Description
Overview
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
Job Purpose
Provide technical expertise and project manage a range of bioanalytical activities on behalf of A4P’s contracted clients. This includes the oversight of outsourced bioanalysis at contract research organisations for clinical and pre-clinical drug development.
Job Role
- Oversight and management of method development, validation and sample analysis studies at contracted CROs.
- Provide technical input in the application and operation of quantitative bioanalytical techniques.
- Provide technical and regulatory expertise on bioanalytical strategies during client meetings.
- Ensure regular updates on progress of outsourced activities to sponsor.
- Interact effectively with client’s stakeholders including outsourcing experts, data managers, pharmacokinetic experts etc.
- Source, select and engage with appropriate bioanalytical CROs for clients’ outsourced activities.
- Review bioanalytical data generated by CROs.
- Review draft validation plans, reports and study documents.
- Ensure effective communication strategies with contracted CROs.
- Monitor CRO’s activity and KPIs as required by clients.
- Oversight of biosample operations including central lab set up support.
Job Location
The role can be undertaken remotely or from the A4P offices at Innovation House, Discovery Park, Sandwich, UK. For a home-based employee travel on a needs-to basis to the A4P offices will be required. Additionally travel to client’s or vendor’s sites may be requested by A4P’s client.
Required Experience
Degree / master's level equivalent in a biochemistry / biological science or similar discipline with a minimum of 10 years relevant pharmaceutical research experience in regulated bioanalysis. Extensive knowledge in regulatory environments (GLP/ GCP) including PK / PD analysis. Knowledge of ligand binding assays such as ELISA etc., comprehensive knowledge in design/execution of clinical studies. Significant understanding within drug development organisations is essential along with practical experience managing/developing methods in clinical studies.
Desirable Experience
Experience analyzing complex modalities including ADC's; PCR/Flow Cytometry experience; knowledge regarding EU IVDR regulations; previous management experience within contract research organisations; change/quality management experience; input into regulatory submissions.
Personal Characteristics
Engaging self-motivated team player willing to interact across various organisation sizes. Strong attention to detail while effectively multi-tasking across deliverables focused towards client needs is essential along with excellent communication skills both written/oral.
Salary And Benefits
Salary negotiable plus reimbursable travel expenses. Discretionary rewards scheme based on performance is available alongside 25 days annual paid leave excluding public holidays.
Hours Of Work
This position is full-time based on 37.5 hrs per week excluding lunch & holidays initially under a 3-month probationary period allowing informal flexibility regarding working hours attendance.
Perks Our LabConnectors Love:
We live our values: partnership excellence execution collaboration accountability informed nimble impact making opportunities for career growth friendly collaborative environment open lines communication market-based salary tools provided for job effectiveness
Equal Employment Opportunity Policy
It is LabConnect's policy to provide equal employment opportunities without regard to any protected characteristic under applicable law.
If you have a disability requiring reasonable accommodation please email [email protected] or call +1(423)722-3155 for assistance regarding job openings or applications.For more information visit www.labconnect.com
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