Associate Director, Scientific Leader Assay
il y a 3 semaines
**Site Name**: Belgium-Wavre
**Posted Date**: Mar 8 2024
**Job purpose**:
Expert in clinical assays: Scientific and strategic lead in the development and maintenance of clinical assays to detect and quantify biomarkers. As assay owner, is responsible for the whole life cycle management of clinical assays including the design, development up to validation, maintenance, monitoring, and troubleshooting.
**Your responsibilities**:
- Lead the strategy for the technical development and validation of clinical assays used in one/several clinical trials.
- Lead an in/house lab team working on assay development and validation, performing early-stage development clinical testing. Alternatively, lead the scientific oversight of assay development, validation and clinical testing performed at third party on behalf of GSK.
- Act as assay owner:
- Ensuring assay performance fits its intended use by writing and reviewing the assay target profile.
- Being principal author and controlling assay development, assay qualification reports and assay validation plans in agreement with quality by design principles and fulfill requirements from regulatory authorities. Write and review regularly assay summaries and procedures (SOPs).
- Being principal author of regulatory documents related to clinical laboratory assays
- Developing and controlling the assay maintenance and monitoring plans
- Developing and controlling qualification critical reagent plans
- Transferring assay inside/outside of GSK
- Performing assay troubleshooting and controlled assay continuous improvement
- Writing publications on his/her assay when appropriate
- Manage a team:
- Oversee team delivery, performance, and quality
- Develop and maintain the expertise in multiple assay technologies, support the continuous improvement and innovation
- Perform individual risk assessment for lab technicians and ensure lab activities are performed in agreement to EHS requirement and quality requirement (certification)
- Provide short to mid-term views on the anticipated workload versus capacities of the team, co-ordinate resources according to defined project priorities and CLAP/R&D initiatives
- Ensure all activities under responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations and internal policies.
- Provide support to the VxCLAP CRTLs:
- For the definition of the assay target profile in agreement with the assay intended use in clinical endpoints
- for the development of documents for INDs, regulatory submissions, response to questions from regulatory authorities during submission, inspections
- for the review of the study design and protocol and discussion of study data
- Ensure assay milestones are appropriately planed and communicated to project stakeholders at Project-related CONSO team. Ensure oversight and encoding of activities, resources, and budgets in finance management tools.
- Act as spokesperson as the Assay Scientific Expert on behalf of the CLAP organization to internal and external stakeholders (ie. Communication to outsourcing committee, Preclinical teams, collaboration with academic partners, Key Opinion Leader...).
- Supervise continuous improvements of clinical laboratory processes, introduction of state-of-the-art methodologies, innovative solutions, and cross-functional team efforts.
- Participate to VxCLAP and R&D knowledge management in the field of expertise:
- Provide support related to scientific and technical aspects of the assays to vaccine development/acquisition due diligence, Innovation Project Team. Provide support for the development and/or review of internal and external publications, documents, and communications.
- Provide scientific coaching to lab managers and other CLAP members.
- Participate in the follow up of collaborations with other teams/experts to share/gain scientific and technical expertise and for technology transfer inside (i.e. Preclinical, QC) and outside GSK Vaccines.
**_ Why you?_**
**Basic Qualifications**:
- We are looking for professionals with these required skills to achieve our goals:_
- University degree in Science, pharmacy, or other relevant discipline
- 5 years experience in assay development
- Good Quality culture
- Strong immunology background, experience with respiratory viruses, scientific expertise in Biology and technology including automation.
- Communication across all organizational levels is required. Ability to communicate issues, risks, data, and make decisions. Equally important is the ability to lead within a large matrix international organization
- Proficiency in English, written and spoken
**Preferred qualifications**:
- If _you _have the following characteristics, it would be a plus:_
- PhD in Science or Pharmacy
- Good experience in statistics is an advantage
- Proficiency in French, written and spoken
Li-GSK
If you have a disability and require assistance during the course of the selection process, you will have the opportunity
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