Senior Director, Clinical Science

Job not on LinkedIn

November 14

Apply Now

Receive Emails with Similar Jobs

4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations.

51 - 200 employees

📋 Description

• Partner with cross-functional program team members and key R&D stakeholders to support the development of innovative study designs, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials • Provide clinical support for clinical study conduct, including operational feasibility, data management, communication plans, safety and medical monitoring, preparation of meeting materials and study updates. • Provide scientific support and cleaning/querying of key safety and efficacy data for ongoing clinical trials throughout conduct • Prepare and communicate clear overviews of trial results. • Identify issues related to study conduct and/or subject safety. Provide preliminary assessments and recommendations and collaborate with the clinical team to develop solutions ensure resolution. • Interact with internal and external stakeholders (study sites, vendors, KOLs, etc.) in support of program-level strategy as well as clinical trial objectives • Act as recognized clinical expert for assigned programs. • Contribute to the preparation of medical and scientific data for publications, presentations, and study milestones (including meetings for Executive Team, Board of Directors, Advisory Boards and Data and Safety Monitoring Committees [DSMC]) • Together with Medical Director of Ophthalmology, serve as a point of contact for the clinical operations personnel, clinical trial sites and CROs for clinical science questions • Maintains knowledge of ICH-GCP and FDA IND, and external regulations and procedures. • Contribute to authoring clinical documents such as protocol synopsis, clinical study reports, IBs, ICFs, training documents, and other clinical documents. • Author pertinent clinical sections of regulatory filings, including preparation of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other regulatory submissions • Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

🎯 Requirements

• A./M.S. in a biological/health science field is required • OD, PhD, or PharmD preferred • A./M.S. with 12+ years Clinical science experience, or OD, PhD or PharmD with 8+ years of experience with 5+ years of drug development with experience in ophthalmology drug development, preferably in retinal disease • Advanced experience in clinical trial design, implementation, regulatory document preparation and statistics. • Phase 3 experience, retinal gene therapy experience, NDA/BLA/MAA submission experience • Ability to interpret, analyze, and present clinical data • Thorough understanding of the drug development process • Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization). • Demonstrated ability to communicate and write clearly, concisely, and effectively. • Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy. • Understanding of trial design and statistics • Well-organized: ability to prioritize tasks with a successful track record of managing multiple projects in a fast-paced and deadline-driven environment. • Good leadership and management skills to manage internal and external collaborations and work well within cross-disciplinary teams.

🏖️ Benefits

• Equal employment opportunities