Executive Director, Oncology MDT Biomarker Lead

Role Summary

At GSK, we are committed to improving lives through innovative science and transformative medicines. As the Executive Director, MDT Biomarker Lead, you will play a pivotal role in shaping and implementing clinical biomarker strategies that inform clinical development and decision-making in collaboration with tumor-specific Medicine Development Teams (MDT).

This matrix leadership role allows focus on high priority program(s) within the Oncology portfolio and requires extensive experience in the application of clinical biomarkers and translational research within clinical development with the goal to inform right dose, right patient, right drug at the right time. While leading matrix team(s) of Clinical Biomarker experts supporting individual trials, this role will drive the creation and alignment of translational medicine strategies in support of Oncology MDTs.

Responsibilities

• Subject matter expert in solid tumor or haematological tumor biology, disease progression and treatment options; accountable for the strategic design and oversight of implementation of Biomarker strategies associated with disease modalities related to drug development programs.
• Leading asset and / or tumor-specific Biomarker Matrix teams to develop and execute clinical biomarker strategies for oncology programs in collaboration with internal and external stakeholders and with input from disease area teams.
• Providing input to clinical teams on biomarker-related elements of study trial design and conduct.
• Single point accountable person for Clinical and Translational biomarker team at the MDT. Aligns biomarker strategy with TMP and leads interactions at the MDT(s), study teams and Protocol Review Forum; representing the MDTs at governance where needed.
• Managing budgets and resources to deliver biomarker strategies effectively.
• Working with Translational Research teams to ensure alignment of preclinical and clinical biomarker strategies.
• Partnering with internal technology groups, Contract Research Organisations and collaborators to deliver clinically validated biomarker assays into clinical studies.
• Collaborating with Diagnostic leads to implement diagnostic strategies for validation, and regulatory approval of predictive biomarkers.
• Ensuring alignment of biomarker outputs with data management, statistics, and modelling/simulation requirements.
• As required, supporting the expansion of mechanism and disease understanding to generate insights that can be leveraged in indication expansion and marketing.
• Enabling matrix team deliverables by ensuring the appropriate evaluation of state-of-the art platform technologies and incorporating innovative biomarkers into translational medicine plans.
• Responsible for collaboration with clinical biomarker labs, clinical pharmacology leads and diagnostic lead and incorporating 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 and their application 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.