Location: Cambridge, MA
The Head of Biomarker and Diagnostics will drive the scientific and technical development, implementation and clinical validation of biomarkers and diagnostic tools, in parallel to drug development. S/he will develop forward-looking biomarker and diagnostic development strategy with a profound understanding of competitive landscape and regulatory updates in the external environment. The department head will be fully accountable for the execution of the biomarker plan and the successful implementation of internal and external biomarker activities to support clinical studies.
Principal Duties and Responsibilities
- Work with the H3 leadership team to establish the biomarker and diagnostics strategy to ensure appropriate development and inclusion of clinical biomarkers in clinical studies, incorporating deep understanding of internal projects, and technology development, competitive landscape and regulatory updates in the external environment
- Capability and partnership development
- Drive the scientific and technical development, implementation and clinical validation of biomarkers and diagnostic tools, in parallel to drug development as appropriate.
- Lead diagnostics partner evaluation and selection activities and manages multiple diagnostics partnerships with CROs to ensure validation of clinical biomarker assays prior to implementation
- Be fully accountable for the execution of the biomarker plan and the successful implementation of internal and external biomarker activities to support clinical studies
- Provide scientific and technical leadership and expertise by collaborating closely across departments to ensure successful implementation of biomarker and companion diagnostics strategy across clinical development projects.
- Guide analysis, interpretation and presentation of results from biomarker analyses and draw scientifically valid conclusions that support and enable decision making
- Support regulatory affairs in providing content and providing review of documents supporting companion diagnostics submissions to the FDA and other health authorities globally
- Team development and management
- Build, develop and directly supervise biomarker and clinical diagnostics team members.
- Must be passionate about coaching and mentoring.
- Represent biomarker and diagnostics related aspects internally and externally.
- MD and/or PhD in Life Sciences
- Minimum 10 years’ of experience in oncology pharmaceutical or diagnostics industry
- Demonstrated track record of success working on multidisciplinary drug development teams in pharmaceutical / biotechnology environment
- Strong strategic leadership skills with a proven ability to define, prioritize and balance responsibilities in accordance with company’s research, development and business needs
- Previous line management experience and experience working with CROs
- Broad Knowledge of drug development process and a strong understanding of the roles of biomarker discovery and diagnostic development in oncology drug discovery, development and commercialization
- Knowledge and understanding of novel biomarker discovery and diagnostic assay technologies
- Ability to work in a highly collaborative environment globally with stakeholders from multiple functional areas
- Excellent interpersonal and written communication skills with the ability to effectively communicate with individuals at all levels internally and externally.
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.Submit Your Résumé