Clinical Research Director Jobs for OPT Students
Clinical Research Director roles are available to F-1 OPT students with advanced degrees in clinical research, life sciences, or public health. Most positions require STEM OPT eligibility, giving you up to 36 months of work authorization. Employers in this field, including pharmaceutical companies, CROs, and academic medical centers, regularly sponsor H-1B visas for qualified directors.
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Get Access To All JobsJob Title: Senior Clinical Research Director
Location: Cambridge, MA or Morristown, NJ
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. As the Senior Clinical Research Director (Senior CRD) within the RARE Therapeutic Area, you will be the expert clinical lead for one or several indications in the Development of an R&D program. The role requires medical leadership, organization skills and a strategically and operationally focused, resourceful individual. The Senior CRD shows capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self-motivation, solid analytical skills, and the ability to deliver multiple operational tasks. To support sustainable growth, Sanofi Global Development ambition is to be the industry-leading Development organization, using impactful therapeutic innovation that turns hope into reality for people. The RARE Therapeutic Area leads the development of therapies for rare inherited disorders by overseeing the portfolio of development projects and execution of the development programs through the multi-disciplinary Global Project Team (GPT). The Rare Neurometabolic Cluster oversees development projects and execution of the development programs of lysosomal storage with systemic and neurological manifestations, neuromuscular and neurodevelopmental disorders.
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
The role of the Senior CRD is to:
- Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs
- Collaborate with other medical and clinical scientific experts CRDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction
- Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…)
- Provide appropriate medical input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
- Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc…) and answers to questions from health authorities.
- Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other DMDs/DSDs/CSs, has the capacity to train them on the medical/scientific strategy by indication
Key Responsibilities Include
Leading the clinical development plan strategies:
- Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)
- Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
- Prepares Internal Governance documents and contributes to the medical aspects the TPP, TVP and other GPT documents related to one or several indications of the IDP in support of the GPH
- Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams
- Raise study or project-level issues to the project head and propose related corrective action plans
- Collaborates with external partners, regulators, scientific experts and internal stakeholders
- Provide operational expertise to project clinical sub team, as needed
- Evaluates relevant medical literature and status from competitive products
Lead, Support and oversee the execution of clinical development and studies activities
- Collaborate and communicate appropriately with all function stakeholders (e.g. clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement etc…), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
- Develop the abbreviated protocol, the final protocol and protocol amendments
- Develop/review the Core Study Informed Consent Form (CSICF)
- Develop/review Study committee Charters
- Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results
- Review and provide clinical input across different study documents Vendors RFPs, (e-)CRF,(e-) diary, (e-)CoA, etc
- Provide medical/clinical input to study-related documents such as study plans e.g. Study risk management plan, Monitoring and centralized monitoring plans
- Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings
- Answer to medical questions raised by HA, EC/IRBs, sites
- Ensure quality of clinical data through continuous data validation, blinded Data review on summary tables or electronic data visualization during clinical trial conduct (AE dedicated review, and Clinical Case review for safety data and statistical surveillance for efficacy data,…)
- Ensure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
- Lead the study specific committees (IDMC, steering com, adjudication …) with operational support
- Co-Develop the SAP in collaboration with biostats
- Responsible for key results preparation
- Develop/Review the clinical study report
Responsibilities Related To Regulatory And Safety Documents And Meetings
- Represent project in interactions with regulatory bodies, leads strategy and write clinical sections of the CTD, briefing docs and supports registration, labelling etc…
- Develop and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, DRMP, RMP
- Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
- Ensure clinical data meets all necessary regulatory standards
- Collaborate with the Patient Safety GSO to detect and document any safety signal
- Participates in Advisory Committee preparation
Scientific Data Evaluation And Authorship
- Participate and author manuscripts and abstracts
- Establish and maintains appropriate collaborations with knowledge experts or advisory boards
- Represent medical function on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for the therapeutic area and serves as the clinical advisor to research teams
Experience
About You
- At least 4 years previous experience in clinical development in pharmaceutical industry or a CRO or medical experience in clinical development in an Healthcare institution
Soft Skills
- Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
- Excellent problem solving capability
- Demonstrated capability to challenge decision and status quo with a risk-management approach
- Quality-focused, able to develop good practices, using a critical data-driven and risk management approach
- Multiple tasks handling and prioritization
- Ability to negotiate to ensure operational resources are available for continued clinical conduct
- Mentoring skills and evaluation of resources performance capability
- Ability to work within a matrix model
- International/intercultural working skills
- Open-minded to apply new digital solutions
Technical Skills
- Understanding of pharmaceutical product development and life cycle management
- Very good Scientific and medical/clinical expertise
- Very good expertise in clinical development and methodology of clinical studies
- Acquired expertise (by training or experience) of interaction with Health Authorities
Education
- Medical Doctor (MD) preferred: GP or specialist; training in pediatrics or pediatric neurology is a plus
Languages
- English fluent (spoken and written)
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.
Job Title: Senior Clinical Research Director
Location: Cambridge, MA or Morristown, NJ
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. As the Senior Clinical Research Director (Senior CRD) within the RARE Therapeutic Area, you will be the expert clinical lead for one or several indications in the Development of an R&D program. The role requires medical leadership, organization skills and a strategically and operationally focused, resourceful individual. The Senior CRD shows capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self-motivation, solid analytical skills, and the ability to deliver multiple operational tasks. To support sustainable growth, Sanofi Global Development ambition is to be the industry-leading Development organization, using impactful therapeutic innovation that turns hope into reality for people. The RARE Therapeutic Area leads the development of therapies for rare inherited disorders by overseeing the portfolio of development projects and execution of the development programs through the multi-disciplinary Global Project Team (GPT). The Rare Neurometabolic Cluster oversees development projects and execution of the development programs of lysosomal storage with systemic and neurological manifestations, neuromuscular and neurodevelopmental disorders.
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
The role of the Senior CRD is to:
- Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs
- Collaborate with other medical and clinical scientific experts CRDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction
- Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc…)
- Provide appropriate medical input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
- Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc…) and answers to questions from health authorities.
- Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other DMDs/DSDs/CSs, has the capacity to train them on the medical/scientific strategy by indication
Key Responsibilities Include
Leading the clinical development plan strategies:
- Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)
- Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
- Prepares Internal Governance documents and contributes to the medical aspects the TPP, TVP and other GPT documents related to one or several indications of the IDP in support of the GPH
- Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams
- Raise study or project-level issues to the project head and propose related corrective action plans
- Collaborates with external partners, regulators, scientific experts and internal stakeholders
- Provide operational expertise to project clinical sub team, as needed
- Evaluates relevant medical literature and status from competitive products
Lead, Support and oversee the execution of clinical development and studies activities
- Collaborate and communicate appropriately with all function stakeholders (e.g. clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement etc…), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
- Develop the abbreviated protocol, the final protocol and protocol amendments
- Develop/review the Core Study Informed Consent Form (CSICF)
- Develop/review Study committee Charters
- Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results
- Review and provide clinical input across different study documents Vendors RFPs, (e-)CRF,(e-) diary, (e-)CoA, etc
- Provide medical/clinical input to study-related documents such as study plans e.g. Study risk management plan, Monitoring and centralized monitoring plans
- Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings
- Answer to medical questions raised by HA, EC/IRBs, sites
- Ensure quality of clinical data through continuous data validation, blinded Data review on summary tables or electronic data visualization during clinical trial conduct (AE dedicated review, and Clinical Case review for safety data and statistical surveillance for efficacy data,…)
- Ensure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
- Lead the study specific committees (IDMC, steering com, adjudication …) with operational support
- Co-Develop the SAP in collaboration with biostats
- Responsible for key results preparation
- Develop/Review the clinical study report
Responsibilities Related To Regulatory And Safety Documents And Meetings
- Represent project in interactions with regulatory bodies, leads strategy and write clinical sections of the CTD, briefing docs and supports registration, labelling etc…
- Develop and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, DRMP, RMP
- Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
- Ensure clinical data meets all necessary regulatory standards
- Collaborate with the Patient Safety GSO to detect and document any safety signal
- Participates in Advisory Committee preparation
Scientific Data Evaluation And Authorship
- Participate and author manuscripts and abstracts
- Establish and maintains appropriate collaborations with knowledge experts or advisory boards
- Represent medical function on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for the therapeutic area and serves as the clinical advisor to research teams
Experience
About You
- At least 4 years previous experience in clinical development in pharmaceutical industry or a CRO or medical experience in clinical development in an Healthcare institution
Soft Skills
- Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
- Excellent problem solving capability
- Demonstrated capability to challenge decision and status quo with a risk-management approach
- Quality-focused, able to develop good practices, using a critical data-driven and risk management approach
- Multiple tasks handling and prioritization
- Ability to negotiate to ensure operational resources are available for continued clinical conduct
- Mentoring skills and evaluation of resources performance capability
- Ability to work within a matrix model
- International/intercultural working skills
- Open-minded to apply new digital solutions
Technical Skills
- Understanding of pharmaceutical product development and life cycle management
- Very good Scientific and medical/clinical expertise
- Very good expertise in clinical development and methodology of clinical studies
- Acquired expertise (by training or experience) of interaction with Health Authorities
Education
- Medical Doctor (MD) preferred: GP or specialist; training in pediatrics or pediatric neurology is a plus
Languages
- English fluent (spoken and written)
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.
