Diagnostic Delivery Lead

GSK; United States; A distancia; USD 123.000 - 205.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Long-term incentive program

Health insurance

Descripción de la vacante

GSK is seeking a Diagnostics Delivery Lead within Oncology Translational Medicine to own operational delivery of diagnostic plans across early to late-stage trials. You will manage biosample collection, assay deployment at reference labs and CROs, and ensure data is audit-ready for analysis.

Collaborate with Clinical Operations, Data Management, and Regulatory teams in a matrix environment. You will drive process improvements, mentor colleagues, and ensure regulatory and quality standards are

Formación

• Bachelor’s degree in life sciences or related field required.
• Experience in project or delivery management within diagnostics, clinical development, or healthcare.
• Knowledge of diagnostic technologies and their clinical/trial applications.
• Understanding of regulatory requirements and quality standards relevant to diagnostics.
• Strong organizational and communication skills with diverse teams and partners.

Responsabilidades

• Own operational delivery of diagnostics across assigned studies, from biosample collection to data ready for analysis.
• Define biosample collection, processing, and storage plans with cost management.
• Oversee implementation of clinical trial assays at reference labs and CROs; manage vendor oversight.
• Provide diagnostic input to protocols and informed consent forms; train CRO and internal teams.
• Ensure audit readiness and collaborate with data management on data requirements and transfers.
• Drive process improvements and mentor colleagues; align with strategy and quality standards.

Conocimientos

Delivery management

Cross-functional collaboration

Regulatory & quality awareness

Communication

Vendor & contract management

Biomarker/diagnostic tech familiarity

Agile thinking

Time management

Educación

Bachelor's degree in life sciences

Master’s degree or higher in a relevant field

Descripción del empleo

The Diagnostic (Dx) Delivery Team within Oncology Translational Medicine is a group of scientific operations professionals who turn clinical diagnostic strategy into reality across early and late-stage oncology trials. As Diagnostic Delivery Lead, you will own the operational delivery of diagnostics within your assigned studies: from biosample collection and clinical trial assays at reference and central laboratories, to data that is ready for analysis, always audit-ready. You will work in a matrix with Diagnostic Strategy, Biomarker, Clinical Operations, Data Management, Regulatory, Quality and Procurement colleagues, and with external CROs, laboratories and vendors.

• Implement clinical diagnostic plans for oncology programmes in early and late-stage development, ensuring audit readiness at all times, and identify, document and manage project risks.
• Define and deliver biosample collection, processing and storage for your studies (inputting in lab manuals, kits, database set-up), ensuring logistical feasibility and cost-effectiveness, and forecast and manage biosample analysis and sample management costs.
• Manage the implementation of clinical trial assays at reference labs, central labs and CROs, including contract execution and vendor oversight, and act as the key contact for assay laboratories.
• Provide diagnostic input to protocols, informed consent forms and other study documents; work with Clinical Operations on site communications and training materials, and train CRO and internal teams on sample collection and processing.
• Align with Data Management and Biostatistics on data requirements, contribute to data transfer agreements and ensure data is ready for analysis; act as first point of contact for biosample operational questions, resolving or escalating issues and providing regular status updates, including sample tracking reports.
• Drive process and system improvements, coach and mentor colleagues as a subject matter expert, and role-model GSK values.
  We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
• Bachelor's degree in life sciences, biomedical science, or a related discipline.
• Experience in project or delivery management within diagnostics, clinical development, or healthcare settings.
• Knowledge of diagnostic technologies and their application in clinical trials or healthcare delivery.
• Understanding of regulatory requirements and quality standards relevant to diagnostics.
• Strong organisational and communication skills with the ability to engage diverse teams and partners.
• Ability to manage multiple priorities and navigate a fast-paced, matrix working environment., Master's degree or higher in a relevant scientific or healthcare discipline.
• Experience working within pharmaceutical or biotechnology companies, especially in diagnostic or clinical operations roles.
• Familiarity with advanced diagnostic technologies or biomarker development.
• Experience managing vendor relationships and contracts.
• Demonstrated ability to contribute to process improvements and implement best practices.
• A collaborative and proactive approach to problem-solving and stakeholder engagement., Agile Thinking, Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Cross-Departmental Collaboration, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Learning Agility, Matrix Leadership, Stakeholder Management, Time Management
  At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. We are ambitious for patients, accountable for impact, and committed to doing the right thing, uniting science, technology, and talent to get ahead of disease together., Why GSK?
• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $123,000 to $205,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive