Development Scientific Director
Cambridge, MassachusettsBridgewater, New Jersey Permanent Posted on Nov. 12, 2024 Closing on Mar. 11, 2025
Job Title: Development Scientific Director
Location: Cambridge, MA
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 Clinical Development Scientist is a key scientific lead for development programs. The role requires a well-organized, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple operational tasks.
This role will provide clinical scientific expertise for:
The clinical studies (except Clinical & Exploratory Pharmacology studies) and/or registries to be carried out by Clinical Sciences & Operations (eg: protocol, Key Results, Clinical Study Report).
Support other clinical development activities (e.g. pressure test and cluster feasibility, scientific review and validation of clinical data, study risk assessment).
Contribute to the clinical part of Common Technical Document for FDA & EMA submission, answers to questions from health authorities for submission dossier) for their selected project.
The individual will provide appropriate scientific input & support for all activities related to clinical studies such as protocol training, feasibility, scientific review of data, clinical scientific information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
The individual will be the scientific reference in the Clinical Study team, ensuring the scientific relevance of the clinical data.
He/she will have to interact with Global Project Head, The PV Rep, Regulatory and other key functional reps
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
Provide expertise and act as a reference for all clinical scientific operational activities related to the projects/studies he/she is assigned to
Write/contribute/review/QC/validate study related documents: clinical protocols, written subject information, trial disclosure form, Case report form, study plans (eg: study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigators Meetings). Contribute to publications and communications of results.
Collaborate and communicate appropriately with all stakeholders for optimal study execution, including but not limited to:
feasibility managers for feasibility preparation and validation of feasibility results
Clinical Research Directors, Clinical Scientists, Medical review team and Coding
Pharmacovigilance (GSO, CME) as regard to safety management and case processing
CTOMs, Biostatisticians
CSU medical advisors for the best knowledge of the study, compound, protocol
TA Experts, GPHs and medical affairs
CROs
Regulatory affairs
Provide input to the study extended synopsis and protocol based on feasibility pre-assessment, protocol complexity index and assist in determining associated cost.
Responsible to support the overall supervision/execution of clinical scientific validation/review of study data, including writing or supervision of study related documents (eg: medical review plan, guidelines, etc…).
May organize/contribute to Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (eg charter, presentations).
Provide clinical scientific answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team.
Secure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function.
Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc).
Interact with assigned Medical Writers to develop, review and finalize study protocols and reports.
Maintain clinical scientific expertise in the therapeutic domain, including very good understanding of underlying disease biology and translation to development programs, and contributing to disease biomarker plans. Maintain very good understanding of disease pathophysiology, disease subtypes and clinical management.
Collaborates with functions to ensure uniform, aligned operational approach (eg harmonizing study documents, ES, protocols, etc), as relevant, within a project, ensures leadership, builds consensus, coordinates action plans with other development colleagues and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to CSO and TA Heads, as relevant and shares relevant information within development and beyond (project teams, etc.).
Provide operational expertise to project clinical sub team, as needed.
Supports the drafting of the extended synopsis of studies and subsequent protocol that he/she will be responsible for, and contribute to the clinical development plans (CDP), review of Investigator’s brochure, the clinical sections of integrated development plans (IDP), and overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP and other regulations.
Assisted by related Sanofi functions (e.g. clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials.
Supports the team with defending the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable. The individual may provide input into strategies to increase understanding of the mechanism of action of the drug including but not limited to the identification of biomarkers. On an ad hoc basis the individual will be requested to contribute expertise to specific tasks such as the evaluation of potential in-licensing candidates.
About You
Experience:
Understanding of pharmaceutical product development and life cycle management gained through at least 2 years of development and clinical scientific experience
Very good scientific expertise
Very good expertise in clinical development and methodology of clinical studies
Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
Demonstrated capability to challenge decision and status quo with a risk-management approach
Ability to negotiate to ensure operational resources are available for continued clinical conduct
Fluency in written and spoken English
Very good Teaching skills, demonstrated ability to assist and train others
Ability to work within a matrix model.
Minimum Level of any Required Qualifications:
PhD in a Life Science or Health Science related field. English fluent (spoken and written)
At least 2 years in pharmaceutical industry or CRO, previous experience in clinical development
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
#vhd
Pursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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.