Senior Clinical Research Director, Ophthalmology

Job Title: Senior Clinical Research Director, Ophthalmology

Location: Cambridge, MA  Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

The Senior Clinical Research Director (CRD) is an expert clinical lead for one or several indications in the Development of an R&D program and is responsible for leading clinical team(s) to deliver successful clinical trials for novel therapeutics for Ophthalmologic Diseases.  The role requires clinical leadership, organization skills, strategically and operationally focused, resourceful individual with capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple operational tasks.

We are looking for individuals with drive, curiosity, scientific mindset, and appreciation of teamwork with a diverse group of internal and external experts.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

The role of the Senior CRD is to:

• Provide ophthalmology focused medical and scientific expertise to the cross functional project team to conduct the clinical studies from early phases to LCM programs

• • Establish clinical development strategy and lead clinical team, collaborate with other medical and clinical scientific experts, clinical development scientists, in the project in collaboration with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory agency interactions

• Develop or contribute to the regulatory documentation for the project(s), provide clinical leadership to other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment)

• Provide appropriate medical input & clinical leadership for all activities related to study conduct such as responses to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators 

• Responsible for the clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA) and answers to questions from health authorities.  

• Serve as the medical expert in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other clinical team members, has the capacity to train them on the medical/scientific strategy by indication 

Scientific and Technical Expertise:

• • Has and maintains deep scientific, technical, and clinical expertise in ophthalmology and retinal diseases

  • Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest

  • Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products

  • Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders

Key responsibilities:

• • Designs the global clinical development strategy and generates the Clinical Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy according to the project progression and information available

  • Leads the clinical development including planned life cycle management (LCM)

  • Ongoing