Executive Director, Oncology MDT Biomarker Lead

Role Summary

Executive Director, MDT Biomarker Lead responsible for shaping and implementing clinical biomarker strategies to inform clinical development in oncology, leading matrix teams of biomarker experts and aligning translational medicine strategies with Oncology MDTs.

Responsibilities

• Subject matter expert in solid tumor or hematological tumor biology, accountable for strategic design and oversight of biomarker strategies for drug development programs.
• Lead asset and tumor-specific Biomarker Matrix teams to develop and execute clinical biomarker strategies for oncology programs in collaboration with internal and external stakeholders.
• Provide input to clinical teams on biomarker-related elements of study design and conduct.
• Serve as the single point accountable for Clinical and Translational biomarker teams at the MDT; align biomarker strategy with TMP and represent MDTs at governance forums as needed.
• Manage budgets and resources to deliver biomarker strategies effectively.
• Coordinate with Translational Research teams to ensure alignment of 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 requirements.
• Support expansion of mechanism and disease understanding to enable indication expansion and marketing insights.
• 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 to incorporate their input into clinical biomarker strategies.

Qualifications

• Required: PhD in Oncology, Clinical Biomarkers, or Translational Research.
• Required: Extensive (>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 cutting-edge biomarker 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.