Skip to main content

This job has expired

You will need to login before you can apply for a job.

Senior Data Manager

Employer
4D Molecular Therapeutics
Location
Emeryville, California
Start date
Feb 14, 2024

Job Details

Attention recruitment agencies: All agency inquiries are vetted through Talent Acquisition. 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 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 Senior Data Manager will be responsible for performing Data Management activities that support observational clinical programs worldwide. They will participate as an active member of a cross-functional study team to plan, lead and execute the Data Management tasks required for all phase 1-4 studies. The Senior Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance. 

RESPONSIBILITIES: 

  • Lead Data Management of a clinical study or a series of related studies with minimal guidance 
  • Manage and monitor the progress of data management activities with CROs, vendors and stats/programing groups on assigned studies 
  • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design. 
  • Perform a thoroughly detailed review of eCRF data requirements.  
  • Lead the development of data edit check specifications and data listings 
  • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards.    
  • Develop or lead the development of the Data Management and Data Transfer Plan for a clinical study.  
  • Attend study meetings and provide Data Management updates and metrics. 
  • Review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical Analysis Plans and vendor specifications 
  • Provide training on the EDC system and/or eCRF Completion Guidelines to internal and external study team members as needed 
  • Perform or ensure assigned CRO reconciliation of header data from external data sources against the clinical database 
  • Perform or ensure assigned CRO completed Serious Adverse Event reconciliation activities according to SOPs and guidelines 
  • Lead database upgrades/migrations including performing User Acceptance Testing 
  • Maintain data management files / eTMF 
  • Perform and coordinate database lock and freeze activities    
  • Other duties 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: 

  • BA/BS degree or higher, preferably in medical or biological sciences 

Experience: 

  • Minimum of 6 years of CDM experience in the pharmaceutical industry. 
  • Minimum 3 years in lead data manager role. 
  • Minimum 3 years experience with Medidata Rave / iMedidata 

Skills: 

  • Excellent written and verbal communication skills and collaborative working style. 
  • Proven conceptual, analytical and strategic thinking. 
  • Experience standardizing CDM & data flow processes. 
  • Demonstrated project management skills. 
  • Proactively identifies risks, issues, and possible solutions. 
  • Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities and/or conflicting deadlines. 
  • Ability to build a rapport and trust with others through leadership and dependability. 
  • Extensive knowledge of Clinical Systems (e.g. EDC, IXRS) and external data vendors (e.g. Central Laboratories). 
  • Knowledge of GCP/FDA/ICH regulations required. 

Base salary compensation range:

National:  $159,000 - 195,000

Bay Area:  $174,000 - 219,000

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

Company

4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.


At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.


While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.


At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.


4D Purpose Statement:  Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients


GUIDING PRINCIPLES

 

  • Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
  • Break Boundaries - Question the status quo and innovate beyond conventional approaches
  • Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
  • Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans


We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers generous benefits and provides challenging opportunities for career development. 
 

Company info
Website
Phone
510-505-2680
Location
5858 Horton St. Suite 455
Emeryville
California
94608
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert