Senior Clinical Science Lead — Trial Strategy & Regulatory
Daiichi Sankyo US
Daiichi Sankyo US is seeking an experienced Clinical Scientist to lead development plans and regulatory sections for pivotal studies. Under supervision, you will draft protocols, ICFs, and submissions, coordinating with the CSL/PS/MM/GCL and external partners. The role requires strong study design, data review, biomarker strategy, and cross-functional collaboration with Biostatistics, Data Operations, Translational Medicine, and Clinical Pharmacology. #J-18808-Ljbffr Daiichi Sankyo US
$162.4k - $243.6k
Daiichi Sankyo is seeking a Clinical Scientist to oversee clinical trials and collaborate with cross-... ...protocols, ensuring regulatory compliance, and leading study strategies. The ideal candidate will have... ...Bachelor's Degree in life sciences and relevant clinical experience...SeniorRegulatory$226k - $391k
...Discovery & Pre-Clinical/Clinical... ...insights fuel our science-based advancements... ...POSITION SUMMARY:The Senior Director,... ...and scientific strategies for late phase... ...(CT). The CL leads the team to develop... ...for global regulatory filings. The CL... ...design of clinical trials and for the...SeniorRegulatoryFull timeTemporary workImmediate start- 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...SeniorRegulatory
- Precision Medicine Group is seeking an experienced Senior Principal Biostatistician to provide statistical leadership across all phases of clinical development, including NDA/BLA/MAA submissions and regulatory strategy. You will serve as a subject matter expert in Bayesian...SeniorRegulatory
- ...Myers Squibb is seeking a Senior Manager, Global Clinical Scientist to design and... ...programs. The candidate will lead trial activities, collaborate... ...protocols, and ensure regulatory compliance across trials.... ...Requirements include life sciences advanced degrees, GCP/ICH...Regulatory
- A software development company seeks a Clinical Research Associate in Raritan, NJ. The ideal candidate will have at least 5... ...skills are necessary. The role involves managing clinical trial sites, ensuring regulatory compliance, and working with cross-functional teams. This...SeniorRegulatory
$150.8k - $226.2k
...implementation of the quality strategy closely aligned... ...Ensure adequate regulatory inspection and... .../Audits. Lead in a proactive and... ...). Interact with senior CSPV leadership teams... ...and along the clinical trial process in... ...s Degree in Life Sciences, Pharmacy or Medicines...SeniorRegulatoryLocal areaWorldwide- ...Florham Park, NJ seeks a Product Safety Team lead to direct safety strategy for late-stage oncology programs. You will... ...with medical leads, PK/toxicology, regulatory and clinical development to optimize dose selection, trial safety monitoring and PV document creation...SeniorRegulatory
$215k - $295k
Shionogi Inc. is seeking a Director/Senior Director of COA Strategy in Florham Park, NJ. This role focuses... ...COA strategies for patient-centered clinical trials, providing leadership to cross-functional teams, and ensuring regulatory acceptability of endpoints. The ideal...SeniorRegulatory- Daiichi Sankyo, Inc. seeks a senior clinical development leader to oversee global programs and lead regulatory strategy across multiple Phase II/III studies. You will ensure CRO performance and provide medical input into submissions, translational medicine, and biomarker...Regulatory
$242.7k - $404.5k
...and society.Job SummaryThe Senior Director, Clinical Safety Science is a key leadership role... ...advancing global safety strategy across the product lifecycle... ...science, and ensuring regulatory and compliance excellence... ...management for a group of assets. Lead scientist team to...SeniorRegulatory$191k - $225k
...plus commitment to science and research,... ...enemy: disease. As a Senior Principal Statistician... ...will be part of clinical development teams,... ...clinical trial activities and broader... ...inform development and regulatory decision-making.... ...evidence generation strategies combining clinical...SeniorRegulatoryFull timeTemporary workLocal areaFlexible hours- Novartis seeks a Clinical Study Data Lead based in East Hanover, NJ, with a hybrid work model (12 onsite... ...). You will partner with Clinical Trial Teams to shape end‑to‑end data delivery... ...management activities, define trial data strategies, oversee data collection to lock, and...
- Novartis Group Companies in East Hanover, New Jersey, is seeking a Clinical Study Data Lead to shape data strategy and drive end-to-end data delivery across multiple trials. This hybrid role supports 12 onsite days per month and requires expertise in clinical data management...
