Sr. Clinical Trial Associate

4 weeks ago

Emeryville, 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:  

4DMT seeks a motivated and experienced Senior Clinical Trial Associate to support the Company's clinical trial activities.  This position reports to the CTM/Sr. CTM, Clinical Operations and will be responsible for supporting the day-to-day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close-out activities.  This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines.  This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.

 

RESPONSIBILITIES:   

Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF) Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes) Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders) Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance Assist with the development of site tools and clinical trial start-up activities Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations Assist in tracking of trial IP and development of Pharmacy Manuals Participate in study vendor set up and specification process, as appropriate Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities Assist with tracking of clinical trial progress including status update reports, as requested Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues Other duties as may be assigned

QUALIFICATIONS:  

BA/BS, degree required At least 2 years of work experience supporting clinical trials Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook Ability to prioritize and manage competing priorities Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners Willing to travel as business needs demand (

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