4D Molecular Therapeutics
- Senior Data Manager - Clinical Data
Senior Data Manager - Clinical Data
CA, United States
Job description
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.
4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.
We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.
To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.
In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.
Company Differentiators:
• Fully integrated clinical-phase company with internal manufacturing
• Demonstrated ability to move rapidly from idea to IND
• Five candidate products in the clinic and two declared pre-clinical programs
• Robust technology and IP foundation, including our TVE and manufacturing platforms
• Initial product safety and efficacy data substantiates the value of our platforms
• Opportunities to expand to other indications and modalities within genetic medicine
SUMMARY:
The Sr. Data Manager will be responsible for performing or overseeing vendors to perform Data Management operational end-to-end activities and participate as an active member in a cross-function study team to plan, lead, and execute tasks required for assigned clinical studies across all phases. The Senior Data Manager has a broad, fundamental knowledge of the data management process and can perform most required tasks with minimal guidance.
Data management is one of the essential functions of the Clinical Development organization at 4DMT. Together with the other two functions within the Data Science group, Biostatistics, and Statistical Programming, we provide critical support for the company’s clinical development programs in gene therapies for retina diseases and other therapeutic areas.
RESPONSIBILITIES:
- Lead Data Management of a clinical study or a series of related studies with minimal guidance
- Manage and monitor the progress of data management activities with CROs, vendors, and stats/programming groups on assigned studies
- Review protocols for appropriate data capture, including electronic Case Report Form (eCRF) design.
- Perform a thoroughly detailed review of eCRF data requirements.
- Lead the development of data edit check specifications and data listings
- Coordinate Electronic Data Capture (EDC) system design and testing according to company standards.
- Develop or lead the development of the Data Management and Data Transfer Plan for assigned clinical studies.
- Attend study meetings and provide Data Management updates and metrics.
- Review and provide feedback to the clinical team on other study documents, e.g., Clinical Monitoring plans, Statistical Analysis Plans, and vendor specifications
- Provide training on the EDC system and/or eCRF Completion Guidelines to internal and external study team members as needed
- Perform or ensure assigned CRO reconciliation of header data from external data sources against the clinical database
- Perform or ensure assigned CRO completed Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Lead database upgrades/migrations, including performing User Acceptance Testing
- Maintain data management files / eTMF
- Perform and coordinate database interim snapshot, lock, and freeze activities
- Other duties as assigned: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
QUALIFICATIONS:
Education:
- Bachelor’s degree or higher (life-science-related fields preferred)
Experience:
- 6+ years of data management experience in the biotech/pharmaceutical industry or clinical data management service providers. Of which at least three (3+) years in a lead study data manager role.
- Experience in retina diseases and/or gene therapies a plus.
- Hands-on operational experience as Data Management Lead in all phases of clinical trials, including development/deployment/validation/maintenance/closeout of a clinical database, coordination of data transfers/reconciliations, training on data management systems, etc.
- Experience in vendor management and performance assessments
- In-depth knowledge and expertise with CDISC data standards and models.
- Proficient in using clinical data management systems (e.g., Medidata Rave) and the data flow, including those from external sources (IRT, safety, central/specialty labs, reading centers, PROs, etc.)
- Proficiency in data management process and knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials
- Knowledge of ICH GCP and other applicable regulatory rules and guidelines.
- Knowledge of the clinical development process.
Skills:
- Proficient with MS Office (Word, Excel, PowerPoint, etc.)
- Excellent interpersonal communication skills (written and verbal)
- Innate collaborative attitude, with demonstrated ability to work effectively in a small company environment that moves at a tremendous pace.
- Excellent organization and project/time management skills
- Ability to multitask in a high-volume environment with shifting priority and conflicting deadlines
- Proven conceptual, analytical and strategic thinking
- Excellent attention to details
Base salary compensation range $164,000 - $196,000
Please note: the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience
