Senior Director, Biomarker Science Leader

Alternative Resources Company

Senior Director, Biomarker Science Leader

Senior Director, Biomarker Science Leader
 
The Biomarker Science Leader will be responsible for executing clinical translational strategies. This individual will work across all phases of drug development with both internal and external parties to determine how best to guide therapies to the subjects most likely to benefit from them.
 
Responsibilities
  • Identify and utilize existing and emerging tools to facilitate the translation of preclinical results to clinical audiences. This will include overseeing the design of preclinical and clinical studies to acquire relevant data from both internal and external commercial and academic sources.
  • Develop and implement specific strategies for each developmental project.
  • Research, author and implement clinical protocol specific biomarker objectives and goals, including logistical execution of activities specified in clinical protocols. This includes participation in clinical protocol drafting and finalization, study start up activities, sample planning and management, oversight of assay validation and execution, and analysis and interpretation of results. Specific activities may include (but are not limited to) authoring and checking the accuracy of the biomarker portion of protocols, investigator brochures, informed consent, statistical analysis plans, lab sample requirements / lab manuals, data management and transfer plans, interim analyses, and clinical study reports.
  • Curate and integrate datasets (biomarker results, sample characteristics, clinical outcome) to facilitate PK/PD analyses.
  • Serve as primary biomarker related contact with vendors and CROs to ensure success for any outsourced elements of the strategy.
 
Qualifications
  • MD, PhD, or equivalent advanced degree.
  • Experienced scientist with 5+ years of experience in pharmaceutical drug development.
  • Accomplished ability to solve problems creatively.
  • Demonstrated ability to work in a matrix environment and multitask across multiple development projects in a fast-paced environment.
  • Demonstrated flexibility to support the unique needs of each project and team.
  • Knowledge of Oncology, Neuroscience, Ophthalmology and Dermatology beneficial.
  • Demonstrated data analysis skills including experience with bioinformatics software tools.
  • Significant understanding of all functional areas of drug development, including, biology, toxicology, clinical development, data management and diagnostic development strongly preferred.