Senior Clinical Regulatory Strategist — Hybrid
Iterative Scopes
Iterative Health is seeking a Senior Clinical Regulatory Specialist to support compliant execution of Phase 2–4 industry-sponsored trials across our network. You will provide regulatory guidance and oversight from startup through closeout, partnering with sites, sponsors, CROs, IRBs, and internal teams to ensure timely, compliant submissions. The role emphasizes independent management of multiple studies, strong knowledge of GCP and FDA regulations, and driving process improvements for ongoing #J-18808-Ljbffr Iterative Scopes
- Takeda in Cambridge, MA seeks a Senior Manager, Clinical Trial Delivery and Pharmacovigilance Documentation Excellence in a hybrid role. You will lead TMF/eTMF and PV documentation... ...global teams. The role requires deep regulatory knowledge, strong governance and vendor...SeniorRegulatory
- Climb Bio, Inc. is seeking a Senior Clinical Trial Manager to lead end-to-end delivery of Phase... ...management, strong knowledge of GCP and regulatory requirements, and excellent communication. This position offers a remote or hybrid model based out of Wellesley, MA, with travel...SeniorRegulatoryRemote job
- Pfizer in Cambridge, MA seeks a Senior Manager to provide scientific and clinical oversight of clinical trials in the Inflammation & Immunology portfolio.... ...collaboration across Clinical Operations, Biostatistics, Regulatory Affairs, and Clinical Pharmacology. The incumbent...SeniorRegulatory
- Scorpion Therapeutics in Cambridge, MA is seeking a Senior Manager, Clinical Development Scientist to oversee clinical trial conduct and data... ...data reviews, manage external committees, collaborate on regulatory documents, and mentor team members. #J-18808-Ljbffr PfizerSeniorRegulatory
$210.4k - $331.1k
...Merck seeks a Senior Director of Clinical Science for Breast Oncology to lead strategic clinical science... ...multiple studies and programs. This hybrid role combines deep therapeutic... ...Strong collaboration skills across regulatory, biostatistics, safety, and medical affairs...SeniorRegulatory$210.4k - $331.1k
Job DescriptionRole Summary:The Senior Director, Clinical Science, Breast Oncology is responsible for providing strategic Clinical Science leadership... ...requires close collaboration with Clinical Operations, Regulatory Affairs, Biostatistics and Data Management, Drug Safety...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours- Iterative Health in Cambridge, MA, is seeking a Senior Clinical Regulatory Specialist to oversee regulatory activities for Phase 2-4 trials across... ..., and experience with CTMS and regulatory submissions. Hybrid work model with on-site collaboration. #J-18808-Ljbffr Iterative...SeniorRegulatory
- ...Staffing Group in Massachusetts seeks a Senior Planner, Materials Management to join a... ...internal and external sites in a hybrid schedule with two onsite days per week,... ..., Manufacturing, Quality, Development, Regulatory, Clinical, and Commercial teams to translate demand...SeniorRegulatory2 days per week
- ...company powering the acceleration of clinical research to transform patient outcomes... ...with 250+ employees world-wide.As a Senior Clinical Regulatory Specialist at Iterative Health, you will... ...— professionally and personally.Hybrid work environment with in-office collaboration...SeniorRegulatoryTemporary workWork at office2 days per week
$137.8k - $206.8k
Job DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study-level... ...environment. This position is on-site or hybrid and is not eligible for a fully... ...compliance across clinical programs.Support regulatory agency inspections at Vertex and/or...SeniorRegulatoryFull timeSummer workRemote workFlexible hours2 days per week- Role Senior Manager, Clinical Development Scientist, overseeing clinical trial conduct and data integrity... ...external committees, collaborate on regulatory documents, and mentor team members.... ...travel may be required. Work Setup hybrid onsite role requiring 2.5 days/week...SeniorRegulatoryRelocation package2 days per week
$210.4k - $331.1k
...Description Job Summary The Senior Director of Clinical Science provides strategic clinical/scientific... ...and clinical guidance for key regulatory documents, Health Authority... ...10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving...SeniorRegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$210.4k - $331.1k
...Merck seeks a Senior Director of Clinical Science to provide strategic leadership for early-phase oncology assets from candidate transition through... ...and safety data for strategic decisions Knowledge of regulatory expectations and emerging oncology development...SeniorRegulatory$210.4k - $331.1k
...Merck seeks a Senior Director of Clinical Science for Gynecologic Oncology to lead strategic clinical science oversight across multiple development... ...Strong cross-functional collaboration skills with regulatory, biostatistics, and clinical operations Demonstrated ability...SeniorRegulatory$210.4k - $331.1k
