Ocular Therapeutix, Inc VP, Clinical Development - Ophthalmology in Bedford, Massachusetts
A unique opportunity to become an integral part of a rapidly emerging and innovative ophthalmic biopharmaceutical company. Ocular Therapeutix is seeking an experienced Clinical Development leader who thrives in a fast-paced environment and shares our passion for transforming the industry in developing and commercializing first-of-a-kind therapies. The successful candidate will deliver value by integrating advanced clinical decision making and approaches for our most crucial drug development deliverables, and build/lead a team of clinical professionals to strengthen our medical expertise and regulatory submissions. You will have the opportunity to work transversely across all Ocular projects in close collaboration with Project Leaders, R&D and Commercial experts, and lead the Clinical Development related activities for the company’s hydrogel based programs through clinical development stages.
Lead the Clinical Development team across planning, design, development, and implementation of clinical trials for all product candidates across all phases
Interface with KOLs to create clinical development strategies for various products
Provide pharmacovigilance oversight and manage timely reporting of safety signals to regulatory agencies
Guide Research and development/discovery team on decisions that have clinical components and implications
Maintain accountability for all relevant timelines and deliverables working closely with functional counterparts and colleagues integration of product and clinical development plans
Manage the writing of protocols, presentations, and publications (regulatory submissions, original peer-reviewed articles, abstracts)
Review key documents including protocols, investigator brochures, and informed consent forms, ISS, ISEs, etc.
Work closely with Clinical Operations to select between outsourcing and in-house approaches for Clinical Development activities
Maintain the highest quality clinical programs, following GCP and ICH guidelines
Help guide overall company strategy and trajectory
Provide leadership and mentorship to team members
Contribute to creating an open and collaborative working environment driven by common goals and competitive timelines.
MD or MD/PhD with 10+ years of industry experience; experience in a small to mid-sized biotech company is preferred
Ophthalmology clinical backgrounds preferred
Proven track record of drug development with Phase 1 through 3 trial experience preferred
Outstanding communication and leadership skills accompanied by a readiness to “roll up the sleeves” to contribute to team efforts
Excellent writing skills with a track record of publications and polished presentation skills to influence internal and external audiences
Ability to develop creative approaches to processes, practices, services, business models, and strategy
Takes personal accountability for outcomes and thrives on increasing levels of responsibility to move the business forward
Regulatory experience with Pre-INDs, INDs, CTAs, EOP 2 meetings and NDA/BLAs/MAA, both US and ex-US
Experience having managed significant accelerations and challenges in clinical programs
Additional Experience and Skills Preferred
Successful track record in clinical , or a related discipline in a project team setting, whether in academia or industry.
Advanced knowledge in the use of
Demonstrated ability to leverage relationships and networks in and outside of the company to drive the business forward and remove obstacles for delivering critical business results.
Strong collaboration and problem-solving skills to establish good working relationships with employees at all levels, to influence decision-making, provide feedback, devise and implement creative solutions to problems.
External Company Name: Ocular Therapeutix, Inc.
External Company URL: http://www.ocutx.com/
Street: 24 Crosby Drive