Sr. Director, Clinical Science

GENERAL SUMMARY:

The Senior Clinical Scientist 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.

MAJOR DUTIES & 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 managements right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

Education:

• A./M.S. in a biological/health science field is required
• OD PhD or PharmD preferred

Experience:

• 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

Other Qualifications/ Skills:

• 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%

Physical Requirements and Working Conditions:

• 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. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $268000/yr - $341000/yr