What are the responsibilities and job description for the Senior Director Clinical Research position at Circular Genomics?
Circular Genomics (CG), Inc. is a venture-backed cutting-edge biotechnology company dedicated to harnessing the power of brain-derived circular RNA-based technologies to revolutionize prediction and treatment for depression, Alzheimer's and other psychiatric and neurological disorders. With a focus on precision medicine, we are committed to transforming lives through groundbreaking research, clinical innovation, and strategic collaborations.
Circular Genomics seeks a Sr. Director, Clinical Research to join a rapidly growing team. This leader will oversee the clinical research strategy in designing and monitoring prospective clinical utility and retrospective R&D studies that validate the performance of the Company’s diagnostic and therapeutic circular RNA-based genomic assays for depression and Alzheimer’s disease. Candidates should have extensive experience in clinical research, study construction, sample management, and clinical data management for LDT clinical trials, and experience with regulatory coordination. Previous experience in clinical study development, and psychiatric or neurological clinical or translational research is highly valued. The Sr. Director of Clinical Research will play an active role in supporting Circular Genomics’ health economics and clinical utility research through the maintenance and evolution of existing systems and processes involved in the collection, review, and analysis of clinical data. The Sr. Director of Clinical Research role requires statistical and operational and grant writing expertise with a proven ability to thrive in an early-stage company.
RESPONSIBILITIES
- Design protocols, coordinate, and monitor clinical trials, studies, and samples including coordination with study monitor, identification of and communication with study sites, and analysis of study data.
- Conceive, implement, and lead validation trials and core studies for LDT products to meet requirements of FDA, CLIA, CMS, and payers; support publication efforts on data and related grant writing efforts.
- Benchmark, plan, and build forward-looking clinical infrastructure including : IT, biorepository, compliance, vendors, collaborators, etc.
- Participate in strategic planning for future clinical studies and testing pipelines.
- Recruit, hire, and train new staff; work collaboratively with and provide direction to consultants.
- Collaborate with R&D / laboratory teams to support test development, operationalization, and optimization as well as to ensure data quality and completion of LDT data sets.
- Build and maintain strategic collaborations with industry, healthcare, and academic partners to advance the company’s mission.
- Interface with KOLs on clinical research projects and validation studies; manage, synthesize and incorporate expertise / feedback from KOLs, advisors, and clients.
- Partner effectively with key stakeholders in senior management including R&D and commercial teams to execute a sound clinical strategy.
REQUIREMENTS
Circular Genomics Inc. is committed to a diverse and inclusive workplace. Circular Genomics Inc. is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please email info@circulargenomics.com.
