- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross functionally with multiple functions and groups throughout the US organization, Clinical Development , Research & Early Development , other affiliates, ... Prioritizes phasing of objectives based on engagement objectives and sales forecasts. Lead the development and execution of annual and long-term brand… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …talent and benefit from a range of possibilities for professional and personal development . Are you ready to realize your potential? The Position The purpose of ... supporting various company initiatives and functions such as Marketing, IT, Clinical , Research, Operations, Patient Support Programs, and Digital Health Lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...to FDA and Health Canada. This individual also supports senior staff with required systems and process maintenance. Responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management ... a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead ).-Where ... with different levels of study governance, as required-Oversee the development of the clinical study plan including...The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reports are properly trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of ... a coordinated and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director, Global Clinical Operations on plans for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US and Global Brand Team, and US Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic ... Cycle Management. Leads the team for this compound.Responsibilities- Responsible for the development of the USOMA strategy and medical objectives for the assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical ... affairs projects within a specific compound or indication.Responsibilities- Support GMA the development of the Global Medical Affairs strategy and execution of the… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset, NJ. Role ... OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and...strategy from early research through IND-enabling studies and into clinical development , ensuring regulatory compliance and scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …objectives are aligned and embedded in evidence generation, medical strategy, and clinical development plans, where appropriate. Gains strategic and planning ... strategy across medical, RD, and enterprise partners to advance oncology objectives.- Lead the development of a global External Scientific Collaboration (ESC)… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Development Lead sits within Clinical Development ... dedicated to the effective design and execution of drug development . Clinical Development drives ... clinical trials (eg significant experience as a senior clinical leader), and exhibits all of… more
- Regeneron Pharmaceuticals (Warren, NJ)
- The ** Senior Clinical Study Lead **...the assigned study + Provides operational input into protocol development + Oversees and provides input to the ... for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study...study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …**Job Description** **Position Summary** Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience ... Senior Director, GCD is responsible for all the clinical development activities for the projects assigned...NDA, BLA, and/or Global filings. **Key Job Responsibilities** + Lead the clinical development strategy… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- ** Senior Director, Early Development Team Lead ** **Role Summary:** The Early Development Team (EDT) Lead is a critical role - working to deliver ... development , including, CMC (small molecules and biologics), biology, toxicology, clinical pharmacology, ADME/DMPK, early clinical development , etc. -… more
- Parexel (Trenton, NJ)
- …a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead , Master/ Senior Medical Review Officer who is looking to draw upon ... with expert level industry or regulatory knowledge experience in Clinical Development / Clinical Trial Design, ...agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead… more
- Bristol Myers Squibb (Princeton, NJ)
- …training Clinical Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops clinical plans and ... Senior Clinical Trial Physician sits within Clinical Development , which is a global organization...is required + Ability to communicate information clearly and lead presentations in scientific and clinical settings… more
- Bristol Myers Squibb (Princeton, NJ)
- …team members + May support clinical development planning (collaboration with Clinical Development Lead / Clinical Trial Physician for provision and ... activities as applicable + Evaluate innovative trial designs (collaboration with Medical Monitor/ Clinical Development Lead ) + Protocol and ICF … more
- Sumitomo Pharma (Trenton, NJ)
- …our R&D Organization. This individual will contribute to the design and execution of clinical development plan(s) for assigned asset(s) and serve as the ... highly motivated, and experienced individual for the position of Senior Medical Director, Clinical Research (Ophthalmology) to... clinical trials in both early- and late-stage clinical development , especially protocol development … more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …methods of procurement, utilizing extensive and deep contracting or technical expertise (eg clinical development operations) + Lead the preparation and ... **Job Description** The Senior Manager, R&D Strategic Sourcing Clinical ...business unit stakeholders as applicable. **Job Description** **Oversee & lead end-to-end development and implementation of Sourcing… more
- Bristol Myers Squibb (Princeton, NJ)
- …rheumatoid arthritis with CAR-T cell therapy. The incumbent will be accountable, alongside the Clinical Development Program Lead , for the development of ... trials enabling market applications. The CTP will report directly to the Clinical Development Program Lead . **Key Responsibilities** * Serves as a primary… more
