GSK is committed to improving lives through innovative science and transformative medicines. As the Executive Director, ADC tumor 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.
Key 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 of tumor-specific ADC 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 tumour-specific 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 companion 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 ADC 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.
Why You?
Basic Qualifications
* PhD in Oncology, Clinical Biomarkers, or Translational Research.
* Extensive (>15 years) experience in Oncology clinical biomarkers and translational research within clinical development.
* Experience in leading cross-functional teams and delivering strategic biomarker plans.
* Experience in interpreting clinical biomarker data and assessing innovative platforms and cutting-edge biomarker technologies and their application in clinical trials.
* Experience in senior stakeholder engagement supporting decision-making in drug development.
Preferred Qualifications
* Experience in global matrix leadership across multiple locations.
* Familiarity with regulatory processes for companion diagnostics and predictive biomarkers.
* Ability to anticipate future challenges and innovate solutions in biomarker strategies.
* Excellent communication, problem solving, and influencing skills.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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