Senior Director, Clinical Data Management

About us:

Ventus is a clinical-stage biopharmaceutical company with two novel small-molecule programs entering Phase 2 clinical trials for immunology, inflammation, and neurology therapeutic areas. The two wholly owned programs include VENT-03 a first-in-class, oral cGAS inhibitor expected to be evaluated for lupus and VENT-02 a brain-penetrant, oral NLRP3 inhibitor in development for Parkinson’s disease and osteoarthritis.

Our pipeline is powered by ReSOLVE® - a platform combining the latest advances in AI/ML (machine learning), protein science, structural biology, and biophysics to substantially increase the speed and accuracy of small-molecule drug discovery.

Job Description: 

 

The Senior Director, Data Management will be the first hire in the Clinical Data Management (CDM) function at Ventus, reporting to the Vice President, Head of Biometrics. In this role, you will be instrumental in establishing, refining, and leading the CDM function within a startup environment. You will oversee study-level data management activities initially and take a hands-on approach to build the necessary data management processes and infrastructure as our clinical trials evolve across multiple therapeutic areas in neurology, rheumatology, immunology & inflammation.  

As a working leader, you will play a key role in shaping and transitioning the clinical data management landscape, driving process improvements, overseeing data quality, and ensuring regulatory compliance.  

 

Position 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. 

 

Qualifications: 

• 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. #LI-Hybrid