[Hiring] Clinical Trial Manager @4D Molecular Therapeutics

Role Description

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.

Major Duties & Responsibilities

• Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants 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
  • 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 findings and ensure audit-ready condition of clinical trial documentation including central clinical files.
• Participate in service provider selection process as a part of outsourcing activities.
• Proactively identify, with the support and guidance from Senior Clinical Operations staff, and support development of plans and resolution of project issues and participate in process improvement initiatives as required.
• Support 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.
• Ensure tracking and review of protocol deviations and assess impact on study data.
• Develop and manage study budget and maintain within financial goals; Review and approve clinical invoices against approved budget.
• Provide 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.

Qualifications

• B.A./B.S. degree in Science.
• 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting a retina clinical trial.
• Global APAC experience desired.
• 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 includes Word, Excel, PowerPoint, and Outlook.
• Working knowledge of MS Project for development and update of clinical study timelines.

Requirements

• Travel: 5%.
• 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.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Benefits

• Hourly compensation range: $72.00 - $82.00 / HOUR.
• Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

Company Description

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.