Clinical Trial Manager (Contract)

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 deliveryGENERAL 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 is a 6 month contract remote opportunity.   MAJOR DUTIES & RESPONSIBILITIES:  Trial Management:   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  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 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   Travel: 5%  Physical Requirements and Working Conditions:  Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.

Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.  Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.

Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.  Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).  HR ONLY: Hourly Compensation Range: $84.00 - 94.00 Please note, the compensation range and actual rate offered to the final candidate depends on various factors: candidate’s geographical location, 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

4D Molecular Therapeutics is a leading biotechnology company specializing in gene therapy, founded in 2013. The company is at the forefront of developing innovative therapies using cutting-edge technology to address genetic diseases. 4D Molecular Therapeutics is revolutionizing the field of medicine with its groundbreaking approach to gene therapy, offering promising solutions for patients with previously untreatable conditions.