Senior Manager, Clinical Study Lead, Inflammation & Immunology
$150.5k - $245.5kRegeneron Pharmaceuticals, Inc.
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Clinical Study Lead to join our Clinical Trial Management team, accountable for the global execution of large and complex clinical trials from study design through close out. In this role, you will lead cross-functional study teams and oversee CROs and vendors, ensuring studies are delivered on time, on budget, and in accordance with ICH/GCP and Regeneron SOPs. You will also supervise Clinical Trial Management staff and drive process improvement initiatives. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
- Location: Tarrytown, NY, Warren, NJ, Cambridge, MA
- Work model/flexibility: Primarily on-site with hybrid flexibility
- Travel percentage: Up to 25%
Discover your role:
- Lead the cross-functional study team as the primary point of contact for assigned studies, with high independence and accountability for timelines, budget, and quality
- Provide operational input into protocol development and key study documents, including data management, monitoring, and statistical analysis plans
- Lead feasibility assessments, site evaluation and selection, investigator meetings, and patient recruitment and retention strategies
- Select, contract, and oversee CROs and third-party vendors to ensure delivery against the scope of work
- Manage study budgets and timelines, identify risks, and escalate issues with clear mitigation plans
- Oversee data quality, protocol deviations, and study systems such as CTMS and TMF to keep studies audit and inspection ready
- Manage study close-out activities and contribute to clinical study reports and lessons learned
- Supervise, coach, and develop Clinical Trial Management staff while driving innovation and process improvement across the department
This role requires:
- Bachelor’s degree and 8+ years of relevant clinical trial experience
- Extensive experience in global clinical trial operations, with knowledge of ICH/GCP and regulatory guidelines
- Line management experience and the ability to build, lead, and develop productive study teams
- Strong budget management, vendor management, and negotiation skills
- Exceptional interpersonal, communication, and influencing skills across a wide range of stakeholders
- Preferred: Advanced proficiency in trial management systems (CTMS, EDC, IVRS/IWRS) and MS applications
- Preferred: Awareness of relevant industry trends and experience driving process improvement
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$150,500.00 - $245,500.00$150.5k - $245.5k
...Regeneron seeks a Senior Clinical Study Lead to manage global clinical trial execution from design through close-out. The role involves leading cross-functional teams, overseeing vendors and contract research organizations, and ensuring compliance with ICH/GCP guidelines...SeniorContract work$115k - $215k
...are:Kymera is a clinical-stage biotechnology... ...the clinic for immunological diseases, Kymera... ...an industry-leading pipeline of oral... ...highly motivated Manager or Senior Manager, Clinical... ...process for clinical studies across the... ...supporting immunology or inflammation clinical...Senior$137.8k - $206.8k
Job DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols...SeniorFull timeSummer workRemote workFlexible hours2 days per week$215k - $335k
...production.Position Summary:The Clinical Development Lead (Medical Director or Senior Medical Director level)... ...from exploratory studies to FIH trials.Partner... ...with Project Management to develop integrated timelines... ...therapeutic areas (oncology, immunology and/or metabolic...SeniorRemote work- ...seeks an experienced clinical development leader to serve as Senior Director of the... ...Group within Inflammation & Immunology. This strategic role... ..., portfolio management, and driving AI-enabled... ...Lead and mentor clinical... ...dermatology pipeline studies Partner with cross...Senior
- ...Senior Director, Clinical Pharmacology Reporting to the SVP... ...and biodistribution studies, and will be accountable... ...rigor Manage CROs and translational... ...governance meetings Lead or participate in... ...clinical experience in immunology, inflammation, and/or...SeniorWork at office3 days per week
$160k - $170k
...With deep expertise in immunology and inflammation, Kiniksa is advancing a... ...medicines, anchored by its lead product, ARCALYST, the... ...to the Sr. Director, Clinical Supply Chain, the Senior Manager, Clinical Supply Chain... ...across assigned clinical studies and programs. This role...SeniorContract workWork at officeFlexible hours$229.8k - $402.8k
...globe.Your RoleYou will provide senior medical and strategic leadership across global immunology clinical development programs, ensuring... ...expectations. You will lead global clinical development planning... ...clinical results through study reports, regulatory documents,...Flexible hours3 days per week$130k - $170k
...alternative application process. Clinical Trial Manager / Senior Clinical Trial Manager... ...a major shift in how immunology therapies are discovered and... ...a stellar team of leading immunology drug developers... ...execution of early‑phase clinical studies under the direction of the...SeniorFull timeWork at officeLocal areaRemote workShift work$206.25k - $297.92k
Job Title: US Senior Medical Director, NeurologyLocation... ...Medical Next Gen Immunology team, a segment of... ...partner with Clinical, Commercial,... ...Science Liaison Managers, and Medical Science... ..., Be Bold, and Lead Together.Develop strategy... ...IIIB-IV clinical study programs.Support...SeniorFull time$236.25k - $341.25k
Job title: Senior Medical Director, AATDLocation... ...to shape and lead the AATD medical strategy... ...scientific and clinical expertise to... ...product lifecycle management from late-stage development... ...protocols, study designs, and regulatory... ...(Allergy/Immunology, Internal Medicine...SeniorFull time$266k - $344k
...Medicines is a clinical-stage... ...delivering category-leading precision therapies... ...dysregulated immunological and... ...Summary: The Senior Director, Clinical... ...including PK/PD study design and... ...years of vendor management oversight experience... ...immunology, inflammation, autoimmune...SeniorLocal areaFlexible hours2 days per week$315k - $370k
