Associate Director, Diagnostic Planning Lead - Oncology

GSK

Upper Providence (Delaware County)

On-site

USD 120,000 - 160,000

Full time

3 days ago
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Job summary

GSK's Diagnostics Planning Team within Oncology Translational Medicine seeks a Dx Planning Lead to overseeDx development activities, coordinate internal and external collaborations, and drive documentation for regulatory submissions. The role requires leading cross-functional teams and ensuring milestones, timelines, and budgets are met.

Ideal candidates have 7+ years in project/program management in diagnostics/pharma, plus familiarity with drug discovery, clinical trials, and regulatory

Qualifications

  • Bachelor's degree in biological sciences or related discipline.
  • 7+ years of project or program management experience in diagnostics/pharma/biotech.
  • Experience managing clinical biomarker or diagnostic development programs.
  • Knowledge of drug discovery, clinical trial design and regulatory concepts.

Responsibilities

  • Lead cross-functional project teams across Clinical Development, Data Management, QA, Regulatory, and Finance.
  • Represent GSK to external partners to ensure scope, cost, quality, and timeline milestones.
  • Plan, track, and communicate timelines, milestones, and goals to teams and stakeholders.
  • Monitor budgets, milestones, payments, and invoices for diagnostics projects.
  • Organize internal and external meetings; document discussions and actions for follow-up.
  • Contribute to strategic planning aligning with Oncology Translational Medicine goals.
  • Manage multiple projects concurrently with accountability and urgency.

Skills

Project management
Cross-functional leadership
Biological sciences
Budget management
Risk management

Education

Bachelor's degree in biological sciences or related discipline

Tools

MS Project
Power BI
MS Teams
SharePoint

Job description

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. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Find out more:

Our approach to R&D
Position Summary

The Diagnostics Planning Team within Oncology Translational Medicine (OTM) is a dedicated group of Project Management professionals. The Dx Planning Lead works in collaboration with Diagnostics (Dx), Biomarkers (BMx), Clinical Pharmacology Modeling & Simulation (CPMS), Clinical Development, Clinical Operations, Human Biological Sample Management, Data Management, Quality, Regulatory, Commercial, and Finance, as well as external laboratories, collaborators, and Dx manufacturers, to progress OTM Dx activities and deliverables to support the Oncology portfolio. The Dx Planning Lead leverages subject matter expertise to provide oversight to various aspects of the Dx development, coordinates meetings and project deliverables internally and with external partners, organizes documentation to support regulatory submissions and to meet compliance requirements, and assists teams with technical evaluations of technologies. The Dx Planning Lead is responsible for ensuring internal stakeholder alignment, creating integrated project/program timelines, tracking and verifying completion of project deliverables and milestones, identifying and mitigating project risks, and timely communication to relevant stakeholders within OTM. Additionally, the Dx Planning Lead will reconcile activities with contracting and finance operations.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Lead cross-functional project teams to support OTM Teams by coordinating activities across Clinical Development, Clinical Operations, Data Management, Quality, Regulatory, Procurement, Finance, and Commercial
  • Represent GSK to external partners to ensure project objectives meet scope, cost, quality, and timeline milestones
  • Analyze, plan, and track project activities (define opportunities for acceleration); manage costs, risk, and schedule. Communicate timelines, milestones, and goals on a routine basis to the OTM project team and other stakeholders
  • Track and update project budgets, milestones, and payments; includes management of diagnostic contracts and approval of invoices
  • Organize internal scientific/strategy meetings as well as meetings with external partners (e.g., Joint Project Team meetings, F2F meetings, etc.), provide expert records of discussions, and ensure timely resolution of actions
  • Oversee and contribute to strategic planning to align with OTM goals by enabling Subject Matter Expert-driven support to programs by leveraging broad knowledge of biomarker technologies, Dx development, and IVD expertise
  • Successfully multi-task amongst several competing initiatives
  • Demonstrate accountability and urgency for the timely completion of OTM projects
Why You?
Basic Qualification
  • Bachelor's degree in biological sciences or related discipline
  • 7+ years of project or program management experience in the diagnostics (Dx), pharmaceutical, or biotech industries
  • Experience managing clinical biomarker or Diagnostic development programs
  • Experience with drug discovery and development, clinical trial design, and overall principles of clinical development
Preferred Qualification
  • Master's degree or Ph.D. in a relevant scientific discipline
  • PMP or PRINCE2 certification
  • Prior Project Manager or Program Manager experience in diagnostics.
  • Solid understanding and application of Project Management principles, concepts, practices and standards
  • Recent oncology project management experience
  • Experience in both diagnostics (Dx) and pharmaceutical or precision medicine development, including direct contributions to analytical and clinical validation studies
  • Hands-on experience with Microsoft Project or equivalent, Word, Excel, PowerPoint, Outlook, SharePoint, remote meeting tools such as MS Teams, WebEx, etc. and a working understanding of innovative AI technologies (e.g., CoPilot, ChatGPT, GiGi, Jules, PowerBI, etc.)
  • Demonstrated ability to think strategically, work effectively in a matrixed environment, and execute multiple projects simultaneously
  • Excellent time management skills, well organized, and fo
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