- Insmed Incorporated (NJ)
- …CMOs, CROs, 3PLs, IXRS/IRT vendors and other third-party providers in alignment with clinical development and Clinical Operations timelinesFoster and manage ... future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is...contingency strategies, and risk mitigation across global marketsSupport the development and monitoring of clinical supply budgets… more
- Merck & Co. (Rahway, NJ)
- …to: - Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development , regulatory, quality and ... the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program ...and program cost estimates requested by Product Development Teams. Responsible for authoring clinical supply… more
- Insmed Incorporated (NJ)
- …an 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of ... Clinical Operations group including recruitment, training, mentoring, career development , work assignments, performance evaluations and ongoing feedback to and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director , Clinical Operations (Asset Lead) is fully informed of the overall ... and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director , Global Clinical Operations on plans for successful… 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...The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations. In their… more
- Eisai, Inc (Nutley, NJ)
- … Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to ... and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads… more
- Merck & Co. (Rahway, NJ)
- …late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics ... is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent… more
- Insmed Incorporated (NJ)
- …Lead development and execution of global regulatory strategies for clinical , pre- clinical , and lifecycle management activities for assigned programsIdentify ... global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory input to… more
- Eisai, Inc (Nutley, NJ)
- …members.Requirements Bachelor's or Master's degree with 15 or more years significant clinical pharmaceutical experience (ie, clinical development or ... and assess long-term resource, technology, and skill needs for respective program (s) within clinical quality area.Anticipate immediate and long-term risks… more
- Insmed Incorporated (NJ)
- …and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as ... You'll Do: Participate in cross functional teams to develop and implement Clinical Study protocols within clinical program (s). Responsibilities include… more
- Novo Nordisk Inc. (Boulder, CO)
- …Control, Chemical Development , Program Management, Regulatory, Analytical Development , Materials Management, and Clinical Supply Write, review, and/or ... the full R&D continuum, from early research through late-stage clinical development . Here, we are building for...develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all… more
- Insmed Incorporated (NJ)
- …compound(s) Provides program -level programming leadership and support to clinical development teams Provides hands-on programming support to exploratory ... clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory, and Clinical Development , as well… more
- Insmed Incorporated (NJ)
- …Medical Leadership, Medical Directors, Scientific Communications, Field Medical Excellence, Clinical Development , and Commercial Effectiveness to deliver high ... and for the future of science, we're in. Are you?About the Role:The Director , Global Medical Training Strategy will be responsible for developing the strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the physiology, pathophysiology and mechanism of action of Novo Nordisk compounds. The Director works closely with Research & Development teams to translate the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during ... scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… 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...you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers… 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...GxP Patient Safety, Compliance & Vendor Oversight within our Clinical , Medical & Regulatory (CMR) organization. This position combines… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …, development of SBOs/KPIs, execution and oversight Partner with Director to implement and execute launch planning strategies, defines and drives NNI ... and frameworks for patient support field teams. This role will oversee program operations, compliance, vendor contracts and relationship management. AD will drive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …functions and sites.Support the development of the GMP Compliance program related to clinical / commercial stage and manufacturing.Support Legend's regulatory ... will be responsible for providing quality oversight over the compliance program within the global quality organization to ensure harmonization, alignment and… more
