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 assessment of the product benefit–risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team

  • Implements strategies to identify, monitor and resolve clinical program/trial issues.

  • Responsible for medical monitoring for a study or clinical program as well as reviewing and monitoring study data.

  • Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/communications for the study team and other stakeholders

  • Prepares/reviews key clinical documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD).

  • Provides clinical input to Statistical Analysis Plans (SAP), Target Product Profile (TPP) and Risk Management Plan

  • Writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees and investigators

  • Reviews Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the project

  • Lead the medical/clinical assessment of license-in opportunities, as needed

  • Manage other study physicians (CRDs) and clinical scientists in the same program, as needed

• Author or co-author manuscripts and abstracts

• Establishes and maintains appropriate collaborations with key opinion leaders or advisory boards

• Serves as clinical team leader/representative at the global project team(s), regulatory agency meetings, Steering committees, benefit-risk assessment committee, and at the submission task force.

About You

Basic Qualifications:

• Medical Doctor (MD) and ophthalmology residency training required, fellowship training highly preferred

• More than 7 years of clinical trial and/or clinical development experience

• Fluent in English (verbal and written)

Preferred Qualifications:

• Board certified or eligible in Ophthalmology

• Strong scientific and academic background with deep understanding of retina and eye diseases

• Clinical trial or pharmaceutical experience in ophthalmology

• Knowledge of drug development, ocular gene therapy, regulatory strategy

• Good networking ability in cross-cultural environment

• Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization

• Performance oriented with ability to work along agreed timelines and a focus on strategy and execution

• Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.