Role Summary
Director, Clinical Biomarkers, Oncology — lead development and implementation of biomarker and translational medicine strategies to support late-stage oncology assets. Collaborate within Clinical Matrix Teams to define decision-making criteria, patient segmentation, and integrate biomarker plans into clinical development. Drive biomarker discovery, validation, and alignment with clinical plans to optimize drug development decisions and patient population identification.
Responsibilities
- Collaborate with the Clinical Biomarker Executive Director to drive design, alignment, and execution of biomarker and translational medicine strategies aimed at identifying predictive biomarkers for clinical success.
- Validate and implement biomarker strategies (target engagement, pharmacodynamic, proof-of-mechanism) for clinical-phase programs to support patient stratification, dose selection, and go/no-go decisions.
- Participate in tumor-specific Biomarker Matrix teams and execute clinical biomarker strategies for late-stage oncology programs, coordinating with internal/external stakeholders.
- Represent Translational Medicine at Clinical Development Matrix Teams to establish biomarker-driven decision-making criteria integrated into study designs.
- Identify cutting-edge science and technologies to incorporate into biomarker strategies for indication selection and patient enrichment.
- Oversee or develop sample testing plans and deliver high-quality biomarker data packages to inform development and regulatory strategies.
- Manage relationships with clinical/scientific operations, diagnostics, medical science, medical affairs, regulatory, portfolio management, and commercial functions.
- Support expansion of mechanism and disease understanding to inform indication expansion and scientific exchange as needed.
- Contribute to scientific credibility through publications and presentations.
Qualifications
- Minimum of 5 years of pharmaceutical industry experience with strong oncology clinical biomarkers expertise (late-phase oncology studies) and translational research within clinical development.
- Background as a Scientist and/or Physician.
- Proven ability to lead cross-functional teams and execute strategic biomarker plans.
- Experience conducting clinical trials and working as part of clinical study teams.
- Expertise in interpreting clinical biomarker data and evaluating innovative biomarker technologies for clinical trial applications.
- Strong interpersonal skills and ability to thrive in a team-oriented environment.
- Demonstrated ability to influence teams and key leaders with a track record of success.
Preferred Qualifications
- Experience with high-dimensional dataset analysis.
- Expertise in identifying predictive biomarkers and/or diagnostic development.
- Excellent communication, problem-solving, and presentation skills.
Location
On-site presence 2 to 3 days a week in the UK (Stevenage) or US (Upper Providence, PA; Waltham, MA).