Clinical Trial Manager

4D Molecular Therapeutics

11h

About The Position

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.

Requirements

B.A./B.S. degree
6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management
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 to effectively disseminate information to project team and outside parties
Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
Clinical research knowledge and cross-functional understanding of clinical trial methodology
Excellent organizational, conflict resolution, prioritization and negotiation skills
Proven ability in creative problem-solving and exercising sound judgment
Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
Ability to handle a high volume of highly complex tasks within a given timeline
Ability to develop Therapeutic Areas knowledge and expertise through internal training and external conference attendance
Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
Working knowledge of MS Project for development and update of clinical study timelines

Responsibilities

Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial
Lead cross-functional study execution team in support of study deliverables
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 that the 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
Participates in service provider selection process as a part of outsourcing activities
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
Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations
Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents
Manage clinical trial budgets, providing ongoing financial reporting and projections
Negotiate and finalize site contracts and budgets
Perform and manage 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, 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
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