Associate Director, Diagnostic Planning Lead - Oncology

GlaxoSmithKline; Waltham (MA); Hybrid; USD 152,000 - 253,000; Full time

Job summary

GlaxoSmithKline seeks a Diagnostics Planning Lead within Oncology Translational Medicine. You will coordinate cross-functional teams across Clinical Development, Regulatory, and Finance to advance Dx activities and ensure regulatory-compliant timelines.

You will oversee project plans, mitigate risks, and drive external collaborations with laboratories and partners. A strong background in biomarker development and Dx programs is essential for success.

Qualifications

• 7+ years of project or program management experience in the diagnostics, 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.

Responsibilities

• Lead cross-functional project teams to support OTM 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; manage costs, risk, and schedule; communicate timelines and goals to the team.
• Track and update project budgets, milestones, and payments; manage diagnostic contracts and invoices.
• Organize internal scientific/strategy meetings and meetings with external partners; document discussions and actions.
• Contribute to strategic planning to align with OTM goals using SME knowledge in biomarker technologies and Dx development.

Skills

Project management

Biomarker/Diagnostic development

Drug discovery & clinical development

Cross-functional collaboration

Education

Bachelor's degree in biological sciences or related discipline

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.

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

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• 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

If you have the following characteristics, it would be a plus

• 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 focused on results
• Ability to establish trust and work with integrity while motivating others to achieve the goals of the project
• Highly effective communication skills (verbal, written, and presentation) and negotiation skills for a wide variety of audiences/stakeholders, including technical and business

Working model This role is hybrid. You will typically work 2 to 3 days per week onsite at a GSK office, with flexibility to work remotely as needed. #GSK-LI

Skills

• Analytical Thinking
• Clinical Data Interpretation
• Clinical Data Review
• Clinical Development
• Clinical Trial Designs
• Clinical Trials Monitoring
• Cross-Departmental Collaboration
• Digital Fluency
• Drug Regulatory Affairs
• Executive Presence
• Hematology and Oncology
• Learning Agility
• Matrix Leadership
• Scientific Presentations*

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 $151,500 to $252,500. 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.

Please visit GSK US Benefits Summary to 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 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.

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