- Merck & Co. (Rahway, NJ)
- …support and influence clinical and commercial combination product development and launches.Principal Responsibilities: Lead and set direction for the ... with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… 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
- Merck & Co. (Rahway, NJ)
- …assurance, analytical laboratories, manufacturing, production support area, clinical development .-Strong leadership skills with the ability to lead teams ... shift.-Required Skills: Accountability, Accountability, Adaptability, Audits Compliance, Biochemistry, Chemistry, Clinical Development , Communication, Data Analysis, Detail-Oriented, Deviation… more
- Merck & Co. (Rahway, NJ)
- …and provides biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, ... disease area. Primary activities :Serves as statistical representative and lead in the cross-functional teams for the strategic planning... project as neededLead biostatistics in early or late clinical development planning to ensure that study… more
- Merck & Co. (Rahway, NJ)
- …clinical drug development , GCP and ICH guidelines, and the clinical regulatory environmentDemonstrated ability to influence senior level stakeholders and ... clinical organization within Translational Medicine (TMed) is responsible for early clinical development of novel therapeutics, working in close collaboration… more
- Eisai, Inc (Nutley, NJ)
- …3 years MSL experience in Oncology/Hematology.Strong broad-based scientific and pharmaceutical knowledge. Clinical trial development and drug launch experience is ... and oncology, with a strong emphasis on research and development . Our history includes the development of...and its hhc mission; b) provide key scientific and clinical information about Eisai's products; provide a conduit for… more
- Merck & Co. (Rahway, NJ)
- …organizations (as a lead GCS Planning program representative) such as clinical development , regulatory, quality and other supply chain areas to negotiate ... external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs… more
- Insmed Incorporated (NJ)
- …stakeholders across the company including market access, marketing, medical affairs, and clinical development to understand and support Insmed's business needs. ... This is a global role.What You'll Do: Lead development of HEOR strategy for gene...of HEOR strategy for gene therapy products from early clinical development through product launch and life… more
- Merck & Co. (Rahway, NJ)
- …and OT/IT systems that enable formulation, filling, and support activities for clinical and development sterile products. This position supports start-up ... Job DescriptionThe Senior Automation Specialist provides end-to-end automation and quality...& Experimentation) center, with a primary focus on sterile clinical manufacturing within Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations… more
- Merck & Co. (Rahway, NJ)
- …our Company communications teams. Key Responsibilities Product Strategy & Roadmap Lead and manage IT applications supporting corporate communications, serving as the ... priorities as new insights and data emerge. Discovery & User Research Lead ongoing discovery activities (user research, interviews, surveys, usability testing) in… more
- Insmed Incorporated (NJ)
- …specialists, and community physicians.Partner with Medical Affairs to ensure scientific and clinical insights inform HCP strategies. Lead development and ... including positioning, messaging, and go-to-market frameworks tailored to HCPs treating fibrosing ILDs. Lead campaign development to engage pulmonologists, ILD… more
- Genmab (NJ)
- …Senior Manager, Biostatistics acts as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until proof of ... concept, and/or as trial responsible statistician.ResponsibilitiesCompound/Indication LevelAct as lead and main point of contact related to Statistics for designated… 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
- Insmed Incorporated (NJ)
- …CTAs) by demonstrating leadership competencies.Works collaboratively with Clinical Scientist, Clinical Indication/ Development Lead , and clinical ... CROs and other specialty vendors is essential.Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements… more
- Insmed Incorporated (NJ)
- …to ensure key clinical and research insights inform HCP strategies. Lead development and implementation of tactical planning, sequencing and KPIs, ... other, and for the future of science, we're in. Are you?About the Role:The Senior Director, Head of US HCP Marketing for our brensocatib program in HS (hidradenitis… more
- Genmab (NJ)
- …and operational risk analysis.Serve as a senior strategic partner to Development Operations (DevOps), Clinical Strategy and external partners to inform study ... leadership of complex, global feasibility initiatives and ability to influence clinical development strategy.Track record of cross-functional leadership in… 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
- 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
- Insmed Incorporated (NJ)
- …functional collaboration will be vital as you partner with Discovery, Clinical Development , Quality, Regulatory Affairs, Operations, and Commercial teams ... activities for the company's small molecule pipeline. As a senior leader, you will oversee drug substance and drug...leadership team and contribute significantly to our overall product development strategy.You'll lead both drug substance (API)… more
