- Sun Pharmaceutical Industries, Inc. (Blawenburg, NJ)
- Associate Director , Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director , ... process, and contract review. Act as primary point of contact from clinical operations for assigned trials. Oversee study start up activities of CROs (eg… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of Phase I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always ... for the development and control of functional budget in support of global operations of RD unit. Partner with global function leaders to ensure budgets are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... and Regulatory Liaisons to ensure successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyFor late-stage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Merck & Co. (Rahway, NJ)
- …responsibilities include supporting the engineering and maintenance aspects of clinical operations , including support/initiation and gatekeeping of work ... Areas supported include Oral Solid Dosage (OSD) and Sterile operations , the RY119 Development Center, and Global Clinical... operations , the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Merck & Co. (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of ... is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with… more
- Merck & Co. (Rahway, NJ)
- …strong understanding of engineering fundamentals. The Process Supervisor position will report to the Associate Director , MACS Operations and will be a member ... process supervisor role at the Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This… more
- Merck & Co. (Rahway, NJ)
- …and project management responsibility. The Specialist -Engineering position will report to the Associate Director , Engineering and will be a member of the EF ... interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring new technologies. -… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …process improvements, procedural documents, and quality and inspection readiness for Clinical Operations . The Associate Director , will be a key member of ... (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Bristol Myers Squibb (Summit, NJ)
- …your career, and the ability to help patients are incredible. **The Position:** The Associate Director , North America Operations and Global Process Support, ... handling of patient treatment schedules for Bristol Myers Squibb's clinical and commercial Cell Therapies in North America. The... and commercial Cell Therapies in North America. The Associate Director , North America Operations … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...preferred Experience Qualifications + 1 or More Years of clinical experience preferred _Daiichi Sankyo, Inc. is an equal… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The ** Associate Director , Cryo Operations ** leads a team of Senior Managers, Managers, ... inventory management and strategic outlook for the space within CAR T clinical and commercial operations in Summit, NJ. This position plays a critical role in… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The ** Associate Director , Cleanroom Operations ** , leads a team of Senior Managers, ... associated with GMP cleaning & EM Sampling within CAR T clinical and commercial operations in a several cGMP multi-cleanroom suite as well as control/enhancement… more
