- Location
- United States
- Type
- Internship
- Department
- Regulatory & Compliance
- Seniority
- Entry
- Education
- PhD
- Source
- Greenhouse
Description
Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.
Who is Harrow?
Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you’re the right person to help contribute as we build a truly exceptional company, one we are all so proud of!
Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:
- An expanding Retina Portfolio including IHEEZO®, TRIESENCE®, BYOOVIZTM, and OPUVIZTM
- A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and FRESHKOTE®
- A peri-operative Surgical product line, led by TRIESENCE®, and BYQLOVITM
- A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO®, NATACYN®, and VERKAZIA®
- A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01
Job 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
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 & Requirements
- 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.
Position Type
- Remote
Travel
- Up to 40%
