6,714 Clinical Research Director jobs in the United States

Job Title: Clinical Research Director

Location : Morristown, NJ Cambridge, MA

About the Job

Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

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 Dermatology,  incorporate new methodologies and pro-actively progress study execution. 

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:

• 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 dermatology.  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 Dermatology.

• 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 dermatology 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 dermatology.

• 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
#LI-SA
#LI-Onsite
 #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.

Job Title: Clinical Research Director

Location: Morristown, NJ Cambridge, MA

About the Job

Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

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 Dermatology, incorporate new methodologies and pro-actively progress study execution.

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:

• 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 dermatology. 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 Dermatology.

• 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 dermatology 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 dermatology.

• 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
#LI-SA
#LI-Onsite
#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.

Job Title: Clinical Research Director

Location: Morristown, NJ Cambridge, MA

About the Job

Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

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 Dermatology, incorporate new methodologies and pro-actively progress study execution.

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:

• 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 dermatology. 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 Dermatology.

• 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 dermatology 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 dermatology.

• 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
#LI-SA
#LI-Onsite
#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.

Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

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 Dermatology, incorporate new methodologies and pro-actively progress study execution.

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?

• 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.
• 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.

• This position requires a strong scientific and clinical foundation in dermatology. 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 Dermatology.
• 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.

Basic Qualifications:

• Medical Doctor. Should be board certified or equivalent in dermatology 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 dermatology.
• 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).

• 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

• Drive Study Execution : Manage all aspects of clinical studies from initiation to closure, including site selection, product management, and communication with study sites. Strong project management skills are essential to tracking milestones and achieving targets.
• Support Protocol Development : Contribute to the creation of study protocols in compliance with regulatory standards. Your expertise will help ensure protocols align with clinical operations and regulatory requirements, meet the highest industry standards, and contribute to a strong relationship between Glaukos and our investigation partners.
• Collaborate Cross-Functionally : Partner with Clinical, Regulatory, R&D, and Marketing teams to design and implement successful clinical research programs. Your experience in managing multi-disciplinary projects will drive innovation and seamless integration.
• Develop Budgets & Contracts : Lead the development of clinical study site budgets, negotiate contracts, and manage vendors. Your ability to manage complex budgets and maintain vendor relationships will ensure smooth study operations.
• Lead and Develop High-Performing Teams : Build and develop a team of clinical research professionals, fostering a culture of excellence. Prior leadership experience in clinical research is crucial to guide the team and ensure top performance.
• Drive Enrollment : Proactively identify and address enrollment challenges, using your creative problem-solving skills to ensure enrollment targets are met on time.
• Ensure Regulatory Compliance : Prepare and submit reports external and internal stakeholders, maintaining a deep understanding of industry regulations to ensure compliance throughout study processes.
• Contribute to Process Development : Collaborate with Clinical Compliance to refine and develop SOPs and other department processes, leveraging your experience to ensure clinical operations are efficient and effective.

• Bachelor's degree required, master's and/or other advanced degree preferred in biological sciences, nursing, or health-related discipline.
• 12+ years of relevant clinical research experience, preferably in ophthalmology and medical devices, with 9+ years of direct study management.
• Minimum 4 years of supervisory experience in clinical settings.
• Combination products or pharmaceuticals necessary to be considered.
• Experience in ophthalmology and surgical procedures required.
• Proven leadership in managing multiple clinical trials, including CRA and vendor management, meeting milestones, and managing timelines.
• Strong skills in study auditing, site monitoring, adverse event reporting, and training CRAs.
• Expertise in negotiating/executing site and vendor budgets, analyzing study data, and preparing study reports.
• Experience with study design, protocol writing, and clinical study documentation while successfully problem-solving and cross-functionally collaborating with internal and external stakeholders.
• Ability to write SOPs and develop processes for improved quality and efficiency, with a willingness to travel as needed.

