Medical Director, Medical Affairs - Ophthalmology

Company: REGENXBIO
Location: Rockville
Posted on: September 12, 2020

Job Description:

Medical Director, Medical Affairs - Ophthalmology  About the Organization REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV® Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

Our gene therapy product candidates are designed to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins that are intended to impact disease. Through a single administration, our gene therapy product candidates are designed to provide long-lasting effects, potentially significantly altering the course of disease and delivering improved patient outcomes. We are currently developing gene therapy product candidates for the treatment of retinal, metabolic, and neurodegenerative diseases. Our product candidates all utilize AAV viral vectors from our proprietary gene delivery platform, which we call our NAV Technology Platform. In addition to our internal product candidate programs, we also selectively license our NAV Vectors to other leading biotechnology companies.

Req Number COR-19-00004

Description POSITION SUMMARY

The Medical Director, Medical Affairs (MA)- Ophthalmology is an in-house position that is based in Rockville, MD. Reporting to the Senior Director, Head of Medical Affairs, the incumbent will lead the development of Medical Affairs strategy in Ophthalmology, manage and support MA projects, coordinate the development of publications, presentations and MA deliverables, provide project management support, assist with MA research projects (such as natural history studies, registries, research collaborations), execute advisory boards, and manage KOL advisors. Position is focused in Retina Diseases with opportunities to cover other therapeutic areas.

Position Requirements PRIMARY RESPONSIBILITIES

Develop and implement MA strategy and plans including field medical plans, to support overall corporate objectives

Build relationships with thought leaders, clinical investigators, and other healthcare professionals /stakeholders, including patient groups and professional organizations.

Provide medical leadership, insight and strategy through collaborations with other internal functions and project teams (i.e. Commercial, Clinical, Operations, Regulatory, Biostatistics, Project Management, and Patient Advocacy).

Manage KOL advisors - develop strategy, draft scope of work, contracts, meetings, advisory boards, invoicing and payments.

Attend medical conferences as MA representative, assists with congress planning and strategy, lead meetings and assist with meeting summaries.

Assist with publication strategy across products - abstract planning, timeline management, presentation, poster, and manuscript development.

Identify and implement appropriate high-impact medical research projects to support the business objectives, including company-sponsored and investigator-initiated projects

Provide support for the development, review and approval of presentation materials for scientific meetings, conferences, and other publicly distributed materials.

Support Clinical Development on strategy, background research and problem solving

Participate in competitive intelligence and/or other market/industry assessment activities and projects and developing internal FAQs.

Maintain scientific and clinical knowledge in the specific disease area(s) and serve as key medical resources in the disease area and on specific products

Provide strategic input and training to the Medical Affairs organization.

SKILLS, KNOWLEDGE AND ABILITIES REQUIRED

Doctorate level degree required (MD, PharmD, PhD, or equivalent) with 3 or more years of relevant clinical or therapeutic experience (preferred),

Minimum 5 years Medical Affairs relevant experience within the pharmaceutical industry

Therapeutic area expertise in Ophthalmology required; Retina and/or Gene therapy experience preferred

TECHNICAL SKILLS

Superior medical writing, project management, communication, interpersonal and negotiating skills.

Ability to lead and manage high level projects.

Ability to proactively predict issues and solve problems.

Ability to drive decision-making within a multi-disciplinary team.

Diplomacy and positive influencing abilities.

Ability to independently manage multiple projects and vendors when necessary.

WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS

Ability to travel 25%.

MANAGER/SUPERVISORY RESPONSIBILITIES

None

Location Rockville, Maryland

Exempt/Non-Exempt Exempt

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.

Open Date 11/24/2019

This position is currently accepting applications.

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Keywords: REGENXBIO, Rockville , Medical Director, Medical Affairs - Ophthalmology, Other , Rockville, Maryland