How to Get Visa Sponsorship in Clinical Research Director
Target STEM-designated degree holders
If your degree is in a STEM field such as biomedical sciences, public health, or bioinformatics, confirm your STEM OPT extension eligibility before applying. This gives you 36 months total, making you far more attractive to employers evaluating H-1B sponsorship timelines.
Focus on CROs and large pharma sponsors
Contract research organizations like ICON, PAREXEL, and Syneos Health, along with major pharmaceutical companies, have established immigration programs and regularly sponsor H-1B visas. These employers are more likely to absorb the cost and process complexity of sponsoring a Clinical Research Director.
Lead with regulatory and protocol experience
Clinical Research Directors are evaluated heavily on FDA regulatory knowledge, protocol development, and Phase II through IV trial oversight. Quantify your experience with the number of trials managed, therapeutic areas covered, and regulatory submissions contributed to in your application materials.
Apply before your OPT expires, not after
H-1B cap-subject petitions are filed in April for an October 1 start. Map your OPT expiration date against this calendar now. If your OPT ends before October, ask employers about cap-exempt institutions or whether they can bridge the gap with a timely filed petition.
Highlight cross-functional leadership directly
Director-level roles require demonstrated experience managing clinical operations teams, vendor relationships, and multi-site coordination. Employers sponsoring at this level expect evidence of leadership, not just technical skill. Frame your resume around scope of responsibility, not just task completion.
Discuss sponsorship early in the interview process
Do not wait until an offer to raise your visa status. Bring it up after the first substantive interview, framed around your timeline. Employers who cannot sponsor will tell you, saving weeks of time you cannot afford to waste while on OPT.
Clinical Research Director jobs are hiring across the US. Find yours.
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Get Access To All JobsFrequently Asked Questions
Can F-1 OPT students work as a Clinical Research Director?
Yes. F-1 students authorized for OPT can work as a Clinical Research Director as long as the role directly relates to their field of study. Most directors hold degrees in clinical research, life sciences, public health, or a related STEM field, and those degrees typically qualify for STEM OPT extension, giving up to 36 months of total work authorization.
Do Clinical Research Director roles qualify for STEM OPT extension?
In most cases, yes. If your degree is in a STEM-designated field such as biomedical sciences, bioinformatics, epidemiology, or clinical research management, and the director role is directly related to that field of study, you are likely eligible for the 24-month STEM OPT extension. Confirm your degree's STEM designation with your DSO before applying.
Which employers are most likely to sponsor H-1B visas for Clinical Research Directors?
Large pharmaceutical companies, contract research organizations, and academic medical centers with active clinical programs are the most consistent H-1B sponsors at the director level. These organizations have legal infrastructure and budget to support sponsorship. Browse Clinical Research Director roles with visa sponsorship on Migrate Mate to identify employers actively hiring international candidates.
What documents do I need to work as a Clinical Research Director on OPT?
You need a valid EAD card reflecting your authorized OPT period, a valid F-1 visa stamp for international travel, your most recent I-20 with OPT authorization noted by your DSO, and a valid passport. Your employer will also need to verify your work authorization through Form I-9 on or before your first day of employment.
What happens to my OPT status if I am terminated from a Clinical Research Director role?
F-1 OPT students have a 60-day unemployment buffer. If your Clinical Research Director position ends involuntarily, you have 60 days to secure new employment in a related field before your status is at risk. You cannot accumulate more than 90 days of total unemployment across your full OPT period, including the STEM extension if applicable.
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