...Senior Director role providing strategic clinical science leadership across infectious disease studies, programs, and assets at Merck. Responsible for disease... ...Strong cross-functional collaboration skills with regulatory, biostatistics, and medical affairs Track record...SeniorRegulatory$210.4k - $331.1k
...Senior Director of Clinical Science overseeing thoracic oncology programs at Merck. Provides strategic leadership across multiple studies and... ...organizations Strong cross-functional collaboration skills with regulatory, biostatistics, and medical affairs Track record of...SeniorRegulatory$210.4k - $331.1k
...Senior Director role providing strategic clinical science leadership across pulmonary hypertension and cardiovascular programs at Merck. Responsible for... ...Strong cross-functional collaboration skills with regulatory, biostatistics, and medical affairs functions Knowledge...SeniorRegulatory$119.7k - $222.3k
...Level 4 Job Description Summary Hybrid Location: Cambridge (USA) We... ...strategies to transform clinical pharmacology support of transformative... ...and interactions with regulatory agencies, as appropriate Proactively... ...to be considered for Senior Principal Scientist. Extensive...SeniorRegulatory$280.6k - $420.8k
Job DescriptionGeneral Summary:The Senior Medical Director will define the clinical development strategy of... ...strategyParticipates in the preparation of regulatory documents in support of... ...and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...SeniorRegulatoryFull timeSummer workRemote workFlexible hours2 days per week$280.6k - $420.8k
Job DescriptionGeneral Summary:The Senior Medical Director will define the clinical development strategy of an asset,... ...in the preparation of regulatory documents in support of regulatory... ...and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...SeniorRegulatoryFull timeSummer workRemote workFlexible hours2 days per week$236.25k - $393.75k
Job Title: Senior Clinical Research DirectorLocation: Cambridge, MA About the JobJoin the engine... ...Project Head, PV Representatives, Regulatory, and other key functional representativesClinical... ...protected by law. #GD-SA #LI-SA #LI-Hybrid#vhd Pursue progress, discover...SeniorRegulatoryFull time$257.6k - $404.8k
...your future at Takeda. Join us as a Senior Medical Director, Clinical Science Neuroscience, in our Cambridge... ...the medical, scientific, regulatory and commercial issues for assigned Takeda... ...position is currently classified as “hybrid” in accordance with Takeda’s Hybrid...SeniorRegulatoryMinimum wageWork at officeLocal areaRemote workNight shift$210.4k - $331.1k
...Merck seeks a Senior Director of Clinical Science for Gastrointestinal Oncology to provide strategic leadership across multiple clinical programs... ...in clinical endpoints, data interpretation, and regulatory considerations Experience managing and developing scientific...SeniorRegulatory$137.2k - $205.8k
...Summary:The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of... ...program-level activities.This is a hybrid role which allows for 2 days per week...SeniorRegulatoryFull timeSummer workWork at officeRemote workFlexible hours2 days per week3 days per week$140k - $165k
...powering the acceleration of clinical research to transform patient... ...employees world-wide.As the Senior Manager, Clinical Operations-... ...study startup, feasibility, regulatory processes, protocol execution... ...professionally and personally.Hybrid work environment with in-office...SeniorRegulatoryTemporary workWork at office2 days per week$210.4k - $331.1k
...Senior Director position leading clinical science strategy across a vaccine portfolio at a major pharmaceutical company. The role involves strategic... ...Strong knowledge of clinical endpoints, study design, and regulatory considerations Demonstrated success managing and...SeniorRegulatory$305.7k - $413.7k
...is an opportunity to provide clinical leadership in developing RNAi... ...clinical development programs.The Senior Director, Clinical Research,... ...a matrix organization across Regulatory, Biostatistics, Clinical... ...scientific meetings.This position is hybrid and will be primarily located...SeniorRegulatoryFull timeTemporary workLocal areaFlexible hours- ...Brigham NCRI) in Somerville, MA is seeking a Clinical Trial Assistant Project Manager (Systems use)... ...train staff, manage data and budgets, and ensure regulatory compliance across the Research Portfolio. This role can be hybrid or remote, with on-site duties at 399...RegulatoryRemote job
$210.4k - $331.1k
...Merck seeks a Senior Director of Clinical Science to provide strategic leadership across lung and head & neck clinical development programs.... ...strategy, overseeing clinical evidence interpretation, guiding regulatory interactions, and building scientific capabilities across...SeniorRegulatory- Massachusetts Institute of Technology is seeking a Senior Licensing and Business Development Officer within the Technology Licensing Office... ..., and craft term sheets and IP distribution mechanisms. This hybrid role involves collaboration across disciplines and external...SeniorWork at office
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