• Assists with development and writing of study protocols. Ensures protocols are in compliance with appropriate regulatory requirements and clinical operation written procedures.
• Responsible for the development of the Clinical Investigator's Brochure (if applicable).
• Responsible for the development of the study Case Report Forms and associated data collection documents.
• Responsible for the development of the Informed Consent Form template, ensuring all regulatory requirements are addressed.
• Responsible for the development of the study Monitoring Plan, patient recruitment materials, and all other study documents.
• Assists with development of clinical study site budget.
• Develops training documents for sites, team members, and surgeries. Train team members on clinical study requirements.
• Assists with project planning, problem resolution, and investigator meetings as needed.
• Provides proactive leadership in identifying enrollment issues and recommending solutions so that enrollment targets are met.
• Oversees all aspects of clinical study execution:
  * Manages clinical study product, including inventory projections, requests for shipping (including verification of essential documents), and accountability
  * Assists with site selection
  * Project manages from study initiation through study closure, including timeline development, milestone achievement, and budget projections
  * Oversees site monitoring/management activities of assigned CRAs. Reviews adverse event data, surgical data, and clinical study product accountability and alerts Regulatory Affairs, Clinical management, and Medical Monitor as needed to ensure UADEs and potential product issues are properly reported
  * Communicates with sites, including leading enrollment teleconferences, organizing investigator meetings, and traveling to sites as needed
  * Negotiates budgets with sites, assists with site contract execution, and administers grant payments.
  * Assists with ClinicalTrials.gov as needed
  * Assists with selection of vendors
• Assists with development of budgets and contracts with vendors
• Manages vendors to ensure proper study execution
• Communicates with vendors as main study contact
• Assists with development of clinical study reports (communications/reports to regulatory bodies, DSMB meetings, interim and final reports)
• Participates in the preparation of regulatory submissions as needed.
• Submits reports to IRBs as required.
• Develops and provides progress reports to management as needed.
• Assists with investigator meetings at glaucoma-related conferences as needed.
• Responsible for process development within the clinical department in order to ensure quality, effective, and efficient clinical operations:
  * Writes SOPs and associated documents or reviews documents written by other department employees
  * Develops processes to assess compliance with SOPs and study processes, including metrics
• Hires, trains, and supervises employees/contractors in order to ensure quality, effectiveness and productivity.
• Assigns projects with clear milestones and monitors progress to ensure timely completion.
• Provides supervisor of assigned team members with feedback on performance and assists with development through assigned study tasks.
• Assists employees with developmental needs and provides development opportunities
• Develops relationships with key opinion leaders and clinical investigators.
• Stays abreast of recent developments in ophthalmology and attends ophthalmic congresses on a periodic basis.

Job Title: Clinical Research Director - RBD

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. 

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

 Genzyme Corporation (a Sanofi company) 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.

The Clinical Research Director (CRD) provides medical and scientific expertise to the creation and implementation of global clinical development plans and other activities within Sanofi Genzyme related to the corporate mission of developing novel and valued therapeutics for patients with high unmet needs. 

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 CRD is expected to be a principal team member within the development group.  He/she provides medical and scientific leadership in the development of new therapies.  The CRD is responsible for the clinical aspects of the Global Clinical Development Plan (GCDP) and is accountable for the appropriate design, execution, and analyses of clinical trials within the GCDP. 

• The CRD will become an expert in the disease and experimental therapy for which he/she is responsible.  This expertise should be developed and maintained through background medical education, proficiency in current scientific literature, attendance and participation in scientific conferences and relationships with external experts. The CRD will maintain up to date knowledge of practices and scientific literature in the therapeutic area and communicate developments to appropriate internal staff. 

• The CRD works with the Clinical Science Operation (CSO) team to implement selected clinical trial(s) within the GCDP, including study initiation, study conduct and preparation of study reports.

• The CRD leads the Clinical Development Subteam (CDST) working closely with the CSO Project Lead (PL) and is accountable for the development of the clinical development strategy.  In this role, the CRD provides clinical input and leadership into the activities of this team in close collaboration with the Global Project Head (GPH) and Project Manager (PM), including the relevant components of the GCDP in accordance with the product profile and corporate goals.

• In the creation and implementation of the GCDP, the CRD has a leadership role in partnership with other members of the CDST (i.e., GPH, CSO PL, regulatory, statistics, and PM)

• The CRD will lead the preparation of clinical documents/reports for regulatory submission and will attend meetings with regulatory authorities.

• The CRD will work in conjunction with the Commercial and Medical Affairs to support the creation of the product value proposition and global product positioning.  

• In support of licensing and acquisition activities, the CRD will work in concert with business development and provide medical due diligence on opportunities.

• The CRD will liaise with the Medical Affairs group to contribute to activities such as review and approval of investigator sponsored studies, contribution to and review of manuscripts that involve Sanofi sponsored studies.

• The CRD will liaise with the Research group in the therapeutic area, contributing to the overall science discovery strategy and providing medical assessment of disease and therapeutic targets.

About You

Basic Qualifications:

• MD

• 5 + years of pharmaceutical/biotechnology industry or combined industry/ academic experience, with experience in clinical trials

• A working knowledge of GCP

• Preferred  Qualifications:

• Specialization in hematology preferred

• Academic experience as a principal investigator a plus

• Strong analytic thinking and the ability to assess scientific data and medical literature

• Excellent written and verbal communication skills.  Experience writing abstracts/manuscripts/study reports strongly desired

• Collaborative team work ethic. 

• Ability to work and lead a matrix team

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

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.