Director, Clinical R&D Applications

2 weeks ago


Emeryville, United States 4D Molecular Therapeutics Inc. Full time

GENERAL SUMMARY:

This role is responsible for leading & managing the technology & data strategy & execution for the Clinical R&D functions. This includes developing & implementing technical & compliant solutions that support the clinical research & development processes, from study design & execution to data analysis, reporting & submission. The role partners closely with Clinical R&D leadership to ensure successful functional strategic execution including pivotal phase 3 clinical trials.

RESPONSIBILITIES:

* In close partnership with Clinical R&D business process owners, sponsors & stakeholders including Clinical Science & Operations, Data Management & Biostatistics, Regulatory Affairs, PV, Biometrics, & Clinical Quality, provide leadership & subject matter expertise to drive timely & compliant planning, evaluation, procurement, implementation & operation of Clinical R&D systems.
* Define the Clinical R&D systems & data architectural landscape & strategic roadmap to align with corporate objectives including Phase 3 & inspection readiness.
* Liaise & guide business owners & stakeholders, solution providers, IT & QA to define system implementation strategies/roadmaps, scope, schedule, budgets & roles/responsibilities in order to proactively ensure compliance & success of pivotal trials, inspections, internal audits & periodic reviews.
* Apply 4DMT's Computer System Validation/SDLC procedures to Clinical R&D GxP Systems:
* Drive the development &/or refinement of system requirements by working cross-functionally to identify future state process & data requirements.
* Lead the assessment process for new computerized systems.
* Author validation deliverables & / or provide guidance to resources responsible for authoring validation deliverables as projects are planned & executed.
* Review validation documentation generated by external resources.
* Author change request deliverables to support system changes.


* Serve as the 4DMT IT system owner for Clinical R&D applications, responsible for:
* Authoring / maintaining 4DMT system management documentation.
* Working with software / hosting vendors, &/or business to support resolution of time-sensitive business, technical or compliance issues.
* System configuration / change management
* User/Access Management & training
* Data governance & management strategy


* Strategize cross-functionally to develop new procedures & practices to ensure Clinical R&D systems and data are managed efficiently & in compliance with 4DMT procedures & applicable regulations such as 21 CFR Part 11 & Annex 11.
* Work with the business, IT & vendors as applicable to ensure adequate system processes/controls are in place to support data integrity, such as data backup / recovery, role-based security, user provisioning / training & compliant audit trail capabilities.
* Conduct work activities in compliance with 4DMT SDLC, Change, Access, Inventory, Employee Change Mgmt & other key operational management procedures & Policies.
* Lead the strategic planning, development, & implementation of a unified R&D global data strategy, encompassing AI & ML initiatives, data governance, & data management to achieve 4DMT mission & objectives.
* Serve as a key thought leader in data strategy, driving thought leadership & inspiring innovation within 4DMT & the broader healthcare/life sciences community.
* Keep abreast of the latest industry trends, advancements, & best practices in data management, AI, ML, & healthcare/life sciences.
* Maintain operational excellence principles & lead continuous improvement initiatives to maximize business value from technologies & data.

QUALIFICATIONS:

Education:

* BS/BA required with a technical major, such as engineering or computer science preferred
* MS/MA preferred
* Veeva Vault Platform Administrator certification or similar experience a plus

Experience:

* 10+ years working in a GxP regulated environment, supporting Clinical R&D systems & data through at least one Phase 3 clinical trial, one inspection & multiple regulatory submissions.
* 10+ years working with CSV, SDLC, Change & Access Mgmt.; CFR Part 11 / Annex 11 compliance; data integrity methodologies; & regulatory standards such as IDMP.
* 15+ years working in IT or in a Clinical IT role.
* 3+ years working at a gene therapy or similar biotech strongly preferred

Skills:

* Deep understanding of Clinical R&D business processes.
* Excellent technical skills & proven, hands-on administration experience with Clinical R&D cloud & on-prem technologies including Medidata Rave, SAS, Veeva, RIM, QMS, LIM, eCTD Publishing tools, centralized data governance systems & repositories, analytics & AI/ML tools.
* Strong knowledge of IT operations, security best practices, project management methodologies, continuous improvement & organizational change management.
* Outstanding presentation skills & professional presence.
* Contributes to a positive culture & thrives within a high-growth, fast-paced small company.
* Accountable, self-driven & excels working in an independent/autonomous environment with minimal oversight.

Base salary compensation range:

Bay Area Range: $227,000/yr - $256,000/yr

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.



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