Director, Data Solutions and Optimization

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.

Datamanagement is one of the essential functions ofthe Clinical Development organizationat withthe other two functionswithintheData Science group Biostatisticsand Statistical Programmingwe provide critical supportforthe companys clinical developmentprograms in genetherapiesfor retina diseases and other therapeuticareas.

MAJOR DUTIES &RESPONSIBILITIES:

• Lead and manage Data Solutions & Optimization including clinical programming EDC programming data analytics and visualization functions.

• Develop and implement strategies foroptimizingdata flow database builds and integration of external technologies.

• Drivethe development of technical initiatives including EDC integrationparticipatein specification review &/or development ofSpotfire visualizations data currency and cleanliness metrics and visualizations and othersolutionsin partnership with IT System Owner & other key stakeholders.

• Ensurethe EDC platformis a qualified and validated systemand 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 supportofhigh-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 andmaintainthe 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 andobjectives.

• Function asa 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 managements right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

Education:

• B.A./ higher(life-science-relatedfields preferred)or equivalent experience.

Experience:

• 10 years of progressive experience in data management within biotech/pharma including at least 5 years in a leadership role.

• Provenhistoryof leading Data Programming for global clinical trials across all phases.

• Directoperational 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).

• Expertisein Data Governance Execution and Framework

• Extensive knowledge of CDISC standards including CDASH and SDTM.

• Experience in retina diseases and/or gene therapiesisa plus.

Other Qualifications/Skills:

• Strong leadership and team-building skills withabilityto influence across functions.

• Strategic thinker with operational excellence mindset

• Proficient in usingdata management systems (e.g. Medidata Rave Veeva) and data flow including those from external sources (IRT safety central/specialty labs reading centers PROs etc.)

• Proficiencyin 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 developmentprocessand risk-based trail management concepts.

• Proficient with MS Office (Worl Excel PowerPoint etc.)

• Exceptional communication and stakeholder management skills.

• Innate collaborative attitude withdemonstratedability 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 conceptualanalyticaland strategic thinking

• Excellent attention to details

Travel:5%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists hands and/or fingers. Fingering: Picking pinching typing or otherwise working primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideasby means ofthe spoken word.

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of forcefrequentlyor constantly lift carry push pull or otherwise move objects including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing arerequiredonly occasionally and all other sedentary criteria are met.

• Working Conditions - The worker is notsubstantially exposedto adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $214000 - 250000

Pleasenotethe base salary compensation range and actual salary offered to the final candidatedependsonvarious factors:candidatesgeographical location relevant work experience skills and years of experience.