Associate Director - Diagnostics

Are you a professional in the diagnostics field looking to advance your career? If so, this Associate Director- Diagnostics Oncology Translational Medicine role may be an ideal opportunity to explore!

As a member of the Precision Diagnostics (Dx) team you will contribute to efforts to implement GSK diagnostics strategy(s) to support drug development including technical, clinical, regulatory, commercial, intellectual property and business development components by leading diagnostic projects and work streams according to agreed deliverables, timelines and budget. In this role, you will have the opportunity to lead the development and commercialization of diagnostics in Oncology,

The Associate Director will contribute to Dx development with a culture of collaboration as a member of a matrix cross-functional team.

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

• Support the development of an end-to-end diagnostic strategy within early and late-stage therapeutic clinical studies to align all diagnostic development milestones with clinical development milestones and overall translational biomarker strategy.

• Accountable for tactical aspects of diagnostic development with external partners to develop, validate and implement diagnostic tests required for specific clinical studies.

• Oversee all technical aspects of development, validation and clinical implementation of the diagnostic assays within a clinical study.

• Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements.

• Exhibit timely management and delivery of projects/work streams within agreed budget.

• Works within, and may lead, matrix teams to ensure efficient implementation of all key deliverables for the diagnostic project.

• Supports regulatory interactions by contributing to the writing and the review of diagnostic portions of briefing documents, informed consents, clinical protocols, schedule of activities and clinical study reports,

• Where applicable, contributes to the implementation of strategies to manage risks on clinical study timelines, budgets and goals. Contributes to decisions which balance risk/benefit with clear understanding of impact on project.

• Builds and maintains networks with clinical study teams, regulatory, clinical and biomarker leads, project management, business operations and IVD partner joint project team members to ensure timely dissemination of information to appropriate levels to improve transparency.

• Provides frequent clinical study updates related to diagnostic project deliverables to management and to study level matrix teams, both internally and externally.

• Works with clinical, regulatory, operations, policy, BD and business unit colleagues and key leadership within project teams

We are looking for professionals with these required skills to achieve our goals:

• Advanced degree in Biological sciences;

  • Ph.D. with 3 or more years of pharmaceutical and/or IVD manufacturer experience or

  • M.S. with 5 years or more years of pharmaceutical and/or IVD manufacturer experience

• Experience in clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management

• Experience in clinical/translational biomarker investigation including biomarker operations and data management.

• Experience with IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements.

• Experience in technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies).

• Experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as MS Teams

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

• Experience in drug andDx co-development in oncology

• Experience in evaluating and auditing partners for clinical biomarker test execution.

• Familiarity with clinical laboratory and medical device requirements including: GCP/GCLP, CLIA, CAP, ISO15189, QSR regulations, GMP manufacturing, ISO13485, including FDA/US and EMA/EU.

• Knowledge of US and Ex-US testing and regulatory landscape, including evolving IVDR requirements in the EU. For example, pre-submission packets, SRD and IDE authoring and HDE/510k/PMA documentation) for class II and/or class III devices

• Able to manage multiple projects including assessment of workload and resourcing requirements to deliver the team's objectives.

• Detail oriented with strong organization skills.

• Exceptional written and verbal communication skills.

• Good track record working within a matrix team environment.

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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