[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.
Qualifications
• 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 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.
• 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
• Base salary compensation range: $150,000 - 172,000
• 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.
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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.
Qualifications
• 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 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.
• 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
• Base salary compensation range: $150,000 - 172,000
• 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.
Apply tot his job
Apply To this Job