Senior Director, Clinical Science

4D Molecular Therapeutics•Emeryville, CA

20h•$268,000 - $341,000

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: Reporting to the VP Clinical Science, the Senior Director, Clinical Science will play an integral role in facilitating successful advancement of ophthalmology gene therapy programs. The position supports clinical and scientific aspects of all assigned clinical programs.

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 exeirence 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.

Nice To Haves

OD, PhD, or PharmD preferred

Responsibilities

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