Senior Scientist: Regulatory & Clinical Operations
Hims, Inc.
Hims & Hers seeks a Senior Scientist, Regulatory & Clinical Operations to join our Central New Jersey lab. This individual will coordinate FDA-regulated studies with CROs, own study execution from kickoff to completion, and ensure regulatory rigor informs practical decisions in a fast-moving, on-site lab setting. The role combines bench assay execution with regulatory strategy, including IRB and CAPA activities, while maintaining compliance and timelines across study milestones. #J-18808-Ljbffr Hims, Inc.
- Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to lead coordination of FDA-regulated studies in our Central New Jersey on-site lab. The role sits at the intersection of bench science and clinical study execution, reporting to the Director of...OperationsSeniorRegulatory
- ...talent-first flexible/remote work approach, see below and visit . About the Role: Hims & Hers is seeking a Senior Scientist, Regulatory & Clinical Operations to join our growing laboratory organization. This individual contributor will report to the Director of R&D and...OperationsSeniorRegulatoryFull timeInterim roleLocal areaRemote workFlexible hours
$117k - $184.2k
Job DescriptionThe Early Clinical Scientist (ECS) coordinates the design, planning and execution... ...knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.... ...applicable standards. Develops study operational documents with input from team members...OperationsSeniorRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$117k - $184.2k
Job DescriptionThe Senior Clinical Scientist provides scientific leadership for one or more clinical trials or... ...Clinical Directors, Study Managers, Clinical Operations, Medical Monitoring, Data Management, Statistics, and Regulatory colleagues to ensure the scientific...OperationsSeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours$173.39k - $210.11k
...and execution of assigned clinical trial activities and... ...and clinical portions of regulatory documents (e.g., IB, DSUR... ...design, statistics, clinical operations Ability to understand... ...regulations. R1603367 : Senior Manager, Global Clinical Scientist - Psychiatry #J-18808-...OperationsSeniorRegulatoryHourly payFull timeTemporary workPart timeSummer workFlexible hoursShift work$173.39k - $210.11k
## Senior Manager, Global Clinical Scientist - PsychiatryMadison - Giralda - NJ - USFind out how well you match... ...(CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan... ...design, statistics, clinical operations* Ability to understand assigned protocol...OperationsSeniorRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$115k - $125k
...GMP manufacture of Phase I clinical supplies. Authors technical... ...studies and in support of regulatory activities. Provides technical... .... Mentors junior scientists in formulation techniques, experimental... ...to support laboratory operations. Qualifications: MS...OperationsSeniorRegulatoryWork at officeLocal area- ...About The Role Hims & Hers is seeking a Senior Scientist, R&D to join our growing laboratory... ...support assay implementation into clinical operations. The ideal candidate is bench‑strong,... ...reports in compliance with quality and regulatory standards Laboratory Execution Perform...OperationsSeniorRegulatoryFull timeLocal areaRemote workFlexible hours
$282.2k
Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for... ...planning and directing clinical research activities... ..., monitoring, analysis, regulatory filing, and publication.... ...clinical trials (design, operational plans, settings) based on...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours$333.3k
...Our Future Together:The Senior Medical Director, Clinical Development provides clinical... ...; clinical components of regulatory documents/registration... ...conferencesDiscover Your Role:Manages all operational aspects and drives... ..., assigned Clinical Scientist and Clinical Operations...OperationsSeniorRegulatoryWorldwide$210.4k - $331.1k
...Medicine (TMed) drives early clinical development of novel therapeutics... ...patients. Our Clinical and Operations organization designs and... ...clinical supplies, data management, regulatory, etc.) across departments,... ..., and influence peers, senior leaders, and external partners...OperationsSeniorRegulatoryFor contractorsWorldwideRelocationVisa sponsorshipFlexible hours- ...Senior CRA - Northeast RegionICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new... ...conducted according to protocol, regulatory requirements, and industry... ...to facilitate smooth trial operations.Your Profile:Advanced...OperationsSeniorRegulatory
- ...seeks a Statistics & Decision Sciences Principal Scientist, Biostatistics, to lead complex statistical analyses across clinical programs. The role requires expertise in... ...partners. The position emphasizes leadership, regulatory awareness, and advancement of statistical methodologies...SeniorRegulatory
$237.4k - $298.9k
...Senior Director, Clinical PharmacologyPTC Therapeutics is a global commercial biopharmaceutical company... ..., biostatistics, medical writing, regulatory, commercial, toxicology, preclinical... ...regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate....OperationsSeniorRegulatoryContract workTemporary workWork at office$242.7k - $404.5k
...and society.Job SummaryThe Senior Director, Clinical Safety Science is a key leadership... ...oversees a team of Safety Scientists who partner with Safety... ...safety science, and ensuring regulatory and compliance excellence. In addition to operational oversight, this role contributes...SeniorRegulatory$173.2k - $272.6k
