Director, Oncology Translational Medicine

Job Purpose:

In this role, you will be responsible for the development and effective implementation of biomarker and translational medicine strategies to support the clinical development of late-stage oncology assets. As a key member of a Clinical Matrix Team (CMT), the Clinical Biomarker Director, will collaborate with the Clinical Biomarker Executive Director, to establish clear decision-making criteria, define patient segmentation strategies, and integrate these into clinical development plans. You will leverage cutting-edge technologies and methodologies to discover and clinically validate biomarkers, ensuring the biomarker strategy is fully aligned with the clinical plan. This integration will optimise decision-making in drug development and enable the identification of the right patient populations for our medicines.

This role will provide YOU with an opportunity to advance YOUR career, with responsibilities including:

• Collaborating closely with the Clinical Biomarker Executive Director to drive the design, alignment, and execution of clinical biomarker and translational medicine strategies focused on identifying predictive biomarkers that enable clinical success.
• Validating and implementing biomarker strategies, including target engagement, pharmacodynamic, and proof-of-mechanism biomarkers, for clinical-phase programs to support patient stratification, dose selection, and enable clinical go/no-go decisions.
• Participating in tumor-specific Biomarker Matrix teams, with responsibility for executing clinical biomarker strategies for late-stage oncology programs, while working closely with internal and external stakeholders, as well as disease area strategy teams.
• Representing Translational Medicine at Clinical Development Matrix Teams (CMT) to establish biomarker-driven decision-making criteria and their seamless integration into clinical study designs, aligning with clinical study objectives
• Supporting disease area strategies and translational objectives by defining biomarker priorities, areas of interest, and generating decision-enabling evidence packages informed by real-world datasets, internal and external data and partnerships (For e.g., research collaborations, KEE consultations).
• Identifying cutting-edge science and technological advances to incorporate into biomarker strategies for guiding indication selection, patient enrichment, and combination strategies.
• Overseeing and/or developing sample testing plans and delivering high-quality biomarker data packages to inform clinical development and regulatory strategies.
• Managing effective relationships with clinical and scientific operations, diagnostics, medical science, medical affairs, regulatory, portfolio management, and commercial functions.
• Supporting the expansion of mechanism and disease understanding to generate insights for indication expansion and scientific exchange as needed.
• Defining and studying mechanisms of resistance to enable reverse translation, inform next-line strategies, support patient enrichment, and influence life cycle management of assets.
• Contributing to the company’s scientific credibility through publications and presentations.

Why You?

Basic Qualifications:
We are looking for professionals with the following required skills and experience:

• Ph.D. or equivalent with minimal 7 years or M.Sc with minimum 10 years of drug development experience in the pharmaceutical industry, with a solid background in oncology clinical biomarkers, expertise in late-phase oncology studies- and translational research within clinical development.
• Strong expertise in cancer biology and clinical development, including the therapeutic landscape, approved and investigational agents, and diagnostic approaches in solid tumour and haematological malignancies.
• Experience leading cross-functional teams, designing and executing strategic biomarker plans including development of regulated biomarker assays.
• Experience conducting clinical trials and working as part of clinical study teams.
• Track record of designing and executing translational biomarker plans for clinical trials. Explores and onboards innovative technologies to advance translational research and new biomarker development
• Experience collaborating effectively with Data Sciences to analyse high-dimensional preclinical and clinical data to guide clinical decisions and inform asset strategy.
• Hands-on experience implementing a broad range of biomarker platforms such as flow cytometry, molecular diagnostics including NGS, FISH and PCR, IHC/IF, liquid biopsy / ctDNA approaches, and multi-omic biomarker analyses.
• Direct successful translation of pre-clinical research to human clinical trials, leveraging learnings from genomic, transcriptomic, and proteomic analyses of both preclinical models and patient samples.
• Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment

Preferred Qualifications:
The following qualifications would be advantageous:

• M.D., Ph.D. or equivalent doctoral degree in a relevant scientific discipline.
• Experience with high-dimensional dataset analysis.
• Prior experience with diagnostic development and regulatory interactions.
• Experience with digital pathology, AI/ML-enabled biomarker analyses, external scientific partnerships, and mentoring or developing scientific colleagues.
• Strong interpersonal skills and ability to thrive in a matrixed environment. Dependable and trustworthy, willing to take ownership and responsibility
• Demonstrated ability to influence teams and key leaders, with a track record of success.
• Excellent communication, problem-solving, matrix project-management, and presentation skills.

#LI-GSK*

#Hybrid*

Skills

Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations

 

 

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $189,750 to $316,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit  GSK US Benefits Summary 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.

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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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