Director, Oncology Translational Medicine, Clinical Biomarkers

Job Purpose

The Director, Oncology Translational Medicine, Clinical Biomarkers is 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.

Key Responsibilities

• 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.

Basic Qualifications

• Ph.D. or equivalent with 7+ years or M.Sc. with 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 tumor and haematological malignancies.
• Experience in leading cross-functional teams and designing and executing strategic biomarker plans including development of regulated biomarker assays.
• Experience conducting clinical trials and working as part of clinical study teams.
• Experience 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 analyze 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.
• Experience influencing teams and key leaders, with a track record of success.

Preferred Qualifications

• 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 sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment.
• Strong interpersonal skills and ability to thrive in a matrixed environment.
• Dependable and trustworthy, willing to take ownership and responsibility.
• Excellent communication, problem-solving, matrix project-management, and presentation skills.