Senior Director, Data Management

2 months ago

Emeryville, California, United States 4D Molecular Therapeutics Full time

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

GENERAL SUMMARY:

The Sr. Director of Data Management will be an experienced, hands-on data manager who heads the Data Management function of the Data Science group within the Clinical Development organization. Data Management and the other two functions in the Data Science group, Biostatistics and Statistical Programming, provide critical support for the company's clinical development programs in gene therapies for retina diseases and other therapeutic areas.

This Sr. Director of Data Management will provide strategic/technical inputs and oversight to Data Management operational activities, be accountable for high-quality data management deliverables, and manage and build the Data Management team.

RESPONSIBILITIES:

Data Management Leadership: 70% of TIME

Provide overall leadership and functional mentorship of the Data Management team, managing and optimizing resources to achieve functional goals and business objectives.
Effectively promote innovation in data sciences in cooperation with peers across all company functions.
To improve efficiency, provide strategic and technical leadership across multiple drug development phases, including standardization, automation, process improvement, and technical enhancement in clinical data management (CDM).
Ensure high quality and effective conduct of Data Management functions.
Guided in developing and implementing data management standards, processes, and infrastructure to ensure adherence to regulatory compliance, ICH GCP guidelines, and good clinical data management practices.
Co-lead the design of standardization of the data repository in the Data Sciences group.
Collaborate with relevant functional areas to reach key R&D milestones.

Clinical Trial Support: 30% of TIME
Utilize and assign resources toward cross-functional design and operationalization of clinical trials from a data management standpoint.
Utilize/build resources to work with cross-functional teams to ensure high-quality and prompt data management deliverables for milestone data reviews/analyses/releases.
Accountable to ensure regulatory requirements related to the specific therapeutic areas and implications are integrated into data collection in clinical trials.
Ensure strategic and compliant integration of CROs regarding data management activities
Keep management abreast of issues and progress on projects.
Other responsibilities 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:
15+ years of data management-related experience in the biotech/pharmaceutical industry or clinical data management service providers.
Work with Retina diseases and/or gene therapy
6+ years of people management experience (Data Management staff preferred)
Deep hands-on operational experience as Data Management Lead in all phases of clinical trials, including development/deployment/validation/maintenance/closeout of the clinical database, coordination of data transfers/reconciliations, training on data management systems, etc.
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.)
Demonstrated proficiency in the data management process and expert knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials
Demonstrated in-depth understanding of ICH GCP and other applicable regulatory rules and guidelines.
Experience in identifying/authoring SOPs and Work Instructions in clinical data management processes
Knowledge of the clinical development process.

Skills:
Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the organization.
Proficient with MS Office (Word, Excel, PowerPoint, etc.).
Innate collaborative attitude, with demonstrated ability to work effectively in a small company environment that moves at a tremendous pace.
Ability to multi-task in a high-volume environment with shifting priorities and/or conflicting deadlines.
Excellent interpersonal communication skills (written and verbal)
Excellent organizational and project/time management skills

Base salary compensation range $235,000/yr - $300,000/yr
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
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

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