Job Description

What you'll do:

• Support the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.)
• Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites.
• Support cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures.
• Engages clinical trial vendors to support study start-up activities in line with the clinical trial design
• Provides medical monitoring support or oversight of activities conducted by a CRO, which includes monitoring, cleaning, analyzing, and reviewing efficacy data to establish the presence or absence of trends and follow up as appropriate
• Collaborate on, or lead where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses.
• Support clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning
• Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.

About you:

• MD, PhD, OD, PharmD with ophthalmology experience, preferably including retina experience required. Gene Therapy experience also preferred.
• 5-7 years of experience in a clinical research-related role. 3-5 years' experience in a Clinical science/development role preferred.
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, understanding of functional and cross-functional relationships
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
• Knowledge of gene and ocular therapies preferred
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Previous experience working with CROs and other vendors/suppliers preferred
• Previous experience with Phase I-III US and Global/Ex-US clinical trials preferred
• Excellent verbal, written, communication and interpersonal skills
• Proficient in Medical Terminology and medical writing skills
• Proficient critical thinking, problem-solving, decision-making skills
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
• Proficient in Microsoft Word, Excel, PowerPoint, and general computer use. Experience using Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools would be a plus.