Research Director Jobs for OPT Students
Research Director roles are highly compatible with OPT authorization, including the 24-month STEM extension available to graduates in fields like social sciences, life sciences, and engineering. Most positions require a master's or doctoral degree, which works in your favor when demonstrating the specialty occupation standard employers need to support future H-1B sponsorship.
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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 Research Director
Lead with your research credentials upfront
Research Director roles are credential-heavy. Highlight your graduate degree, published work, and funded projects in your first contact with employers. Hiring committees evaluate academic pedigree early, so front-loading your qualifications removes friction before OPT even comes up.
Target institutions with established OPT hiring pipelines
Universities, research hospitals, think tanks, and federal contractors hire OPT students regularly and have HR teams familiar with the process. These employers are far less likely to withdraw an offer due to authorization questions than companies encountering OPT for the first time.
Clarify your STEM OPT eligibility before applying
If your degree is in a STEM-designated field, confirm your eligibility for the 24-month extension before interviews. Being able to tell an employer you have up to three years of work authorization significantly improves your chances of advancing past initial screening conversations.
Position H-1B sponsorship as a low-friction next step
Research Director candidates often hold doctoral degrees in specialty fields, which makes H-1B eligibility straightforward. Frame future sponsorship as a simple continuation of your employment, not an unknown risk. Employers are more receptive when you can explain the process with confidence.
Document your research impact with measurable outcomes
Grants secured, studies published, teams managed, and programs built all signal leadership capacity. Quantifying your research impact reduces employer hesitation about sponsoring someone in a senior role. Numbers and outcomes outperform job descriptions when you're asking an employer to invest in your visa.
Engage your university's international office proactively
Your DSO can provide employer support letters, answer HR questions directly, and help prevent misunderstandings about OPT conditions. Connecting your prospective employer with your international office early removes the most common reason research institutions delay or cancel OPT job offers.
Research Director jobs are hiring across the US. Find yours.
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Get Access To All JobsFrequently Asked Questions
Can I work as a Research Director on OPT?
Yes, Research Director roles are fully eligible for OPT work authorization as long as the position is directly related to your field of study. Because this is a senior leadership role, your degree should align with the research domain you'll be directing. A public health graduate directing epidemiological research, for example, satisfies the relatedness requirement without issue.
Does a Research Director role qualify for the STEM OPT extension?
It depends on your degree, not the job title. If you graduated from a STEM-designated program, such as data science, biomedical engineering, or computer science, and your Research Director role applies that training, you're eligible for the 24-month STEM extension. The extension is tied to your CIP code, so verify your program's designation with your DSO before assuming eligibility.
What types of employers hire Research Directors on OPT?
Universities, research hospitals, government-affiliated research centers, think tanks, and large corporations with dedicated R&D divisions are the most common. These organizations hire OPT students with enough regularity that their HR and legal teams understand the authorization requirements. You can browse Research Director roles open to OPT candidates on Migrate Mate, which filters specifically for visa-friendly employers.
Will employers see a Research Director as too senior a role to sponsor?
Not typically. Research Director positions usually require advanced degrees in a specific discipline, which makes them strong candidates for H-1B classification as specialty occupations. Employers in academia and research are accustomed to sponsoring senior scientists and program leaders. The key is demonstrating that your qualifications match the scope of the role, which makes the sponsorship case straightforward for their legal team.
What should I do if my OPT expires before my employer completes H-1B sponsorship?
If you're on STEM OPT and your employer files an H-1B before October 1 of the cap year, you may be eligible for a 60-day cap-gap extension that bridges your authorization through the H-1B start date. Plan your OPT end date carefully relative to the H-1B lottery timeline. Your DSO can confirm whether cap-gap applies to your situation and issue an updated I-20 if needed.
See which Research Director employers are hiring and sponsoring visas right now.
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