis for duration of employment.
- Demonstrable significant understanding of the research activities undertaken within a drug development organization
- Ability to develop effective relationships with external service partners
- Full driving licence may be advantageous though not essential
Salary and Benefits:
Salary negotiable with reimbursable travel expenses. A4P operate a discretionary rewards and recognition scheme for performance and deliverable activities. A4P offer 25 days annual paid leave (excluding public holidays).
Hours of Work: This position is a full-time role based on 37.5 hrs. per week, excluding lunch & holidays with an initial 3-month probationary period. A4P operates a degree of informal flexibility as regards working hours attendance.
Benefits: A4P offer staff membership of BUPA Healthcare and Dental Schemes on successful completion of the probationary period
Job Application - Bioanalytical Project Manager (Biomarker expertise)
Main Responsibilities
The successful candidate will be responsible for ensuring strategic operational input into clinical laboratory testing of human biological specimens and the efficient operational deployment of such clinical laboratory testing at the programme level (including biomarkers, central safety testing and clinical bioanlysis for pharmacokinetic assessment).
The responsibilities will be to:
- Provide appropriate operational contribution to the inclusion of laboratory testing of human biological specimens into clinical programmes and trials
- Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of clinical biosamples (including companion diagnostic samples) – collection, processing, analysis, data delivery process and final sample disposition
- Ensure all the laboratory components within planning operational delivery documents are accurate and fit for purpose. Ensuring strategy for the sampling plan is deployed and lessons learnt are communicated to the study level personnel to ensure optimal synergies of activities for study level activities in assigned projects
- Collaboration with Biomarker scientists as well as operational teams, diagnostic partners, external CRO & Central Labs, and biomarker vendors to execute the biosample operational strategies on one or multiple studies/projects
- Management of the development and oversight of the biosample analysis timelines, budget, risk and quality plans
- Oversee delivery of laboratory services and data from external providers at a project level.
- Provide rapid, regular and frequent updates of all activities to the clinical study teams.
- Contribute to ongoing development of A4P products and services
- This list is not exhaustive and other tasks in line with the role might be assigned
Profile
Education and Experience
- Proven experience in clinical development and operational deployment of biological assays obtained in a major pharmaceutical company or large CRO organisation within a project management role is required.
- Proven experience in oversight of external partners, laboratory service providers is required.
- Biological laboratory experience and biomarker scientific background is desirable.
Personal Attributes
Engaging, enthusiastic, self-motivated, confident, self-assured and a team player. Willing to interact with large organizations on behalf of a small company
- Demonstrable ability to prioritize activities with strong attention to detail and effectively multi-task across deliverables
- Excellent communication skills in both written and oral areas. Strong presenting skills
- Gain client trust and confidence in A4P abilities to deliver clients objectives and requirements
- Willingness and availability to travel and work at client’s site(s) for short periods of time.
- Willingness and availability to travel and work at A4P’s location in Sandwich, Kent on regular (frequency negotiable) basis for duration of employment.
- Demonstrable significant understanding of the research activities undertaken within a drug development organization
- Ability to develop effective relationships with external service partners
- Full driving licence may be advantageous though not essential
Hours of Work: This position is a full-time role based on 37.5 hrs. per week, excluding lunch & holidays with an initial 3-month probationary period. A4P operates a degree of informal flexibility as regards working hours attendance.
Benefits: A4P offer staff membership of BUPA Healthcare and Dental Schemes on successful completion of the probationary period
Job Application - Clinical Biosample Operations Project Manager
Main Responsibilities
Working within a Translational Medicine department of one of our clients, we are looking for a highly motivated individual to coordinate the preparation, implementation, and follow-up of biological analyses (ie PK, PD and biomarkers) in clinical trials in close interaction with Translational Medicine scientists, Clinical Study managers, Clinical Leads, Medical Directors and CROs. The successful candidate will be autonomous, proactive and collaborative with experience working in a clinical development environment.
The responsibilities will be to:
- Contribute to the preparation of biological analyses in clinical trials by
- participating to the selection of analytical laboratories (including service providers and/or commercial partners),
- managing contracts with the support of a legal advisor,
- planning and following-up the activities related to the implementation of biological analyses in clinical trials (e.g. assay transfer, kit preparation, sample collection procedures, shipping requirements, CRF review, analytical data collection/reporting and data transfer) with different service providers.
- Follow-up and monitor the activities related to biological analyses during ongoing clinical trials (including coordination with the central lab and the other laboratories, follow-up of samples), identify study or project issues and solve them. Contribute to the preparation of the budget related to these activities as well as its follow-up.
- Collaborate on the transfer, review and analysis of the corresponding results and ensure appropriate data review and accurate data reporting.
- Support the development of dedicated sections of interim analysis and study report.
Profile
- You hold a Bachelor or Master degree in Life Sciences or PharmD.
- Ideally, you have a minimum of 3-year experience in organizing, implementing and monitoring analysis of biological markers during clinical trials, but candidates with less biomarker specific experience who have extensive experience in clinical operations will also be considered.
- Experience in oncology/immuno-oncology is an advantage.
- Prior experience in a laboratory environment is important to be able to coordinate experiments in clinical settings.
- Experience in the follow-up of contractual aspects and relations is an advantage.
- You have strong problem-solving skills
- You are open-minded and have excellent interpersonal and communication skills.
- You have a good understanding of GCP/GCLP guidelines and current global regulations.
- You are fluent in English (oral and written), French language would be useful.
- Well organized and resilient, you are able to adapt to changes in priorities and to work effectively on multiple programs in a fast-paced environment.
- Although largely autonomous, you are collaborative and are happy to work with internal and external stakeholders.
- You master Standard Office tools (knowledge in MS project is an asset.
- Since the job scope/role could evolve as the company grows, you can adapt to changing needs.