- Fortrea (Boston, MA)
- …leading global contract research organization. We provide comprehensive Phase I through IV clinical trial management , clinical pharmacology, patient ... today's healthcare challenges into tomorrow's solutions.Our OpportunityCome join Fortrea's industry-leading Clinical commercial team! We are hiring a Senior … more
- Adaptive Biotechnologies Corp. (Washington, DC)
- …with key opinion leaders and affiliated institutions required.Demonstrated understanding of clinical trial management .Working knowledge of regulatory ... Senior Medical Science Liaison (West Region) at Adaptive...Science Liaison is responsible for developing and expanding the clinical community's knowledge of the role for Minimal Residual… more
- Rakuten Medical Inc. - US (San Diego, CA)
- …planning and executing of GCP Quality activities to support companywide and clinical development/ clinical trial Quality activities. Successfully lead global ... closely with clinical pharmacovigilance team on supporting clinical trial safety. Present and update CGP...and update CGP quality review metrics and reporting to Sr . Management . Other duties as assigned. Desired… more
- BridgeBio Pharma (San Francisco, CA)
- …drafting, reviewing, and negotiating of a wide range of contracts, including clinical trial agreements, licensing agreements, partnership agreements, and vendor ... and regulatory reporting obligations, such as Form 10-K and Form 10-Q.Advise senior management on the legal requirements and implications of securities… more
- OM1 (Boston, MA)
- …regarding client management issues; implement plan following approval by senior management .Oversee the creation and delivery of client-facing materials, ... and implement best practices to enhance the efficiency and effectiveness of clinical trial operations.Support the development and maintenance of Client… more
- Xenon Pharmaceuticals Inc. (Boston, MA)
- …in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial . In addition, we are proud of the leading-edge science coming ... Planning will be responsible for supply chain planning for clinical supplies ( clinical trial material)...small molecule drug development programs in support of Xenon's clinical trials. The Senior Manager, Supply Chain… more
- Parexel International Corporation (Billerica, MA)
- …Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized ... 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/ Clinical Trial Design, Clinical Strategy, and… more
- Optimapharm (Boston, MA)
- …and CRO environments)Excellent knowledge of GCP and ICH Guidelines required for clinical trial conduct, CTR and CTIS, ISO 14155, MEDDEV/MDCG guidelines ... Your responsibilitiesWork closely with the COO and the Company's Senior Management Team to ensure the Company's...between North American Operations and Head of Departments (PM, Clinical Operations, Regulatory and Start-up, Trial Support,… more
- Travere Therapeutics (Boston, MA)
- …approval strategies using novel endpoints, biomarkers or alternative clinical trial data and critical issue management based on current registration ... outside regulatory agencies and trade associations and act as an advisor/liaison to senior management in order to plan, evaluate and recommend global regulatory… more
- Veeva Systems (Boston, MA)
- …analysis, query resolution, datasets, statistical reporting).Life sciences industry and clinical trial processes (pharmaceutical, biotech, medical device ... making a positive impact on its customers, employees, and communities.The RoleVeeva Vault Clinical Data Management System (CDMS) is changing the way clinical… more
- Abdera Therapeutics (San Francisco, CA)
- …and guidance and manage day-to-day regulatory activities.Provide guidance and expertise to senior management and other departments on all regulatory issues for ... understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology.Strong written, verbal,… more
- Eisai (Washington, DC)
- …broad-based scientific and pharmaceutical knowledge.Excellent presentation and teaching skills. Clinical trial development experience is preferred.Knowledge of ... Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products; provide a conduit for communication between Eisai… more
- Neogene Therapeutics (Santa Monica, CA)
- …address potential disruptions in the supply chain.Ensure the efficient delivery of clinical trial materials, addressing any supply chain challenges that ... breakthroughs.Position SummaryWe are looking for an experienced and strategic Senior Director of Clinical Site Supply Chain...MBA, or PhD).15+ years of experience in supply chain management , with a focus on clinical operations… more
- Medtronic plc (CT)
- …EKG, blood pressure, wave forms, and ancillary procedural solutions.Knowledge of Clinical trial protocols, and CoreValve and other Medtronic TAVR ... Senior Principal Therapy Consultant, CoreValveAt Medtronic you can...and growth. The CoreValve Therapy Consultant practices good territory management with strong organization, administration and expense planning and… more
- Dennis Partners (Boston, MA)
- …documents to support regulatory submissions.Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and ... This clinical -stage company is advancing innovative therapies for people...risks, mitigations, and overall plans to Project Teams and senior management .Contribute to improvements in department best… more
- Genmab A/S (Princeton, NJ)
- …related to the hosting of this site please contact us at ###@Genmab.com. Senior Director, US Medical Affairs Solid Tumor PortfolioApply locations Princeton, NJ time ... RoleAs part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director, USMA Solid Tumor Portfolio. This role will report to the VP/Head of… more
- Discovery Life Sciences (Boston, MA)
- …to 50%Pitch and present Discovery Life Sciences research, translational research, and clinical trial services and cross business unit (sequencing, cell services, ... Position Summary:DLS is looking for a talented and passionate Senior Director, Business Development to join our dynamic sales team. As a Senior Director,… more
- Orca Bio (Menlo Park, CA)
- …successful candidate must have strong regulatory knowledge of drug development, including clinical trial requirements, trial design and data analysis, ... and maintain regulatory affairs systems, ensuring accurate record-keeping and data management .Work closely with Clinical , CMC, Quality, and Commercial teams… more
- Avidity Biosciences (San Diego, CA)
- …relating to clinical trials and other operational aspects of clinical trial preparationDetermine and communicate documentation requirements for submissions ... submissionsPrepare/author documents in collaboration with CRO/regulatory vendors for submission of clinical trial applications in US, and ex-US countriesReview… more
- MannKind Corporation (Boston, MA)
- …Develop and plan innovative regulatory strategies for label enhancements and life cycle product management Counsel and advise senior management / CMO on ... and development processes Experience preparing and overseeing regulatory submissions, including INDs/ Clinical Trial Experience with clinical trials and… more
