Clinical Trial Manager

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

GENERAL SUMMARY:

The Clinical Trial Manager will support the Company's clinical trial activities. This position reports to the Director of Clinical Operations. This will be responsible for management of the day to day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities. This position may support unmasked activities.

MAJOR DUTIES RESPONSIBILITIES:

Trial Management:

Serve as the primary unmasked contact for managing protocol execution, including oversight of the unmasked CRO, other study service providers, and consultants that are involved in a clinical trial

Serve as the primary sponsor-side unmasked contact for unmasked investigative site personnel

Support unmasked drug supply and accountability activities including oversight of IWRS system.

Act as the unmasked liaison between Clinical Operations and Clinical Supply

Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership

Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs

Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents

Ensure the unmasked Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews

Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files

Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required

Conduct unmasked study specific training of CRO study staff, monitors, investigational sites, and service providers

Perform and manage IP data review process on an ongoing basis

Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed

Oversee outsourced monitoring by reviewing unmasked monitoring reports to ensure quality and resolution of site-related issues

Ensures tracking and review of protocol deviations and assesses impact on study data

Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget

Provides oversight for forecasting of clinical supplies, including study drug and supplies

Department Management:

May manage and/or oversee work of junior Clinical Operations staff

May support development and review of Clinical SOPs and other department initiatives

Travel as needed to sites, conferences, industry meetings

Other duties as may be assigned

QUALIFICATIONS:

Education:

B.A./B.S. degree

Experience:

6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management

Other Qualifications/Skills:

(non-technical and technical skills)

Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills

Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners

Proven clinical operational skills to direct protocol execution to ensure timeline, budget and quality metrics are met

Excellent communication skills t…