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About the Role
The Senior Director, Clinical Data Management will lead the Clinical Data Management function, ensuring high-quality, timely, and regulatory-compliant clinical data across development programs. This role provides strategic and operational leadership, focusing on effective oversight of CROs and external vendors, and establishing data management processes and standards for late-stage development and regulatory submission. It requires both strategic oversight and hands-on leadership, including serving as the study Data Management Lead when needed.
Responsibilities
- 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.
- Oversee the integration and reconciliation of external data, including central laboratory, PK/PD, IRT, eCOA, imaging, and safety data.
- Establish and maintain data management standards, SOPs, processes, templates, and best practices across studies and programs.
- Partner with Clinical Operations, Medical, Biostatistics, Statistical Programming, Pharmacovigilance, and other functions to ensure timely and high-quality clinical data.
- Ensure clinical data collection and management processes support CDISC standards, downstream statistical analyses, and regulatory submission requirements.
- Establish data quality metrics and proactively identify and resolve data quality, operational, and timeline risks.
- Ensure clinical data management activities and documentation are compliant with GCP, applicable regulatory requirements, and inspection-ready.
- Support regulatory submissions, regulatory authority responses, audits, and inspections related to clinical data.
- Evaluate and implement fit-for-purpose systems, tools, automation, and data review approaches to improve data quality and operational efficiency.
- Build and develop the Clinical Data Management function, including resource planning, vendor strategy, and management and mentoring of internal staff and consultants.
Requirements
- Bachelor’s degree in life sciences, health sciences, computer science, or a related field; advanced degree preferred.
- 15 + years of progressive clinical data management experience in the biotechnology, pharmaceutical, and/or CRO industry.
- Significant experience leading data management activities for Phase 2 and Phase 3 clinical trials, preferably in a sponsor environment.
- Demonstrated experience serving as a study Data Management Lead, with hands-on responsibility from study start-up through database lock.
- Experience leading or providing oversight of CROs and external data management vendors, including management of quality, timelines, and deliverables.
- Strong experience with EDC systems, preferably Medidata Rave, and with eCRF design, database development, edit checks, data cleaning, external data reconciliation, and database lock.
- Strong knowledge of GCP, regulatory requirements, and clinical data management standards and best practices.
- Working knowledge of CDISC/SDTM and understanding of how clinical data collection and database design affect downstream statistical analyses and regulatory submissions.
- Experience with MedDRA and WHODrug coding and management of external data such as central laboratory, PK/PD, eCOA, IRT, and safety data.
- Experience supporting late-stage development, regulatory submissions, audits, and regulatory inspections is highly desirable.
- Demonstrated ability to develop and implement data management SOPs, standards, processes, and governance.
- Strong leadership, vendor-management, communication, and cross-functional collaboration skills, with the ability to operate both strategically and hands-on in a growing biotech environment.
Skills
- Clinical Data Management
- EDC systems
- Medidata Rave
- eCRF design
- Database development
- Edit checks
- Data cleaning
- External data reconciliation
- Database lock
- GCP
- Regulatory requirements
- Clinical data management standards
- Best practices
- CDISC/SDTM
- MedDRA
- WHODrug coding
- Central laboratory data management
- PK/PD data management
- eCOA data management
- IRT data management
- Safety data management
- SOP development
- Process development
- Governance implementation
- Leadership
- Vendor management
- Communication
- Cross-functional collaboration
- Strategic thinking
- Hands-on execution
Location
- South San Francisco
Work Type
- Full-time
- On-site (at least three days per week)
Experience Level
- Senior Director
- Executive Director
- 15+ years of progressive clinical data management experience
- Significant experience leading data management activities for Phase 2 and Phase 3 clinical trials
- Demonstrated experience serving as a study Data Management Lead
Education Level
- Bachelor’s degree in life sciences, health sciences, computer science, or a related field
- Advanced degree preferred
Salary/Compensations
- $250,000 - $300,000
About the Company
- 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.
- Their 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).
- MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 development.
- Their second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in acromegaly.
- MAR002 has potential to become best-in-disease and is quickly progressing into Phase 2/3 clinical development.
- They also have a third asset that is swiftly advancing through research discovery, with DC nomination expected this year.
- At Marea, they believe in the power of collaboration and the importance of leading by example.
- They are a tight-knit team that values the contributions of every member.
- Their environment is dynamic, with each day presenting new challenges and opportunities for growth.
- Every role is “Hands-On”, and the successful candidate will be able to work alongside team members to understand challenges and drive results.
Equal Opportunity
- We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law.
- We invite applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.