- 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.
- 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
- 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
- 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.
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Director, Clinical R&D Applications - Emeryville, United States - BioSpace
Description
Job DetailsAttention 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
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:
Education:
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.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
