We are seeking a motivated and experienced Biomarker Lead to join our energetic and high-growth translational team. The Biomarker Lead will report directly to the Senior Director of Translational Science. Responsibilities include planning, developing, implementing, troubleshooting, and executing clinical biomarker strategies in clinical trials, as well as supporting asset prioritization and conducting translational studies if needed. This position will work closely with preclinical and clinical teams to ensure clinical biomarker strategies follow the science to best improve future therapies for the benefit of patients. The Biomarker Lead will identify, design biomarker plans, and work with Contract Research Organizations to ensure the biomarker strategy/plan is properly developed, implemented, and executed. This role will also be responsible for biomarker outputs, document organization, data management, data interpretation, data presentation, and contributing to document writing and clinical decision-making.
Essential Duties & Responsibilities:
Provide scientific input to clinical teams on biomarker-related elements of study trial design and conduct, including the incorporation of biomarkers into clinical protocols, Informed Consent documents, Investigator Brochures, Study Reference Manuals, and Central Lab Worksheets.
Work with internal teams, Contract Research Organizations, and external collaborators to develop, troubleshoot, validate, and implement translational biomarker assays for clinical studies.
Liaise with other parts of the organization to implement learnings and resolve study biomarker questions.
Develop and maintain project clinical biomarker strategies, including approaches to pharmacodynamic and predictive biomarkers.
Develop companion diagnostic strategies for validation, implementation, and regulatory approval of predictive biomarkers.
Support the expansion of understanding the mechanism of action of investigated drug products in specific disease indications to facilitate go/no-go decision-making for future pipeline assets.
Willing to support translational projects by designing and conducting wet lab experiments to enhance understanding of the mechanism of action for drug products and meet regulatory requirements if necessary.
Evaluate the value and suitability of new technologies for potential use in identifying pharmacodynamic and predictive biomarkers in clinical trials.
Contribute to the evaluation and management of biomarker vendors by providing scientific and technical expertise in biomarker assays.
Preferred Experience & Abilities:
Expertise in the planning, discovery, validation, and clinical implementation of biomarkers.
Prior experience in one specific research area and/or biomarker technology (flow cytometry, molecular assay, sequencing, secretome) is preferred.
Hands-on experience working with CROs is required.
Knowledge and track record of working to GCP principles.
Strong communication, organization, and record-keeping skills are required.
High emotional intelligence demonstrated by the ability to positively influence teams and key stakeholders with a proven track record of success.
Proven organizational and project management skills and the ability to manage cross-functional efforts.
Understanding of clinical trial design, overall principles of clinical development, and related disciplines (e.g., gene-engineered cell therapy, clinical pharmacology, toxicology, immunology, biology, formulation, and drug product).
Qualification Requirements:
Bachelor's degree with a minimum of 5 years of industry experience, Master's Degree with a minimum of 3 years of industry experience, or PhD with a minimum of 2 years of industry experience.
Masters or PhD preferred.
Minimum of 2 years of experience in clinical biomarkers.
Cell therapy experience preferred.
Strong professionalism, written, and verbal communication skills.