Director, Precision Diagnostics in Oncology

Glaxosmithkline; Upper Providence (Delaware County); Hybrid; USD 190,000 - 316,000; Full time

Benefits offered by this job

Annual bonus

Health care and other insurance

Retirement benefits

Paid holidays

Vacation

Paid caregiver/parental and medical-le

Job summary

GlaxoSmithKline is seeking a Diagnostic Director for Precision Diagnostics Oncology to lead diagnostic development across programs, partnering with research, clinical development, regulatory, and commercial groups. You will shape diagnostic strategies aligned with oncology development needs and deliver impactful solutions to treat the right patient with the right medicine.

You will drive biomarker strategies, oversee budgets and timelines, and collaborate with external partners to accelerate

Qualifications

• Bachelor's degree in life sciences or related field; oncology experience preferred.
• 6+ years in diagnostic development, with oncology experience preferred.
• Experience integrating diagnostics into clinical trial design and regulatory submissions.
• Knowledge of regulatory requirements for diagnostics or companion diagnostics (FDA, EU IVDR, PMDA/MHLW Japan, etc).
• Protocol, informed consent and analysis plan development required to support diagnostic development and regulatory submissions.
• Proven ability to manage cross-functional projects, timelines, and budgets in a matrix environment.
• Strong stakeholder management skills, including working with clinical teams, external partners and clinical laboratories.

Responsibilities

• Execute precision diagnostics strategy for oncology programs across assets and therapeutic areas.
• Define diagnostic requirements for trials and implement biomarker selection, assay validation, and sample handling strategy.
• Oversee project plans, budgets, and timelines to ensure on-time, high-quality delivery of milestones.
• Collaborate with regulatory and quality teams to meet regulatory expectations and submissions.
• Engage external partners to accelerate assay development and access to patient samples.
• Provide frequent project status updates to the Diagnostic Subteam and leadership.
• Share learnings and drive cross-functional process improvements.

Skills

Analytical thinking

Clinical data interpretation

Clinical data review

Clinical development

Clinical trial designs

Clinical trials monitoring

Digital fluency

Drug regulatory affairs

Executive presence

Hematology and Oncology

Learning agility

Matrix leadership

Real World Evidence (RWE)

Scientific presentations

Education

Bachelor's degree in life sciences or related field

Advanced degree (MS, PhD, MD) in a relevant discipline

Job description

GlaxoSmithKline is seeking a Diagnostic Director for Precision Diagnostics Oncology to lead diagnostic development across programs, partnering with research, clinical development, regulatory, and commercial groups. You will shape diagnostic strategies aligned with oncology development needs and deliver impactful solutions to treat the right patient with the right medicine.

You will drive biomarker strategies, oversee budgets and timelines, and collaborate with external partners to accelerate