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Precision Medicine Operations

3 months ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage
Posted Date: Aug

Are you energized by the challenge of supporting clinical trial operations and getting ahead of disease together for the benefit of patients? If so, we have a great opportunity for you on the Precision Medicine Project Management and Operations (PMedPMO) team at GSK We are looking for an operations specialist with knowledge and experience in drug development, bioanalytical expertise, clinical operations, sample management, and project management to support our robust pipeline of clinical studies. The successful candidate will be based out of our Upper Providence, Pennsylvania site or Stevenage, UK site working 2 or 3 days per week onsite.

As a Precision Medicine Operations - Investigator you will support end to end clinical operations for resourcing and budgetary planning activities, as well as business performance tracking across Biomarker Platforms (e.g., trusted partner contract research organizations (CROs), various analytical platforms and therapeutic modalities, reagent generation, automation, etc.). This includes all Biomarker Platforms' deliverables in clinical studies, for the supported assay measures (Pharmacokinetics, Immunogenicity including ADA and NAb, PD Biomarkers, Diagnostic Biomarkers, and Exploratory Biomarkers), from study start-up to regulatory submission. You will be the primary operational interface with internal partners (e.g., Biomarker Platforms extended Leadership Team, Scientific Technical Experts, Bioanalytical External Study Monitors) and external collaborators (e.g., Clinical Study Teams, Clinical Pharmacology Modeling and Simulations, Clinical Biomarker Leads, DMPK Project Specialists, Data Management, Stats/Programming, and Project Managers).

Key Responsibilities

This role will provide YOU the opportunity to lead key activities and progress YOUR career, these responsibilities include some of the following...
  • Lead the planning activities across various scientific lab groups in Biomarker Platforms, for all Biomarker Platforms-owned measures (Pharmacokinetics, Immunogenicity including ADA and NAb, PD Biomarkers, Diagnostic Biomarkers, and Exploratory Biomarkers) to support clinical study milestones.
  • Act as a central Biomarker Platforms contact for asset-driven clinical study/project team on all planning activities (e.g., analytical timelines, budgeting, scientific coordination).
  • Responsible for coordination of the bioanalytical portion of clinical study support conducted in-house or at CROs, focusing on required clinical assay measure deliverables, resource and budgetary requirements, and protocol review for contract generation.
  • Using your operational skills, you will oversee the coordination of assay requirements, reagent development, resource placement, and performance tracking for GSK clinical studies.
  • Work with Project Managers to deliver an accurate project plan for clinical study assay measures, provide budget and resource forecasting, invoice approval, and keep the project plan live throughout the study.
  • Support provision of productivity, resource, and capacity data and analysis for Biomarker Platforms' Leadership Team.
  • Track progress, business performance, concern escalation, and issue resolutions on all Biomarker Platform deliverables to study/project teams for both internally and externally supported project work.
  • Interface with scientific leads to determine CRO selection and provide invoice approvals for executed work.
  • To understand and meet the requirements of all relevant GSK policies, SOPs, and external regulations. To understand and comply with local codes of practice, guidelines, and laws.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's or master's degree in Biological/Chemical/Pharmaceutical Sciences, Business or Project Management.
  • Minimum 5 years of working in the pharmaceutical industry.
  • Minimum 3 years of experience with clinical PK Bioanalysis, PD Biomarker, Exploratory Biomarker, Immunogenicity, and/or cellular assay delivery requirements.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Knowledge of drug development process; especially of biotherapeutics, as it applies to technical, logistical, and regulatory requirements for PK bioanalytical, immunogenicity, PD biomarker, and exploratory biomarker assays across multiple technical platforms.
  • Experience representing the bioanalytical function and driving/delivering bioanalytical strategies and commitments to clinical study teams in a highly matrixed environment.
  • Experience coordinating multiple demands and timelines (> 6 assets or 30+ clinical studies), stakeholder influence, and managing expectations.
  • Excellent organizational, interpersonal, and written/verbal communication skills with internal and external partners.
  • Minimum 1 year of experience in working with leaders to define project/study strategies and deliverables.
  • Strong understanding of regulatory guidelines from health authorities and previous minimum work experience of 1 year under GLP, GCP, and/or GMP.
  • Strong understanding of clinical PK Bioanalysis, PD Biomarker, Exploratory Biomarker, Immunogenicity, and/or cellular assay technical limitations.


#LI-GSK

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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