Associate Director, LC-MS Bioanalytical External Study Monitor

Site Name:

USA - Pennsylvania - Upper Providence, UK - Hertfordshire - StevenagePosted Date:

Aug 26 2024We’re currently looking to expand our Bioanalysis and Biomarkers Platforms (BBP) department within Precision Medicine and seeking an Associate Director to join with strong exposure to LC-MS PK and biomarker end points. The role is based in the R&D hub in 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 GSK's studies. Your skills as a bioanalytical scientist with drug development and regulatory understanding will help you work with internal and external partners to deliver bioanalytical endpoints for clinical studies across the GSK portfolio.As a senior BESM, 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, and 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 biomarker are delivered to pre-agreed project timelines and quality standards. You will contribute to bioanalytical sections in the regulatory submission packages worldwide and make recommendations on the CRO selections based on their key performance index (KPI).This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Contribute to bioanalytical sections in the regulatory submission packages worldwide, especially in the emerging markets.Provide bioanalytical life-cycle support for all phases of clinical trials, especially late phase assets.Lead bioanalytical projects in line with agreed departmental/project timelines.Act as Sponsor Reviewer (SR) for Bioanalysis and Biomarker Platforms studies and study contributions outsourced to contract research organizations (CROs).Act as the primary interface for communication between GSK and CRO staff.Work closely with CRO partners to ensure timelines for method transfer, validation, 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 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 Bioanalysis and Biomarker Platforms internal group and manage reference standard and internal standard distribution from Bioanalysis and Biomarker Platforms to CROs and ensure CRO possesses unexpired standards for the conduct of the study.Represent the department in internal project teams and regulatory interactions (questions, and filings) related to LC-MS assays.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:PhD or MS in Chemistry, Biochemistry, or related discipline, with 5+ years of pharmaceutical industry bioanalysis experience, or BS in Chemistry, Biochemistry, or related discipline with 10+ years of pharmaceutical industry bioanalysis experience.Experience delivering bioanalytical methods (i.e. method development, method validation, troubleshooting, etc.).Pharmaceutical industry regulated bioanalysis experience.Developing and validating methods to support validation of bioanalytical LC-MS assays.Experience preparing analysis and reporting of clinical new chemical entity (NCE) PK, biomarker data, and its context to the study/project.GLP, GCLPs, and regulatory guidance experience.Must have represented 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.English both spoken and written.Preferred Qualifications:If you have the following characteristics, it would be a plus:Previous study monitoring experience.Experience in mentoring young scientists in a regulated bioanalysis environment.Peer recognition in the pharmaceutical industry by publication at peer review journals and podium/poster presentations at international conferences.Experience of quantitative LC-MS bioanalysis of protein biomarkers.Experience of contributing to bioanalytical sections in the regulatory submission packages worldwide, especially in the emerging markets.Experience in study setup and management of regulated studies in Thermo Watson LIMS.Experience in tools or software for tracking CRO key performance index and study/schedule plan.Experience of working through contract negotiations with partners and third 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.Cultural sensitivity.Willingness to travel if needed.#LI-GSK

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