- ....Job DescriptionThe Trial Supplies Operations... ...implementation of appropriate Clinical Supplies strategies and processes in... ...supplies meeting regulatory requirements for... ...• Bachelors Degree (Science) required• A degree... ...ManagementExperience level: Mid-Senior LevelIndustry:...RegulatoryWork at officeLocal areaImmediate start
$147.3k - $243k
...support for all phases of clinical development. Specific... ...clients regarding clinical trial study design and regulatory strategy, writing and reviewing statistical... ...statistical results. Lead complex programs such as... ...Minimum Required: Senior Principal Biostatistician...SeniorRegulatoryFlexible hours- Merck & Co. is looking for a Senior Director, Clinical Safety Science, to shape and advance global safety strategy throughout the product lifecycle. This leadership role oversees a team of Safety Scientists, ensuring proactive safety surveillance and risk mitigation. The...Senior
$242.7k - $404.5k
Daiichi Sankyo US is looking for a Senior Director, Clinical Safety Science to lead global safety strategy across the product lifecycle. This key role oversees a team of Safety Scientists and collaborates with various stakeholders for proactive safety surveillance and risk...Senior$175k - $300k
...insights fuel our science-based... ...and cures. We lead where medicine... ...Prostate. The Senior Global Medical... ...optimization for our strategy and launch readiness... ...unmet need and clinical impact expected... ...analysis, and regulatory environment.Knowledge... ..., Clinical Trials Operations,...SeniorRegulatoryFull timeLocal areaImmediate startWorldwide$150.5k - $245.5k
...Senior Manager, Statistical Programming... ..., we use science and innovation... ...studies through regulatory approval, product... ...shape department strategy and mentor talent... ...role: Lead programming support... ...honed in a clinical data environment... ...understanding of clinical trial principles and...SeniorRegulatoryWorldwide$237k - $340k
...plus commitment to science and research,... ...seeking a visionary Senior Director, Global... ...our global medical strategy across one of... ...medical and scientific lead, driving... ...Support and oversee clinical trial activities as well... ...Clinical Development, Regulatory, HEOR, and Market...SeniorRegulatoryFull timeTemporary workWork at officeLocal areaRemote workWorldwideFlexible hours$109k - $174.8k
...Sub Function: Clinical Data ManagementJob... ...talent for our Senior Data... ...insights fuel our science-based advancements... ...systems at the trial and/or program... ...activities, take a lead role, and may coach... ...and/or regulatory environment through... ...clinical development strategies is preferred....SeniorRegulatoryFull timeLocal areaImmediate start- AbbVie seeks a Senior Scientific Director in Oncology Clinical Development (Non-Hodgkin Lymphoma) to lead multiple NHL programs and cross‑functional... ..., data integrity, regulatory coordination, and strategic... ...extensive hematology and NHL trial experience, a strong publication...SeniorRegulatory
$329.03k
...programs, alliances, large trials, such as global clinical development program... ...studies; Reviews regulatory documents from cross... .... Provides senior level clinical representation... ...health authorities; Leads the creation of... ...developmental and regulatory strategy; Accountable for...Regulatory- ...Director/Scientific Director to oversee clinical trials within a development program. You will... ...quality clinical data supporting product strategy. Responsibilities include oversight of... ..., safety and efficacy assessments, regulatory submissions support, and interaction with...Regulatory
- ...Innovative Medicine seeks a Manager, Clinical Data Management to lead data acquisition efforts across... ...sites in the US. The role emphasizes regulatory compliance, risk management, and collaboration... ..., vendor coordination, and data strategy to support clinical development and...SeniorRegulatoryRemote work
$128.6k - $210k
...Manager, Regulatory Affairs Strategy Oncology At Regeneron, we use science and innovation to develop life-changing... ..., preclinical and clinical areas of drug development... ...preparation Leads and tracks queries and... ...CTAs towards clinical trial activations preferred...RegulatoryWorldwide$109k - $174.8k
...merit. Job Function Regulatory Affairs Group Job... ...fuel our science-based advancements... ...best talent for a Senior Regulatory Affairs... ...with the regulatory strategy Work cross-... ...departments, and lead team meetings as... ...strategies Review clinical trial plans, protocols...SeniorRegulatoryTemporary workLocal areaImmediate startFlexible hours- Novocure Inc is seeking a Clinical Trial Lead in a hybrid role (Chesterbrook, PA) to oversee global outsourced studies. You will lead cross... ..., and ensure timelines, budgets, and quality meet regulatory standards. The ideal candidate has 5-7+ years in clinical research...Regulatory
$171.12k - $256.68k
...Study Delivery Lead (SDL) leads the... ...core and extended clinical study team in... ...the clinical trial with consistency... ...is suitable for regulatory submission. The... ...Study Strategy and Study Execution... ...Asset Lead (or Senior Line Leaders in... ...Degree In Life Sciences field and a minimum...RegulatoryContract workLocal area
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