- Merck & Co. (Boston, MA)
- Job DescriptionThe Executive Clinical Director (Distinguished Scientist) has primary responsibility for the strategic planning and directing clinical ... investigational compounds in Immunology. With a focus on late-stage development, the Executive Clinical Director will manage the entire cycle of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within ... and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management ... of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence...for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Strategic Planning provides strategic insights ... input and prioritization rankings via presentation of Forecasts/Assumptions/NPVs and comparative Clinical value where possible. Lead BSA Forecasting team members… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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...Responsible for Strategic Application product roadmaps to meet business objectives. Lead the definition of solutions based on business needs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies. Partner with ... always maintained and accurate. Accountable to the Global Team Lead (GTL) and GPT (Global Project Team) for the...with organizational strategies and objectives.- People Leadership - May lead small team; Coach, motivate and develop staff to… 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 ... on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director , Alliance Management.Tris Pharma has a long track record of ... spanning many departments across all stages of the product lifecycle. The Associate Director , Alliance Management will be accountable for managing alliances… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …forefront of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewJoin the Technical Operations team as an Associate Director of MSAT where you will support pipeline programs ... activities, coordination of process start-up activities including Engineering Runs, GMP/ clinical , PPQ and routine commercial runs, and resulting risk mitigation… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a ... approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Line management of Senior Global Safety Lead (s), Global Safety Lead (s) and Global Safety Scientist(s)/ Associate within Safety Surveillance. Essential ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Executive Director , Global Medical and Scientific Affairs (EDMA) GYN Malignancies is accountable for the development and execution of scientific & ... (V&I) plans for their assigned Therapy Areas (TA). They lead a team of TA dedicated global and regional...team of TA dedicated global and regional directors and associate directors. The EDMA engages with global scientific leaders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for operational improvements and seek agreement through consensus management.RelationshipsReports to an Associate Director / Director within the NNI ... systems, tools, processes, policies and procedures to support and lead to informed, fact based sourcing decisionsPhysical Requirements10-20% overnight travel… more
- Merck & Co. (Rahway, NJ)
- …is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable ... is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with… more
