Associate Director, PK and Biomarker Immunoassay Stevenage, England
Job description
Posted Date: Jun 15 2023
We’re currently looking to expand our Bioanalysis, Immunogenicity and Biomarkers (BIB) department and seeking an Associate Director to join with strong exposure to Immunoassays for PK and Soluble Biomarker end points. The role is based in the R&D hub in Stevenage UK or Upper Providence US.
As the successful candidate, you’ll join GSK in a high visibility role where you’ll be at the forefront of medicine while managing the full life cycle of GSKs studies. Your skills as a bioanalytical scientist with drug development and regulatory understanding will help you working with internal and external partners to deliver bioanalytical endpoints for preclinical and clinical studies across the GSK portfolio.
You will serve as the subject matter expert (SME) on PK and Biomarkers data deliverables using various immunoassay platforms (e.g., ELISA, Gyros, MSD, Quanterix), and work closely with internal biomarker leads to define the necessary Context of Use for the data and ensure supporting analytical methods are fit for purpose. As a bioanalytical external study monitor, you will manage the bioanalytical support externalized to CRO partners covering method development, assay transfer / validation (including cross validation), and work closely with internal team members to define timeline, outsourcing strategy, develop new processes for outsourcing to better optimize the outsourcing workflow. You will monitor assay performance at CRO and ensure high quality PK and/or soluble biomarker are delivered to pre-agreed projects timelines and quality standard.
In this role you will
The primary deliverables for the Associate Director, PK and Biomarker Immunoassay will be to:
- Act as the SME for biopharmaceutical PK and soluble biomarker immunoassays, internal and external; provide technical supervision in solving issues related to PK and soluble biomarker assays in preclinical and clinical development
- Act as Sponsor Reviewer (SR) for BIB studies and study contributions outsourced to contract research organizations (CROs)
- Acts as the primary interface for communication between GSK and CRO staff. Work closely with CRO partners to ensure timelines for method development and sample analysis are met and communicate any delays
- In partnership with GSK External QA, evaluate third-party compliance with GLP, GCP Clin Lab, and worldwide regulations, relevant SOPs, protocols, policies and procedures
- Work closely with Planning & Performance Specialist (PPS) team and interact with internal GSK stakeholders to fulfill the requested timeline and data/report delivery.
- Review and contribute to clinical study report and assist the regulatory filing.
- Interact with BIB reagent group and manage reagent distribution from BIB to CROs and ensure CRO possess unexpired critical reagents for the conduct of the study.
- Represent the department in internal project teams and regulatory interactions (questions, and filings) related to PK/PD assays
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Experience working within the pharmaceutical industry with intimate understanding of the drug development process
- Expertise in developing methods to support validation of biopharmaceutical PK, biomarker or immunogenicity assays
- Experience in preparing analysis and reporting of preclinical and clinical biopharmaceutical PK, biomarker and immunogenicity data and its context to the study/project
- Thorough understanding of GLPs, GCLPs, and regulatory guidance’s
- Experience in representing the department at project teams and regulatory interactions (questions, and filings)
- Accomplished data interpretation experience both bioanalytically as well as secondary outputs such as PK PD
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Previous global/at least regional function and experience in major pharma (regulated industry) organization are preferred
- Experience in study set up and management of regulated studies in Thermo Watson LIMS
- Experience of working through contract negotiations with partners and 3rd parties
- Excellent communication skills – will need to interface between many functional areas including external suppliers, internal study teams, SMEs and QA
- Excellent attention to detail – reviewing validation plans, study plans, validation and bioanalytical reports, and assisting with reconciliation of study samples
- Willingness to travel if needed
Closing date for applications:
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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