[Hiring] Associate Director of Clinical Affairs @Harrow, Inc.

Role Description

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
• Clinical study execution

Core 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 on 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

• 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 required.
• 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 and experience to develop and foster peer-to-peer, credible relationships with Medical Experts/decision makers.
• Strong analytical skills, ability to interpret scientific/clinical literature.
• Proficient with MS Office applications.
• Fluency in reading, writing, understanding, and communicating in English is required.
• Travel Requirements: 40%
• Must live within a 45-minute commute to a major airport.

Requirements

• Position Type: Remote
• Travel: Up to 40%