Associate Director- Diagnostics Precision Medicine

About the role

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 team, you will contribute to the implementation of GSK diagnostic strategies supporting drug development, including technical, clinical, regulatory, commercial, intellectual property and business development components. You will lead diagnostic projects and workstreams according to agreed deliverables, timelines and budget, within a matrix cross-functional environment.

Responsibilities

• Support development of end-to-end diagnostic strategy across early and late-stage clinical studies aligned with biomarker and clinical development plans.
• Accountable for tactical execution with external partners to develop, validate and implement diagnostic tests for clinical studies.
• Oversee technical development, validation and implementation of diagnostic assays within a clinical trial.
• Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements.
• Manage and deliver projects/workstreams within agreed timelines and budgets.
• Work within, and may lead, matrix teams to ensure efficient implementation of all key deliverables for diagnostic projects.
• Contribute to the implementation of strategies to manage risks on clinical study timelines, budgets and goals.
• Build and maintain networks with regulatory, clinical and biomarker leads, clinical study teams, project management, business operations, and IVD partner joint project team members to coordinate activities and ensure timely dissemination of information.

Qualifications

• PhD with 3+ years OR MS with 5+ years of experience in pharmaceutical or IVD development.
• Experience in clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management, and human biological specimen management.
• Experience in 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).

Preferred Qualifications

• Experience in drug-diagnostic co-development in oncology.
• Experience in evaluating and auditing partners for clinical biomarker test execution.
• Familiarity with clinical laboratory and medical device requirements in the US and EU including: GCP/GCLP, CAP/CLIA, ISO15189, ISO13485, etc.
• Knowledge of US and Ex-US diagnostic testing and regulatory landscape, including evolving IVDR requirements in the EU, QSR regulations, and GMP manufacturing.
• Experience authoring and reviewing regulatory documents including pre-submission packets, SRD, IDE, HDE and ODD applications, 510(k) and PMA submissions for Class II and Class III devices.
• Able to manage multiple projects including assessment of bandwidth and resourcing requirements to deliver the team’s objectives.
• Track record of success working within a matrix team environment.
• Detail oriented with strong organization skills.
• Exceptional written and verbal communication skills.
• Proficiency with MS Office and collaboration tools such as Teams.

Pay

The annual base salary for new hires in this position ranges $150,975 to $251,625. 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.

Schedule

This position is hybrid. You will combine remote work with time in the office for team collaboration and critical meetings. Specific on-site expectations will be discussed during the interview process.