The Henry M. Jackson Foundation for the Advancement of Military Medicine is a global nonprofit organization created by Congress in 1983 to assist in accelerating the progress of military medicine. Our unmatched experience in military medical research makes us uniquely qualified to assist investigators and clinicians in managing scientific research. By providing exceptional program management services, we relieve the administrative burden associated with medical research, empowering researchers to make the medical discoveries our warfighters need.  

Our mission is to advance Military Medicine and our objectives are clear: to carry out medical research and education projects that provide answers and drive change while removing barriers to success; to serve as a trusted and responsive link between the military medical community, its private partners and American service members, veterans and civilians; to encourage engagement of the medical community for the mutual benefit of military and civilians, who benefit from this work. 

HJF is committed to supporting Military Medicine serving as the connective tissue between its industry partners and the research environment. 

We are driven to solve the biggest puzzles and hardest problems by using the resources necessary to support the mission. We anticipate needs, responding at the pace of change to focus on continually adding value to military medical research.

Industry: Research Services
Company Size: 1,001-5,000 employees

The Henry M. Jackson Foundation for the Advancement of Military Medicine

Savvy Admin PROD

**Job Description**

**Join the HJF Team!**

This position is contingent upon contract award.

HJF is seeking a **Senior Clinical Research Director (SCRD) **to perform research and/or development in collaboration with others for project. The Clinical Director will plan and support the execution of TBI Research and manage the implementation of clinical research protocols in addition to handle research findings to build capacity to support further expansion of programming.

This position will be in support of the **Traumatic Brain Injury Center of Excellence (TBICoE) ** at ~~Joint Base Lewis McChord, WA. ~~ The TBICoE is a branch of the Research Support Division in the Research and Engineering Directorate (R&E) of the Defense Health Agency (DHA). DHA is a Federal Program within the Department of Defense (DoD). TBICoE, known previously as the Defense and Veterans Brain Injury Center (DVBIC), has been congressionally mandated since 1992 and is currently a matrixed research, dissemination, and knowledge translation program, supporting warfighter brain health and readiness by advancing the traumatic brain injury state of the science and clinical standards.

TBICoE’s mission to support the warfighter is executed through subject matter experts embedded across DHA facilities with expertise in TBI clinical research investigations, surveillance, clinical tool development and training, cognitive monitoring and assessment, and dissemination of TBI tools, products, and education/training materials to DoD medical personnel, service members, including Guard, Reserve, and operational medics/corpsmen, veterans with TBI, and families/caregivers of the warfighter.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

This position is contingent upon contract award.

**Responsibilities**

- Coordinates and manages clinical research from the point of strategic visioning and development of the research agenda to proposal development, execution and distribution of findings.

- Supports implementation, communication, and ongoing execution of research, program evaluation and performance measurement efforts.

- Coordinates with program managers and site-specific investigators to prepare grant/funding applications, develop contracts with vendors, write progress reports for sponsors and track various aspects of the program related to research administration.

- Contributes to the development and modifications of study budgets and is responsible for budget compliance and development/tracking of protocol performance metrics.

- May include budgetary responsibility to include plan/forecast.

- May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

**Supervisory Responsibilities**

- Direct Supervisor: Direct authority to make decisions on the following: employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and directs work activities.

**Qualifications**

**Education and Experience**

- Doctoral Degree [MD, PhD, MD/PhD, or relevant terminal doctorate degree] in related health or medical field. Experience within clinically appropriate systems of care may be accepted in lieu of educational minimums.

- Minimum 5-10 years of training or experience in clinical and/or research activities in traumatic brain injury required.

- 5-10 years of experience in research as demonstrated by peer reviewed publications and presentations required.

- 2-5 years management experience preferred.

- Prior experience within the DoD/VA systems of care preferred. Must complete CITI/ HIPAA training.

- As applicable, maintains current license to practice in any one of the 50 states, the District of Columbia, Puerto Rico, Guam or the U.S. Virgin Islands, or any US territory that allows for the independent practice of clinical services. This license must be current and unrestricted (not subject to restriction pertaining to the scope, location, or type of practice ordinarily granted to other applicants for similar licenses in granting jurisdiction).

**Required Knowledge, Skills, And Abilities**

- Knowledge of DoD, federal and local regulations, and policies pertinent to research involving human subjects.

- Ability to function independently with a high degree of professionalism and clinical judgment required.

- Excellent interpersonal skills with the ability to interact with staff at all levels to foster collaborative research activities required.

- Excellent oral and written communication skills required. Ability to facilitate, present and translate information to diverse end users of research findings in small and large groups, inclusive of providers, scientists, line leaders, and other relevant TBI stakeholders, as well as the flexibility to re-prioritize quickly based on shifting gaps, taskers, leadership composition, and local/HQ requirements required.

- Must have a high level of competence in clinical investigations, research administration (e.g., budget management, project/grant management, personnel requirements, regulatory compliance, etc), and staff education on SOPs, policies, and best practices.

- Ability to effectively author and lead teams on professional, peer reviewed journal articles, manuscripts, research grant applications, posters and research reports required.

- Ability to work as part of a multidisciplinary health care team is required.

- The incumbent must be able to work comfortably with computer software, including Microsoft Office, as well as relevant statistical software.

- Knowledge and experience with MHS, combat/deployment issues, and psychological health issues in the military are highly desired.

- Knowledge and experience with brain injury is required.

- S/he must adhere to legal, professional, and ethical codes with respect to confidentiality and privacy.

- Demonstrated skill and experience in working with governance and advisory groups, bringing together diverse skills sets, abilities and personal and professional experiences to bear on the successful planning and execution of large-scale research projects.

- Demonstrated strategic thinking, organizational skills, and keen analytical ability.

- Knowledge of clinical research methodologies, with demonstrated experience in formulating research questions and hypotheses, developing logic models and theories of change, and selecting appropriate study designs, data sources, and measurement techniques.

- Demonstrated experience in directing mixed-method studies, including conduct of literature reviews, development, pilot-testing, and administration of data collection instruments and analysis and reporting of quantitative and qualitative data.

- Demonstrated ability to synthesize knowledge across a various field including medicine, psychology, and neuroscience.

- US Citizenship and the ability to obtain and maintain a T3/Secret Clearance, including background check and drug screening.

**Physical Capabilities**

- Lifting: Requires lifting materials up to 25 lbs.

- Ability to stand or sit at a computer for prolonged periods

**Work Environment**

- This position will take place primarily in an office setting.

**Compensation**

- The annual salary range for this position is $120,600-$180,000. Actual salary will be determined based on experience, education, etc.

**Benefits**

- HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

**Equal Opportunity Employer/Protected Veterans/Individuals With Disabilities**

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

~~Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer. ~~

Senior Clinical Research Director (SCRD)

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

**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.

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