Executive Director, Oncology MDT Biomarker Lead

Role Summary

Executive Director, Oncology MDT Biomarker Lead responsible for shaping and implementing clinical biomarker strategies to inform clinical development in collaboration with tumor-specific Medicine Development Teams (MDT). This matrix leadership role focuses on high-priority oncology programs, guiding translational medicine strategies and leading biomarker matrix teams to support individual trials.

Responsibilities

• Subject matter expert in solid tumor or hematological tumor biology, disease progression and treatment options; accountable for the strategic design and oversight of biomarker strategies across drug development programs.
• Lead asset and/or tumor-specific Biomarker Matrix teams to develop and execute clinical biomarker strategies for oncology programs with internal and external stakeholders.
• Provide input to clinical teams on biomarker-related elements of study trial design and conduct.
• Serve as the single point accountable for Clinical and Translational biomarker teams at the MDT; align biomarker strategy with TMP and lead MDT interactions, study teams, and Protocol Review Forum; represent MDTs at governance as needed.
• Manage budgets and resources to deliver biomarker strategies effectively.
• Work with Translational Research teams to align preclinical and clinical biomarker strategies.
• Partner with internal technology groups, CROs, and collaborators to deliver clinically validated biomarker assays into clinical studies.
• Collaborate with Diagnostic leads to implement diagnostic strategies for validation and regulatory approval of predictive biomarkers.
• Ensure alignment of biomarker outputs with data management, statistics, and modelling/simulation requirements.
• Support expansion of mechanism and disease understanding to generate insights for indication expansion and marketing when required.
• Enable matrix team deliverables by evaluating state-of-the-art platform technologies and incorporating innovative biomarkers into translational medicine plans.
• Collaborate with clinical biomarker labs, clinical pharmacology leads, and diagnostic leads, incorporating their input into clinical biomarker strategies.

Qualifications

• Required: PhD in Oncology, Clinical Biomarkers, or Translational Research.
• Required: Extensive (greater than 15 years) experience in Oncology clinical biomarkers and translational research within clinical development.
• Required: Experience in leading cross-functional teams and delivering strategic biomarker plans.
• Required: Experience in interpreting clinical biomarker data and assessing innovative platforms and technologies for use in clinical trials.
• Required: Experience in senior stakeholder engagement supporting decision-making in drug development.
• Preferred: Experience in global matrix leadership across multiple locations.
• Preferred: Familiarity with regulatory processes for diagnostics and predictive biomarkers.
• Preferred: Ability to anticipate future challenges and innovate solutions in biomarker strategies.
• Preferred: Excellent communication, problem solving, and influencing skills.

Education

• PhD in Oncology, Clinical Biomarkers, or Translational Research.