Associate Director, Clinical Affairs

Role Summary

The Associate Director of Clinical Affairs is a key contributor to the creation and execution of the Clinical Affairs strategy and tactics. This position will be involved in all aspects of Clinical Affairs such as designing and supporting clinical studies, protocol development, clinical site evaluations, as well as clinical study execution.

Responsibilities

• Execute Clinical Affairs strategies, including engagement with opinion leaders, principal investigators, and intracompany collaborators.
• Support Clinical Operations and Clinical Development to facilitate enrollment of company-sponsored clinical trials.
• Oversee clinical research organizations (CROs) as they engage in Harrow-sponsored clinical studies from start-up through close-out. Provide timely responses to regulatory-oriented queries in relation to Harrow-sponsored clinical studies planned, in progress, or executed.
• Work collaboratively with cross-functional colleagues (e.g., marketing, sales, patient advocacy, medical affairs, regulatory, legal, and market access) to develop and execute clinical plans.
• Foster an environment of compliance and integrity by managing and adhering to all company policies, internal SOPs, and Legal and Regulatory guidelines.

Qualifications

• Required: Terminal Degree MD/DO/OD/PhD/PharmD.
• Required: A minimum of 4 years of pharmaceutical industry experience, preferably in Ophthalmology, in a Clinical Affairs or Clinical Operations capacity.
• Required: Successful record in designing and executing clinical trials.
• Preferred: Ophthalmic experience.
• Preferred: Experience in scientific presentations and medical writing.
• Preferred: Experience utilizing statistical analysis software.
• Preferred: Broad knowledge of product development, regulatory requirements, payer landscape, and life cycle management.
• Preferred: Proven ability to develop and foster peer-to-peer, credible relationships with Medical Experts/decision makers.
• Preferred: Strong analytical skills and ability to interpret scientific/clinical literature.
• Preferred: Proficient with MS Office applications.
• Required: Fluency in reading, writing, understanding, and communicating in English.

Additional Requirements

• Position Type: Remote.
• Travel: Up to 40%.
• Must live within a 45-minute commute to a major airport.