BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.

Industry: Internet News
Company Size: 11-50 employees

BioSpace

Savvy Admin PROD

**Job title: **Senior Clinical Research Director, Rare Disease

**Location: **Cambridge, MA / Morristown, NJ

**About The Job**

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, youll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs.

**Position Overview**

The Senior Clinical Research Director (sCRD), Rare Disease, is a senior scientific and clinical leader responsible for shaping and executing clinical development strategy for assigned rare disease programs driving them from early development through registration with a patient-centric focus.

The sCRD serves as a recognized scientific authority within the Rare Disease TA, championing clinical excellence, challenging conventional approaches, and advancing Sanofi's mission to deliver transformative therapies to underserved patients.

**Key Responsibilities**

- Clinical Development Strategy & Execution

- Lead design and authorship of study synopses, CDPs, and clinical sections of IDPs

- Oversee end-to-end trial execution through cross-functional units, ensuring GCP and regulatory compliance

- Define and manage timelines, budgets, and risk mitigation strategies with Clinical Operations, Project Management, and Procurement

- Serve as strategic clinical lead and medical spokesperson within the Global Project Team, Protocol Review Committee and Executive Leadership

- Contribute to biomarker identification and provide due diligence support for business development opportunities

Scientific Leadership

- Maintain deep expertise in internal medicine, metabolic diseases, nephrology and rare disease biology

- Integrate preclinical data, clinical pharmacology, and competitive intelligence to inform strategy

- Champion innovative trial designs adaptive, natural history, and real-world evidence appropriate for rare disease contexts

- Influence product value proposition through evidence-based input on unmet needs and development approaches

Regulatory Strategy

- Lead programs at key regulatory interactions (FDA, EMA, PMDA) as primary medical spokesperson

- Develop engagement strategies for pre-IND, End-of-Phase meetings, and Advisory Committee preparations

- Support label development, registration submissions, and post-approval modifications

- Ensure all activities comply with FDA, EMA, CHMP, ICH guidance and Sanofi policies

External Engagement & Dissemination

- Drive timely publication of clinical data in peer-reviewed journals and at scientific congresses

- Lead advisory board meetings and maintain strategic relationships with KOLs, patient advocacy organizations, and rare disease consortia

Cross-Functional Collaboration

- Align cross-functional stakeholders around a unified development vision; present CDPs to governance and senior leadership

- Partner with Medical Affairs, Biostatistics, Translational Medicine, Regulatory, Market Access, and Commercial functions

- Mentor Clinical Research Directors and Clinical Scientists and contribute to talent development within the Rare Disease TA

**Required Qualifications**

**Education: ** MD required; MD/PhD strongly preferred; medical degree from LCME-accredited or equivalent institution

**Experience: ** 10+ years in drug development, or 10+ years pharmaceutical/biotech industry experience in clinical development

**Rare Disease: ** Demonstrated experience with orphan drug frameworks and small patient population trial design

**Technical Skills: ** Expertise in clinical pharmacology, biomarker strategy, benefit-risk assessment, and innovative trial designs

**Leadership: ** Proven ability to lead cross-functional global teams without direct authority; strong negotiation and decision-making skills

**Communication: ** Exceptional written and verbal English; ability to present to scientific, regulatory, executive, and patient audiences

**Preferred Qualifications**

- Board certification in metabolic medicine, medical genetics, nephrology, or cardiology

- Direct experience with lysosomal storage disorders, enzyme replacement therapy, or gene therapy

- Prior experience as medical spokesperson in FDA/EMA meetings

- Familiarity with real-world evidence (RWE) in rare disease regulatory submissions

- Peer-reviewed publication record in the relevant therapeutic area

- Experience with business development and scientific due diligence

**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 its 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-SG

#vhd

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.

Senior Clinical Research Director, Rare Disease

**Job Title: **Clinical Research Directors

**Location: **Morristown, NJ Cambridge, MA

**About The Job**

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Gastroenterology, incorporate new methodologies and pro-actively progress study execution.

**About Sanofi**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

**Main Responsibilities**

- Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.

- Advance the CDP through internal management review.

- Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol.

- Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations.

- Review documents supporting clinical development such as Investigators brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.

- Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation).

- Contribute to data review, interpretation and publication of clinical study results.

- Represent Clinical Development at Health Authorities and incorporating advise into development strategy.

- Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program.

- Align company position on clinical strategy with partner in alliance projects.

- Translate biology into clinic in close collaboration with research and translational medicine.

- Evaluate clinical aspects of business development opportunities as needed.

- Apply high ethical standards and work with integrity.

**Scientific And Technical Expertise**

- This position requires a strong scientific and clinical foundation in gastroenterology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.

- Be experienced in advancing assets from discovery into clinical development.

- Have experience in novel approaches in translational medicine.

- Have and maintain deep scientific, technical and clinical knowledge in Gastroenterology.

- Demonstrated problem solving skills.

- Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area.

- Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome.

- Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods.

- Understand the competitive environment.

- Have established connections within the medical field of their expertise.

- Have a credible publication record.

**About You**

**Basic Qualifications:**

- Medical Doctor. Should be board certified or equivalent in gastroenterology or allergy/immunology.

- Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent.

- More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of gastroenterology.

- Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred.

- Knowledge of drug development preferred.

- Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment.

- 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.

- Fluent in English (verbal and written communication).

**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 its 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

#vhd

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.

Clinical Research Director

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. 

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms

Industry: Fabrication de produits pharmaceutiques
Company Size: + de 10 000 employés

Sanofi

**Job Title **:~~Junior Clinical scientist~~

- Location: Cambridge, MA

**About The Job**

The Junior Clinical Scientist plays a vital role in advancing clinical research by ensuring scientific rigor, data quality, and regulatory compliance throughout the study lifecycle. Reporting to the Clinical Research Director, this position serves as a critical bridge between scientific expertise and operational excellence, supporting the delivery of high-quality clinical trials that bring innovative treatments to patients.

As a Junior Clinical Scientist, you will be responsible for preparing and reviewing essential study documents, implementing risk-based monitoring strategies, and coordinating key stakeholders including investigators, Health Authorities, and expert committees. You'll leverage your scientific background and analytical mindset to proactively identify risks, ensure data integrity, and streamline processes across the clinical development continuum—from protocol design through study completion.

This role offers the opportunity to develop deep therapeutic area expertise while working with international teams and cutting-edge digital tools. You'll contribute directly to the quality and efficiency of clinical trials, helping to accelerate the path from research to life-changing medicines for patients worldwide.

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

**About Sanofi**

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

**Main Responsibilities**

- Contributes to preparation and/or review of any documents related to the studies and requiring a scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study reports, committee charters, protocol registration form, redacted protocol, lay summary …).

- Supports CRD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project.

- Contributes to the definition of the critical data/processes/predefined deviations list, risks and Quality tolerance limits identification and monitoring, to implement/develop related sections of the study risk management plan.

- Is involved in the update of study documents, eCRF adequacy with protocols/protocol amendments and helps in rationalizing and documenting the data collection needs quantitatively and qualitatively and decreasing the complexity.

- Develops study specific training material and participates to the Investigators, Study Team, and monitoring team training on medical information.

- Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved in study data validation and review processes, support the CRD for the Clinical Case review (safety events reported to GPV or safety events of special interest), notably to anticipate and prevent last minute queries or backlog and smoothen the process.

- Supports CRD in implementing, managing, organizing, and conducting Steering committees, Data Monitoring Committees, Adjudication Committee meetings.

**About You**

Basic Qualifications:

- Bachelor's degree in a scientific discipline with a minimum of 1 year of training/work experience considered; Ph.D., Pharm.D., M.D., or similar advanced degree preferred, with scientific expertise or strong interest and ability to learn in the domain of assigned study/project.

- Leadership to give directions and organize the activities on behalf of the Clinical Research Director.

- Well organized with the ability to handle multiple tasks and prioritize, working autonomously and efficiently providing status reports, quality focused, able to develop good practices, using a critical data-driven and risk management approach.

- Ability to analyze and interpret data-driven decision dashboards as well as familiar with digital tools such as data analytics or agility to use them.

- Ability to synthesize the information and good presentation skills, to anticipate and timely escalate issues and to execute action plans.

- Team and results oriented.

- Great communication skills (verbal and written), experience of working internationally with Strong English skills (verbal and written if English is not the native language.

**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.

- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

- Help improve the lives of millions of people globally by making drug development quicker and more effective.

- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

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

#vhd

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.

Junior Clinical scientist

**Job Title: **Clinical Research Directors

**Location: **Morristown, NJ Cambridge, MA

**About The Job**

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Gastroenterology, incorporate new methodologies and pro-actively Progress study execution.

**About Sanofi**

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

**Main Responsibilities**

- Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.

- Advance the CDP through internal management review.

- Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol.

- Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations.

- Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.

- Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation).

- Contribute to data review, interpretation and publication of clinical study results.

- Represent Clinical Development at Health Authorities and incorporating advise into development strategy.

- Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program.

- Align company position on clinical strategy with partner in alliance projects.

- Translate biology into clinic in close collaboration with research and translational medicine.

- Evaluate clinical aspects of business development opportunities as needed.

- Apply high ethical standards and work with integrity.

**Scientific And Technical Expertise**

- This position requires a strong scientific and clinical foundation in gastroenterology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.

- Be experienced in advancing assets from discovery into clinical development.

- Have experience in novel approaches in translational medicine.

- Have and maintain deep scientific, technical and clinical knowledge in Gastroenterology.

- Demonstrated problem solving skills.

- Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area.

- Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome.

- Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods.

- Understand the competitive environment.

- Have established connections within the medical field of their expertise.

- Have a credible publication record.

**About You**

**Basic Qualifications:**

- Medical Doctor. Should be board certified or equivalent in gastroenterology or allergy/immunology.

- Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent.

- More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of gastroenterology.

- Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred.

- Knowledge of drug development preferred.

- Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment.

- 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.

- Fluent in English (verbal and written communication).

**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

#vhd

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.

Find Clinical Research Director jobs in Cambridge, MA with Savvy's AI Recruiter. Browse opportunities from top companies and get matched with roles that match your skills using our intelligent recruitment system.