Job DescriptionThe Clinical Imaging Scientist (Principal Scientist) leads complex... ..., technical, and operational imaging expertise to ensure... ...Clinical Imaging, Imaging Leads, Senior Clinical Imaging... ...service providersProvide regulatory-facing imaging expertise to...OperationsRegulatoryFull timeFor contractorsLocal areaRemote workFlexible hours$145.47k - $176.27k
...Our Analytical Science and Operations team creates... ...administered to patients in clinical studies. Our team is involved... ...launch. Position Summary The Senior Principal Scientist will serve as a CMC Analytical... ...ICH guidelines and global regulatory requirements and has significant...OperationsSeniorRegulatoryHourly payFull timeTemporary workPart timeSummer workLive inRemote workFlexible hoursShift work$136.6k - $171.9k
...and culture! Site: Job Description Summary: The Senior Manager, Clinical Operations is responsible for the operational planning, execution,... ...trials are conducted in compliance with applicable regulatory requirements, ICH-GCP guidelines, company Standard Operating...OperationsSeniorRegulatoryFull timeContract workTemporary workWork experience placementWork at office- Daiichi Sankyo US is seeking an experienced Clinical Scientist to lead development plans and regulatory sections for pivotal studies. Under supervision, you will... ...collaboration with Biostatistics, Data Operations, Translational Medicine, and Clinical Pharmacology...OperationsSeniorRegulatory
- Precision Medicine Group is seeking a clinical trial lead to oversee the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, ICH-GCP, and regulatory requirements. You will manage feasibility, site start-up, enrollment, and quality deliverables...OperationsSeniorRegulatory
- ...Description CORE JOB RESPONSIBILITIES: Assist the Clinical Research team to interface with project team... ...including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. Review and query of hematology...OperationsRegulatoryPermanent employmentContract workWork at officeImmediate start
$122k - $212k
....Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function... ...more at The Clinical Project Scientist is responsible for the design,... ..., requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies;Reviews...OperationsRegulatoryFull timeTemporary workLocal area$107.5k - $173.08k
...seeking a highly skilled and motivated Senior Scientist with a strong background in mRNA... ...development initiatives and manufacturing operations for excipients and reagents.What We’re... ...tools.Exposure to GMP/GLP environments, regulatory documentation, method qualification,...OperationsSeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours- ...experienced leader in Translational Medicine. You will co-own the early clinical development strategy for immunology therapeutics, overseeing... ...holds a degree in Life Sciences, has extensive clinical operations experience, and possesses strong leadership and decision-...OperationsSeniorFlexible hours
$170k - $190k
The Senior Clinical Trial Drug Supply Manager is a critical position within the clinical development... ...the execution of clinical trials and regulatory submissions. This role will be... ...oversight of drug supply forecasting, operational planning and execution, supply coordination...OperationsSeniorRegulatoryTemporary workWork at officeFlexible hours- A leading IT staffing firm seeks a Technical Operations Contractor responsible for managing the technical aspects of lifecycle management... ...process improvements while ensuring compliance with regulatory requirements. Strong analytical skills and the ability to work...OperationsSeniorRegulatoryFor contractors
$285k - $315k
...Job Title Senior Director, Clinical Development Requisition JR000015848 Senior Director, Clinical... ...and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, regulatory authorities, medical affairs, Key...OperationsSeniorRegulatoryWork at officeFlexible hours- ...CROs across the research and clinical trials landscape. By... ...we deliver consulting (both operational and strategic) and Functional... ...a talented and enthusiastic Senior Clinical Research Coordinator... ...applications and preparation of regulatory documents, study documents and...OperationsSeniorRegulatoryFull timeTemporary workWork at officeRemote work
$226k - $391k
...Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub... ...at POSITION SUMMARY:The Senior Director, Clinical Leader (CL... ...phase compounds (Ph2b/3), and operational implementation, delivered through... ...documents for global regulatory filings. The CL will manage...OperationsSeniorRegulatoryFull timeTemporary workImmediate start$105.4k - $148.8k
Kenvueは現在、a: Senior Scientist- Self Care 私たちがしていること Kenvueで、 日常のケアの並外れた力を実感します。100年以上にわたる伝統... ...development process. Stay current with regulatory guidelines and industry standards to... ...required. Experience in typical unit operations such as granulation, roller compaction...OperationsSeniorRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Scientist: Regulatory & Clinical Operations. Be the first to apply!
- senior manager automotive Plainfield, NJ
- senior application administrator Plainfield, NJ
- srs Plainfield, NJ
- senior manager m&a tax Plainfield, NJ
- senior manager diversity & inclusion Plainfield, NJ
- senior Plainfield, NJ
- senior accountant remote Plainfield, NJ
- senior implementation project manager Plainfield, NJ
- senior operations technician Plainfield, NJ
- senior manager tax Plainfield, NJ


