Department: Clinical Development
Reports to: Director of Clinical Development
Biotheranostics, Inc. is seeking a talented and results-driven clinical or translational scientist to join our team in San Diego, CA (see www.biotheranostics.com). This position offers an excellent opportunity for a highly motivated person to lead and support the clinical development program of molecular diagnostic tests. We are seeking a well-trained scientist/clinician who is driven by science and the desire to improve cancer patients lives. Works closely with Research and Development, Biostatistics, and Medical Affairs
Essential Duties and Responsibilities:
- Execute clinical strategy to validate and establish the clinical utility of biomarkers and molecular diagnostic tests in oncology.
- Lead the development of clinical study protocols in conjunction with research & discovery and biostatistics teams and recruit investigators.
- Manage clinical studies and serve as primary liaison with external collaborators, clinical investigators, and medical experts to ensure protocol execution and study conduct that is consistent with research objectives and endpoints.
- Participate on cross-functional teams to provide scientific support and functional representation.
- Support writing of clinical study reports; provide scientific/medical input and assist in the writing and review of scientific and regulatory submissions; prepare and present clinical data at external scientific/board meetings as needed.
- Ensure strategic assessment of clinical programs align and support product life-cycle plan and provide strategic input for future studies.
- Partner with Medical Affairs for organization of meetings and conferences and support execution of publication strategy.
- Assist in establishing study budgets and Standard Operating Procedures.
- Ideal candidate will have a M.D. or PhD in a biomedical field with at least 3-5 years of industry experience in clinical research and a background in molecular biology.
- Record of clinical research in the development and validation of biomarkers, ideally in the field of oncology
- Familiarity with pathology and oncology, and genomic approaches in diagnostic applications and biomarker discovery a plus
- A track record of scientific productivity (publications, patents)
- Demonstrated technical and project management capabilities are required, as well as effective verbal and written communication skills in a collaborative work environment.
- Highly adaptable to functioning in a fast-paced environment.
- Self-motivated and passion for medical innovation and commitment to scientific rigor.
If interested, please submit a copy of your CV/Resume to us to apply.E-mail