The Senior Medical Director will serve as the clinical lead for ophthalmology programs, with a focus on Ophthalmology indications. This role will oversee the design, execution, and analysis of clinical trials and play a key role in shaping development strategy.
Key ResponsibilitiesLead cross-functional study execution teams across clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance management
Serve as medical monitor for clinical studies, ensuring patient safety and data integrity
Author and review clinical development plans, study protocols, amendments, informed consent forms, investigator brochures, INDs, annual reports, clinical study reports, and regulatory submissions
Organize and lead scientific advisory board meetings, engaging with external experts to inform program strategy
Identify and assess new clinical opportunities in collaboration with research and portfolio teams
Anticipate program risks and develop mitigation strategies
Represent the company at external meetings, conferences, and with regulatory authorities
Education
MD with residency training in Ophthalmology
Experience
8+ years of clinical ophthalmology research in the biopharmaceutical industry
Proven experience leading Phase I=III clinical trials
Gene therapy experience strongly preferred
Experience contributing to NDA/BLA/MAA submissions
Skilled in writing clinical research protocols, serving as a medical monitor, and interpreting clinical data
Skills
In-depth knowledge of ICH-GCP and FDA regulatory guidelines; international regulatory familiarity is a plus
Strong communication skills, both written and verbal, including public speaking
...Materials Engineer job opening with a global leader in packaging development and sustainable business practices. This position resides at the plant level. The individual will have the responsibility to develop the next generation product materials. Next generation materials...
Office Manager for homeless shelter and permanent supportive housing Location Buffalo, NY : Our company is looking to hire an office manager to be responsible for the general operation of our office. Duties will involve greeting visitors, answering incoming phone calls...
...Physical Therapy Assistant Rutland-VT-05701-United States Under the direction and supervision of the Manager and/... ...Knowledge, and Abilities Written and verbal communication with physicians, allied health professionals and patient/family. Patient...
The in-school ACT instructor (ISACT) is an uncommonly hardworking, resourceful educator whos passionate about expanding college access for BRYCs Junior Fellows (11th-graders) through improved ACT scores.Unlike BRYCs flagship after-school programs at our Downtown and...
...rep with their own book of business that is looking for improved service for their clients What Were Offering: Work from home and set your schedule Well manage your jobs from start to finish, so you can focus on sales We'll schedule your orders, send...