Key Responsibilities
- Build and maintain biomarker plan
- Implement biomarker plan as part of the clinical synopsis and clinical protocol
- Design, execution and analysis of clinical biomarkers of target engagement, safety, pharmacodynamics, and efficacy.
- Manage outsourced biomarkers assays at external vendors
- Coordinates between CRO assay development group and clinical team, when necessary
Minimum Requirements/ Qualifications
- Ph.D. with 5+ years Biotechnology industry experience or Master’s degree with 10+ years Biotechnology industry experience
- Proven track record of high-impact contributions to clinical trial biomarkers and endpoints, and regulated assay development and validation in support of early and late phase clinical trials
- Experience with, at a minimum, enzyme activity assays, LC-MS based biomarker assays, and vector copy number (VCN) assays in a regulated setting.
- Experience with authoring and reviewing SOPs and Validation documents in support of a regulatory filing or review.
- Having a 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 matrix environment
- Experience in managing external collaborations, contract laboratories and timelines and budgets.
- Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
- Effective verbal and written communication skills relating to colleagues and associates both inside and outside the corporation.
- Flexibility to work on multiple projects as the portfolio evolves over time.