Senior Director, Clinical Science

Summary

Join 4DMT, a clinical-stage biotherapeutics company, as a Senior Clinical Scientist to play an integral role in advancing ophthalmology gene therapy programs. You will support clinical and scientific aspects of assigned programs, partnering with cross-functional teams. Responsibilities include developing study designs, clinical trial protocols, and other documents; providing clinical support for study conduct; preparing and communicating trial results; identifying and resolving issues; interacting with stakeholders; and acting as a clinical expert. You will contribute to publications, presentations, and regulatory filings. The position requires a strong background in clinical science, ophthalmology drug development, and regulatory affairs. A competitive salary and benefits package is offered.

Requirements

• A./M.S. in a biological/health science field is required
• 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
• Travel: 10%

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

Preferred Qualifications

OD, PhD, or PharmD preferred

Benefits

Base salary compensation range: $268,000/yr - $341,000/yr