Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The Opportunity
The Senior Medical Director - Ophthalmology will be responsible for providing innovative scientific knowledge, skill, and technical expertise for assigned clinical programs, and projects at REGENXBIO. This position is responsible for the development of gene therapy products to treat neovascular (wet) age-related macular degeneration. REGENXBIO utilizes a cross-functional product development team approach to effectively support the initiation, development and registration of candidate drugs. The Clinical Development Lead will play a key role in leading a pivotal study as one of 2 studies in the pivotal program.
The position will be responsible and accountable for leading clinical strategy and execution of the pivotal program as well as assist with strategy and execution across the ABBV-RGX-314 program.
What You'll Be Doing
- Accountable for clinical strategy, including the clinical development plan, and execution of clinical strategy by the clinical sub teams.
- Accountable for leading the executing the pivotal SR wAMD program.
- Works in collaboration with external and internal experts to generate innovative development plans that create the best balance of time, resource and risk while ensuring the proposed plans align with the overall corporate strategy.
- Represents clinical on the cross-functional program core team.
- Accountable for clinical input and clinical sections of the Product Development Plan.
- Lead clinical representative with external study sites to train, guide and answer questions and responsible for oversight of study site’s conduct in the trial.
- Accountable for safety and medical monitoring and clinical trial oversight along with safety team.
- Leads safety review for IDMC for the study.
- Leads and/or participates in clinical/medical advisory panels and investigator meetings.
- Contributes as author and provides clinical review of protocols, clinical study reports and publications.
- Provides support to publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals.
- Remains up-to-date with current information on regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
- Provides credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
- Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
- Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders
- Accountable for the adherence to Good Clinical Practice, data integrity principles and other key REGENXBIO policy requirements by external and contract partners
- May be required to travel up to 10-25% of the time (which includes Retina meetings, internal meetings, site visits when appropriate).
- It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
- The ideal candidate will have the required blend of scientific knowledge, drug development expertise, business acumen and leadership ability. Previous experience leading a clinical trial and leading all clinical activities associated with trial execution. Background and experience in Ophthalmology clinical research required.
- Doctorate level degree required - M.D. preferred
- Proven track record of experience and leadership in drug development
- Practical experience including, development of clinical investigational protocols, implementation of protocols, interpretation of data, and interactions with regulatory bodies
- Excellent leadership skills
- Deep knowledge of drug development from end to end
- Ability to manage multiple and diverse internal/external collaborations at different stages of development
- The ability to work well under intense pressure, tight timelines, and in rapidly changing situations
- Evidence of an entrepreneurial spirit and a capacity to find creative solutions to unexpected hurdles
- Interacts effectively across boundaries with supporting REGENXBIO functions and disciplines using influencing, communication and relationship building skills
- Commitment to anticipate, influence and direct change
- Excellent listening and collaboration skills
- Experience in Ophthalmology required and gene therapy and/or surgical experience preferred
Why Should You Apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally. Apply for this job
