1925 GlaxoSmithKline LLC
Executive Director, ADC tumor MDT Biomarker Lead
1925 GlaxoSmithKline LLC, Waltham, Massachusetts, United States, 02254
Overview
Executive Director, ADC tumor MDT Biomarker Lead Job Purpose At GSK, we are 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 focuses 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 teams of Clinical Biomarker experts supporting individual trials, this role will drive the creation and alignment of translational medicine strategies in support of ADC tumor-specific MDTs. 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 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 Hybrid Please visit to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. 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. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas : respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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. Important notice to Employment businesses / Agencies GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site. All employment businesses / agencies are required to contact GSK\'s commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
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Executive Director, ADC tumor MDT Biomarker Lead Job Purpose At GSK, we are 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 focuses 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 teams of Clinical Biomarker experts supporting individual trials, this role will drive the creation and alignment of translational medicine strategies in support of ADC tumor-specific MDTs. 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 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 Hybrid Please visit to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. 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. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas : respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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. Important notice to Employment businesses / Agencies GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site. All employment businesses / agencies are required to contact GSK\'s commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
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