Associate Director, Biomarkers

Role Summary

Associate Director, Biomarkers responsible for leading development of biomarker strategies for clinical trials, integrating biomarker approaches into clinical development plans, and serving as a biomarker lead on clinical matrix teams (CMT).

Responsibilities

• Work with external industry and/or academic partners to evaluate, validate and establish biomarker capabilities and generate biomarker data to support strategies for clinical trial implementation.
• Design, implement, and manage collaborative projects to develop biomarker capabilities of strategic importance to the program and in alignment with clinical trials.
• Identify, develop, and implement advances in science and technology into biomarker strategies to guide indication selection, patient enrichment, and combination strategies.
• Provide input to clinical biomarker teams on novel technologies enabling clinical development of candidate drugs.
• Manage relationships with clinical biomarker leads, medical affairs, oncology teams, portfolio management, competitive intelligence, clinical development and management teams.
• Contribute to and ensure quality of biomarker reports, summaries, data reviews and interpretations; present data at internal and external scientific forums; lead preparation/publication of manuscripts as needed.

Qualifications

• Ph.D. in Biological Sciences or related field with 2+ years of experience, or
• M.Sc with 5+ years of experience in biotechnology or pharmaceutical industry in biomarker applications in clinical trials.
• Knowledge of biomarker assays, technologies and platforms and their application in clinical research.
• Experience in biomarker discovery/development in a clinical setting.
• Experience in matrixed, multidisciplinary team environments.
• Demonstrated scientific expertise evidenced by publications, presentations, or internal/external reports.

Preferred Experience

• Knowledge of GCP/GLP principles.
• Strong prioritization, planning, and timely execution in fast-paced environments.
• Strong interpersonal skills and ability to thrive in a matrix environment.
• Dependable and trustworthy with ownership and responsibility.
• Experience conducting biomarker analyses on various clinical sample types as part of a clinical study team.

Education

• Not specified