Senior Clinical Research Director, Ophthalmology
Bridgewater, New JerseyCambridge, Massachusetts Permanent Date posted 21/06/2024
About the Job
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?
The Senior Clinical Research Director (SCRD) 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, the 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.
Main responsibilities:
- Provide medical and scientific expertise to the cross functional project team to conduct the clinical studies from early phases to LCM program
- Develop 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
- 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
- Ability to work onsite 2 to 3 days per week per Hybrid working policy
Basic Qualifications:
- Medical Doctor (MD) and ophthalmology residency training required, retina and/or uveitis fellowship training highly preferred
- More than 5 years of clinical and/or clinical development experience, or more than 7 years industry experience within the field of ophthalmology and retinal diseases
- Fluent in English (verbal and written)
- Ability to work onsite 2 to 3 days per week per Hybrid working policy
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.
#GD-SA
#LI-SA
#LI-Onsite
You have not viewed any jobs yet.
You have not saved any jobs yet.
Sanofi careers in the US
Join our US team and get expert mentorship and training platforms, while helping to shape our culture. Bring your passion and energy and use your skills to help create vaccines and medicines that halve the time from discovery to therapy.
Find out more about this location
Experience possibility
-
-
Cambridge Crossing
We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.
-
Innovation in Action
Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.
-
Sustainable and Green
Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.
-
Sanofi’s AI Centre of Excellence in Toronto
The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.
-
Ama
Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.
-
Sanofi Canada's Philanthropic Efforts
By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.
-
Emmanuel
Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.
-
Dimitrije
Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.
-
Ziv
Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.
-
When you grow, we all grow
We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.
-
Build a career with purpose
Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.
-
Bolder, better futures
Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.
-
Our locations
We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.
-
Sanofi Stories
At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.
-
Sanofi at Cambridge Crossing
Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.
-
Why Sanofi
Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.
-
Our people & culture
We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.
-
Sanofi's Postdoctoral Program
Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.
-
Physician Careers at Sanofi
At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.
-
AI Centre of Excellence
The AI Centre of Excellence at Sanofi is a unique data-driven team based in Downtown Toronto. We pride ourselves on being data-obsessed and highly focused on using state-of-the-art technologies to drive global impact.
What could we achieve together?
Want to join our Global Talent Community? Every Sanofian works on projects that truly make a difference to people’s lives.
What could you achieve? Sign up today and discover our latest opportunities as soon as they’re available.