Associate Director, Clinical Science

<p><strong>About the Role</strong></p> <p>Join us in advancing our pipeline to address a number of diseases across therapeutic categories including eye care, dermatology, and other diseases with high unmet needs.</p> <p>This role will be focused on the development of clinical strategies for assigned programs and is responsible for ensuring effective and efficient execution of the clinical development plan</p> <p><strong>Let’s talk about some of the key responsibilities of the role:</strong></p> <ul> <li>A leader with influence to present and collaborate with cross-functional team members to synthesize clinical data.</li> <li>Primary author for assigned clinical trial protocols, collaborating with and leading with other functions required for protocol development.</li> <li>Contributes or reviews clinical, regulatory, and relevant study documents, including Investigator Brochures, Clinical Study Reports, Statistical Analysis Plans, Operation Manuals, Investigational New Drug Applications/Clinical Trial Applications, case report forms, and data tables listings and figures.</li> <li>Educates internal and external team members on protocol execution.</li> <li>Primary point of contact to address or properly triage inquiries from site, CRO personnel, and site monitors, regarding study protocol, informed consent, and patient-specific questions.</li> <li>Reviews, finalizes, and updates information/data entered in clinical trial registries.</li> <li>Participates in development of Clinical Development Plan.</li> <li>Partners with data management on resolution of all clinical queries to sites.</li> <li>May participate in health authority interactions, as well as interactions with site Institutional Review Boards/ethics committees.</li> <li>Contributes to scientific abstracts for submissions to scientific conferences and publications for peer-reviewed journals.</li> <li>Creates, reviews, and/or presents clinical slides for internal meetings and external forums.</li> <li>Collaborates with biostatistics to develop data tables, listings, and figures.</li> <li>Identifies and tracks any potential safety events within a given study, or across studies for assigned programs.</li> <li>Conducts medical data review.</li> <li>Provides clinical development input to proposed revisions of SOPs and guidance documents.</li> </ul> <p><strong>Factors for Success:</strong></p> <ul> <li>Advanced clinical/science degree preferred (PharmD, PhD, OD, MD).</li> <li>10+ years minimum experience, with 3+ years of pharma/biotech experience or demonstrates relevant equivalent clinical research experience (Clinical Scientist) and 5+ years of experience with clinical trials. Eye care e