Job Title: Senior Director, Medical Lead, Ophthalmology
Job Number: 21482
Location: Cambridge, MA
The Medical Lead, Ophthalmology Development will be responsible for leading Casebia’s ophthalmology projects in translational and clinical development and will play an important role in advancing the company’s overall R&D strategy. S/He will be leading the relevant ophthalmology cross-functional project teams from stage of IND/CTA-enabling studies through late stage development and post-commercialization studies. As such, S/He will be primarily responsible for providing medical and clinical leadership for the project teams, including supporting clinical safety. Reporting into the Chief Medical Officer, the successful candidate will be working closely with all discovery, CMC, clinical development, project management, and regulatory functions to enable successful advancement of ophthalmology assets into the clinic and through licensure.
The successful candidate will be a confident and respected leader with significant prior industry success in a relevant therapeutic area, most preferably ophthalmology. This person will also ideally have a solid scientific understanding of the biology and development of advanced therapeutic modalities for the eye such as gene therapy. The ideal candidate will likely have prior experience bringing novel and complex programs from preclinical research through development, into the clinic and gaining approval by US and global regulatory agencies. This requires novel strategies and deep knowledge of all aspects of regulations and practices in both the US and EU. We are seeking someone with a sense of urgency for developing new therapies for devastating diseases and who is interested in forging new and uncharted paths for patients using the exciting CRISPR/Cas 9 technology. S/he is expected to model and inspire a strong collaborative and can-do attitude across the different functions of the company, including serving as an individual team member.
- Serve as primary medical leader in the ophthalmology matrixed Project Teams (with Project Management, Clinical Operations, Discovery, Translational Medicine, Regulatory Affairs, Database Management & Programming, Biostatistics, and Commercial)
- Design, development and implementation of Clinical Development Plans for various ophthalmology programs
- Be the primary responsible clinical officer for assigned programs
- Proactively identify program risks, and create and implement mitigation strategies
- Serve as primary liaison with key opinion leaders, and potential clinical site
- Handle day-to-day clinical, medical, scientific questions from various internal and external sources
- Collaborate cross-functionally in the preparation of the IND, CDP, clinical protocols, investigator brochures and target product profiles
- Participate in the ongoing interpretation and analysis of pre-clinical and clinical trial results including pharmacokinetics, pharmacodynamics, laboratory, imaging, and antibody data, review and approve clinical trial coding; safety monitoring in collaboration with pharmacovigilance expert
- Participate as medical lead in various scientific advice meetings with the EMA and FDA, or other Regulatory bodies
- Continual review and analysis of the pertinent medical (disease-specific) literature
- Preparation and/or delivery of abstracts, posters, and slide presentation at external Conference Symposia, and manuscripts for peer-reviewed journals
- Collaborate on, and lead as appropriate, the commercial assessment of assigned assets and development programs
- With Business Development function, participate as medical expert in Company due-diligence exercises on potential in-licensing of pipeline gene therapy programs
The successful candidate we hire will be an accomplished leader who is passionate, driven, and biased for action. S/he will have the following mix of personal and professional characteristics:
- MD degree, clinical specialty training, and board certification (or equivalent) in ophthalmology
- 7+ year-experience in ophthalmology clinical development, in US or EU. Title and compensation will be commensurate with experience
- Strong scientific, medical and regulatory expertise as related to ophthalmology development (preferably in rare diseases or genetic therapies)
- Experience leading or collaborating on IND preparations, clinical development plans, and BLA approvals in US and/or global equivalents
- Excellent working knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
- Proven ability to prioritize, meet deadlines, and manage competing priorities and changing demands
- Sound organization and time management skills
- Good attention to detail and accuracy whilst maintaining high quality GCP standards.
- Ability to follow instructions/guidelines, work independently and proactively on own initiative.
- Ability to be flexible and receptive to changing process demands
- Willingness and aptitude to learn new skills, and support activities across service lines.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients – many with diverse cultural backgrounds
- Skill required to create buy-in from functional groups and departments
- Outstanding communication skills; comfortable representing the company and vision to internal and investor communities.
- Confident, independent and decisive; a self-starter, proactive and results-oriented with high performance standards. Passionate, persistent and tenacious. Strong ability to prioritize and operate with a sense of urgency.
- “Hands-on”, “roll-up-the-sleeves” leader who understands the need for involvement at all levels of activity within a small company environment. Extremely bright with a highly strategic nature but also balanced with a biotech mindset and an attitude that gets things done.
- Understanding of and willingness to meet applicable regulatory, quality and compliance standards. Trustworthy with highest integrity, committed to ethics and scientific standards.
- Willingness to travel (domestic/international, approximately 20% time) to meet investigators, attend conferences, and participate in advisory boards.