- Develop translational medicine and clinical development strategies for multiple clinical programs in severe genetic diseases, with an initial focus on inherited retinal diseases.
- Lead activities related to first in human through registrational clinical trials on a global basis (e.g., develop protocols, investigator brochures, review clinical trial documents, clinical support of regulatory interactions, and study pharmacovigilance, data analysis and reporting).
- Establish and lead clinical development capabilities at SalioGen though targeted hiring and retention clinical operations staff, consultants and other outsourced service providers to execute initial clinical trials through a CRO-supported outsourced model.
- As member of Program teams, collaborate with Portfolio & Program Management, Regulatory, Research and Manufacturing stakeholders to ensure timely and effective clinical and scientific input into all development programs.
- Lead advisory boards with key opinion leaders and investigator meetings with clinical trial investigators, and partner with Clinical Operations in driving enrollment into the clinical studies.
- Provide clinical input into statistical planning and lead data analysis and interpretation.
- Provide medical leadership as needed for clinical and scientific issues that may arise during clinical trial execution, including adverse events and pharmacovigilance.
- Create medical monitoring plans and oversee medical monitoring for one or more clinical studies.
- Provide medical leadership and support for publication of data (e.g., manuscripts, posters) and disease or technology-related scientific publications.
- Represent the company at medical and scientific meetings, patient advocacy events and presentations, as well as other external-facing activities (investors, business development, media).
- 10+ years relevant biotechnology/pharmaceutical experience leading clinical drug development (first-in-human through approval), including developing clinical protocols, study design and successful regulatory approvals (INDs, CTAs, BLAs, NDAs) with US and international regulatory agencies.
- Strong scientific and medical background and ability to educate physicians and regulators on cutting-edge genetic medicine approaches.
- Proven clinical development experience designing, implementing and conducting gene therapy clinical trials in ophthalmology
- A history of strong collaboration and personal interaction with all levels of internal stakeholders including: Regulatory, Clinical Operations, Manufacturing, Research and Program Management.
- Outstanding leadership skills: comfortable navigating a dynamic, changing environment through creativity and collaboration.
- Experience working in smaller entrepreneurial biotechnology companies, with additional experience in larger biotechnology or pharmaceutical companies also valued.
- Demonstrated ability to manage multiple priorities to achieve results and meet milestones in a "hands-on" fashion.
- Willingness to travel ~25%, with occasional international travel at times.
- MD, with specialty training in Ophthalmology preferred
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Vice President, Clinical Development - Lexington, United States - SalioGen Therapeutics
1 week ago
Description
About Us:
At SalioGen, we are leveraging the intrinsic genome engineering features of human evolution to harness the power of genetic medicine.
Our approach, which we call "Gene Coding", is guided by our Exact DNA Integration Technology (EDIT): a genome engineering platform using the proprietary mammal-derived enzyme saliogase.
With broad applicability, non-viral delivery capabilities of any size gene, redosability, and significant manufacturing advantages, our platform technology has the potential to transform genetic medicine.
Join our team of leading scientists, expert drug developers, and biotech industry veterans. Together we are working to transform the treatment landscape of genetic diseases.Position Summary:
The Vice President, Clinical Development will provide hands-on medical leadership to advance SalioGen's novel, in vivo genetic medicines into the clinic, with an initial focus on inherited retinal diseases, including a lead program for Stargardt disease entering the clinic in the first half of 2025.
This clinical leader is responsible for the development and execution of translational medicine and clinical development strategies including the design, execution, monitoring, data analysis, and reporting of clinical studies for one or more programs.
In addition, they will collaborate with other team members and functions to develop and execute upon long-range strategic plans for SalioGen's programs.
Member of the Executive Team and potential for elevation to Chief Medical Officer based on performance.Primary Responsibilities:
Qualifications & Skills Required:
Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
