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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.

ID: 2020-1368

External Company Name: Ocular Therapeutix, Inc.

External Company URL: http://www.ocutx.com/

Street: 24 Crosby Drive

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