The Next Frontier of Medicines for Cardioendocrine Diseases. Backed by Third Rock Ventures.
About the role
Reporting to the Vice President, Biostatistics, the SD/ED of Clinical Data Management will lead the Clinical Data Management function and be responsible for ensuring high-quality, timely, and regulatory-compliant clinical data across the company’s development programs. This individual will provide strategic and operational leadership for clinical data management activities, with a particular focus on effective oversight of CROs and other external vendors.
What they're looking for
- Lead the Clinical Data Management function and provide strategic and operational direction across clinical development programs
- Provide hands-on study-level data management support and serve as the Data Management Lead for individual studies when needed
- Oversee clinical data management activities throughout the study lifecycle, from study start-up through database lock and archival
- Provide sponsor oversight of CROs and external data management vendors, ensuring quality, timelines, and deliverables meet company expectations
- Oversee the development and maintenance of eCRFs, clinical databases, Data Management Plans, edit checks, and data review processes
- Lead data cleaning, query management, medical coding, reconciliation, and database lock activities
More about this role
Marea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.
The company’s lead program, MAR001, is being developed for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels and elevated risk of acute pancreatitis. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is quickly progressing into Phase 2/3 clinical development. We also have a third asset that is swiftly advancing through research discovery, with DC...
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