...With deep expertise in immunology and inflammation, Kiniksa is... ...medicines, anchored by its lead product, ARCALYST,... ...most.We are seeking a Clinical Development Lead (... ...interpretation of clinical studies, working cross-... ...of study specific management plans and materials,...Work at office$274.4k - $411.6k
...Massachusetts.Summary The Senior Director, Clinical Development will... ...this individual will lead cross-functional clinical... ...plans, oversee study execution and medical... ...Affairs, Drug Safety, Data Management, Quality, and... ...biology, cancer genetics, immunology, and precision...Senior$279.45k - $302.22k
.... With deep expertise in immunology and inflammation, Kiniksa is advancing a growing... ..., anchored by its lead product, ARCALYST, the first... ...and strategic Senior Director, Clinical Translational Scientist reporting... ...concept and registrational studies. The successful candidate...SeniorWork at office$284.25k
...effect by early 2029.The Senior Medical Director, Oncology Clinical Development - Sarcoma,... ...of clinical studies. This role ensures that... ...the Clinical Development Lead (CDL), the Senior Medical... ...therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and...SeniorFull timeWork at officeLocal areaRelocation2 days per week$293k - $345k
...Senior Medical Director, Medical Affairs... ...is a clinical‑stage biotechnology... ...category-leading precision therapies... ...dysregulated immunological and inflammatory... ...relationship management, and the... ...approaches, registry studies) to support... ...immunology and inflammation — with primary...SeniorLocal areaNight shift2 days per week$139.1k - $231.9k
...the scientific and clinical oversight of clinical... ...programs within the Inflammation & Immunology (I&I) portfolio. As... ...resourcing needs. The Senior Manager partners with other... ...central to ensuring studies are conducted with the... ...components. Leads the clinical data review...SeniorPermanent employmentH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week$284.63k
...DPosition SummaryYou will lead clinical development medical... ...and later phase studies. You will work... ...In the Respiratory, Immunology, and Inflammation Research Unit (RIIRU... ...Clinical Development Senior Medical Director to... ...Inspiring Others and Managing Conflict • Consistently...SeniorFull timeLocal areaRemote workRelocation2 days per week$113.85k - $189.75k
...the business? If so, this Senior R&D Procurement Manager role could be an ideal... ...Procurement Manager in Clinical Services, you will be accountable... ...YOU the opportunity to lead key activities to... ...therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and...SeniorFull timeContract workLocal area$190.8k - $300.3k
...motivated Principal Scientist (Director) to serve as an Immunology Biomarker Lead within Translational Clinical Biomarkers. This role provides strategic and... ...the following:Rheumatology.Gastrointestinal/mucosal inflammation.Dermatology.Proven track record of driving...Full timeFor contractorsLocal areaFlexible hours$148.5k - $214.5k
Job title: Senior Principal Scientist... ...and Inflammation Therapeutic AreaWe... ...within the Type 2 Immunology cluster. This... ...research and clinical development, offering... ...dual mandate. Leading preclinical... ...lifecycle management initiatives for... ...from clinical studies back into research...SeniorFull time$189.75k - $316.25k
...Position Summary The Clinical Operations Asset Lead is the single... ...strategic leadership to Study Delivery Teams,... ...& Stakeholder Management Own the asset‑level... ...maintaining visibility at a senior level. Excellent... ...: respiratory, immunology and inflammation; oncology; HIV;...Local area$210.4k - $331.1k
...Job Description The Senior Director, Clinical Science, Immunology is responsible for providing... ...spanning multiple studies, programs, and assets. Reporting... ...Section Heads, Asset Leads, Program Development Team... ...for direct management and development of multiple...SeniorFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$78.94k - $128.93k
...Senior Clinical Research Program/Project Manager This position will have dual reporting to the AMC Division of Allergy and Clinical Immunology (ACI) Division Director and the Manager of Finance & Research... ...manager also helps define study responsibilities and level of...SeniorWork at officeLocal areaRemote workShift work$236.25k - $393.75k
...Job Title: Senior Clinical Research Director Location: Cambridge,... ...to resolve project-related study issues Anticipate potential... ...development and life cycle management gained through approximately... ...hematology, transplant, or immunology At least 4 years in the pharmaceutical...SeniorFull time$233.59k - $350.38k
As GCPL in Immunology, you will provide medical and scientific... ...of cell therapy for clinical stage assets and... ...development plans and clinical study design, writing study... ...III, IV or Life Cycle Management studies Delivering... ...and/or sub-teams Lead governance interactions...Full timeTemporary workLocal area- ...Kymera Therapeutics seeks a Senior Manager or Associate Director to lead analytical and technical efforts in clinical trial feasibility and enrollment planning. This role will... ...methodologies and insights to support evidence-based study planning across the clinical pipeline using...Senior
$150.5k - $245.5k
...Regeneron seeks a Senior Manager to lead clinical study strategy for immune and inflammatory disease programs. The role involves designing and executing clinical trials, partnering with cross-functional teams, and advancing therapeutic candidates through early and late...Senior- ...therapeutic areas including immunology, oncology and... ...the practical and clinically relevant... ...stage development. Leads gap assessments, develops... ...Position title of Senior Scientific... ...# Initiate and manage medical affairs activities... ...independently lead clinical studies or medical affairs...SeniorLocal area3 days per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Manager, Clinical Study Lead, Inflammation & Immunology. Be the first to apply!
- behavioral health supervisor Cambridge, MA
- lead clinical data manager Cambridge, MA
- associate medical director Cambridge, MA
- occupational health manager Cambridge, MA
- director behavioral health Cambridge, MA
- junior clinical data manager Cambridge, MA
- clinical manager Cambridge, MA
- remote medical billing manager Cambridge, MA
- clinical operations supervisor Cambridge, MA
- associate director clinical data management Cambridge, MA




