Precision Medicine Operations - Investigator Compare GSK, Pharmaceutical & Biotechnology Steven[...]

Precision Medicine Operations - Investigator Salary average
-
YEAR
Type of employment
Full-time
Company We are a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.We prioritise innovation in vaccines and specialty medicines to prevent and treat disease. ResponsibilitiesThis 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. Skills used at work Posted Date: Apr 1 2024Are 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.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 ResponsibilitiesThis 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.5+ years experience working in the pharmaceutical industry.3+ years 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-GSKPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why Us?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 organization 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.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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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