Ventus Therapeutics · 4 months ago
Senior Director, Clinical Data Management
Waltham, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
10+ years expVentus Therapeutics is a clinical-stage biopharmaceutical company focused on innovative small-molecule programs for immunology, inflammation, and neurology. The Senior Director, Clinical Data Management will establish and lead the CDM function, overseeing data management activities and ensuring compliance while fostering a collaborative team culture.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Lead the development and execution of data management processes and infrastructure as the first hire in the CDM function
Provide hands-on leadership for all study-level data management activities, recruiting, mentoring and guiding team members to ensure alignment with study goals and timelines
Establish a collaborative, growth-oriented culture within the CDM team
Collaborate with leadership, Clinical Operations, Biostatistics, Medical, and Pharmacovigilance functions, to align clinical data management activities with corporate milestones and resource capacity, ensuring smooth scaling of the function as company evolves
Partner with Biostatistics and IT to build and maintain essential clinical data management infrastructure in stages to ensure scalability and efficiency for clinical trials
Design and implement a fit-for-purpose clinical data review process, including developing essential tools to ensure data integrity and quality
Oversee the full lifecycle of clinical data management activities for clinical studies, including eCRF development, data collection, external data transfers, query generation, and data cleaning
Ensure that data is collected, cleaned, and validated in accordance with study protocols, timelines, and quality standards
Perform routine data reviews to identify discrepancies, inconsistencies, and data quality issues, ensuring timely resolution of queries to maintain data integrity throughout the clinical trial
Oversee the creation, review, and management of study-level documentation, including Data Management Plans, CRF completion guidelines, and external data transfer specifications
Serve as the key point of contact for internal teams, ensuring effective communication of data management requirements, timelines, and deliverables. Regularly update stakeholders on study data progress and key milestones
Ensure all data management activities comply with GCP, ICH, 21 CFR Part 11, and other relevant regulatory standards
Support regulatory submissions and inspections, providing necessary documentation and data for audits
Qualification
Required
Education: BA/BS in life sciences or a related field
Experience: At least 10+ years of clinical data management experience, with at least 5+ years in managerial role in within a pharmaceutical/biotech company or CRO
Therapeutic Areas: Experience in neurology, rheumatology, immunology & inflammation is a plus
Technical Expertise: Extensive experience with multiple EDC systems and knowledge of SAS/statistical programs for data analysis and visualization tools (e.g., Spotfire)
Leadership & Mentorship: Proven ability to lead and mentor a team, fostering a culture of continuous improvement and high performance
Regulatory Knowledge: Strong understanding of clinical research regulations (GCP, ICH, 21 CFR Part 11), CDASH/CDISC standards, and experience supporting regulatory submissions and inspections
Communication: Excellent interpersonal, organizational, and communication skills with a proven ability to maintain professional relationships and effectively convey complex data management concepts
Problem-Solving: Ability to anticipate challenges and proactively develop solutions
Travel: Willingness to travel occasionally as required
Company
Ventus Therapeutics
Ventus Therapeutics develops small molecule drugs that target autoimmune diseases, inflammatory diseases, and cancer.
11-50 employees
H1B Sponsorship
Ventus Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
Funding
Current Stage
Growth StageTotal Funding
$370.15MKey Investors
Michael J. Fox FoundationNovo NordiskRA Capital Management
2023-04-20Grant· $0.15M
2022-09-29Corporate Round· $70M
2022-02-09Series C· $140M
Leadership Team
Marcelo Bigal
President and CEO
Christine Ha
Chief Financial Officer
Recent News
BioWorld Financial Watch
2026-01-09
Pharmaceutical Technology
2025-12-24
Company data provided by crunchbase