Director, Data Solutions and Optimization

4D Molecular Therapeutics

6h•$214,000 - $250,000

About The Position

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY: The Director, Data Solutions & Optimization leads the development and execution of data solutions initiatives, overseeing EDC solutions vendors, managing clinical and EDC programming, database management, and data analytics. This role will manage and optimize key processes within data management and lead technological strategies, collaborating with internal teams and external vendors to drive innovation and operational efficiency. This role will play a pivotal role in aligning technological advancements with business goals, ensuring high-quality, timely delivery of critical clinical trial data. 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.

Requirements

B.A./B.S. degree or higher (life-science-related fields preferred), or equivalent experience.
10+ years of progressive experience in data management within biotech/pharma, including at least 5 years in a leadership role.
Proven history of leading Data Programming for global clinical trials across all phases.
Direct operational experience as Data Programming 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.
Knowledge of FDA and EMA regulations, including 21 CFR Part 11, Parts 210/211, EU Annex 11, CSA principles, and GDPR.
Experience in oversight of CRO programming resources and performance assessments (FSP oversight experience is a plus).
Expertise in Data Governance Execution and Framework
Extensive knowledge of CDISC standards, including CDASH and SDTM.
Strong leadership and team-building skills with ability to influence across functions.
Strategic thinker with operational excellence mindset
Proficient in using data management systems (e.g., Medidata Rave, Veeva) and 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.
Understand drug development process and risk-based trail management concepts.
Proficient with MS Office (Worl, Excel, PowerPoint, etc.)
Exceptional communication and stakeholder management skills.
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

Nice To Haves

Experience in retina diseases and/or gene therapies is a plus.
Experience in oversight of CRO programming resources and performance assessments (FSP oversight experience is a plus).

Responsibilities

Lead and manage Data Solutions & Optimization, including clinical programming, EDC programming, data analytics, and visualization functions.
Develop and implement strategies for optimizing data flow, database builds, and integration of external technologies.
Drive the development of technical initiatives, including EDC integration, participate in specification review &/or development of Spotfire visualizations, data currency and cleanliness metrics and visualizations, and other solutions in partnership with IT System Owner & other key stakeholders.
Ensure the EDC platform is a qualified and validated system and manage the impact analysis of system updates, ensuring ongoing system optimization, risk mitigation, and cross-functional awareness.
Lead data standards initiatives including data cleaning and reporting tools and standard CRFs and edit checks, ensuring alignment with current CDISC SDTM standards.
Drive process improvements, workflow optimizations, and the development of new SOPs to enhance operational efficiency.
Provide strategic oversight and support of high-priority projects, including database builds, freezes, and locks, user access management for data systems, and evaluation of system updates.
Mentor and develop team members, fostering a culture of continuous learning and growth within the team.
Ensure compliance with all relevant data privacy regulations and maintain the security of clinical trial data.
Collaborate with other departments (i.e., IT, Clinical Operations, Clinical Science, etc.) to align data strategies with broader organizational goals and objectives.
Function as a key stakeholder in developing and executing strategies to accelerate drug development through innovative data management practices.
Other duties assigned: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time