- Merck & Co. (Rahway, NJ)
- …& Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire ... of business development assessments of external opportunitiesThe Senior Director May: Supervise the activities of Clinical Scientists in the execution… more
- Merck & Co. (Rahway, NJ)
- …other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projectsThe Executive Director may supervise ... manage and oversee the entire cycle of late stage clinical development from Phase 2 to Phase...will interact externally with key opinion leaders.-Specifically, the Executive Director may be responsible for:Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... product development process & connectivity between functions supporting pipeline (ie clinical development , CMC, supply chain, & human health), and balancing… more
- Merck & Co. (Rahway, NJ)
- …and Clinical Safety (GRACS) and external to GRACS.Key functions:Reports to Senior Principal Scientist ( Senior Director ) and/or Distinguished Scientist ... Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is... experienceM.D. with minimum of 3 years relevant drug development experience or clinical experiencePhD/PharmD with minimum… more
- Merck & Co. (Rahway, NJ)
- …HTA submissions. The incumbent is expected to work cross-functionally with clinical development , medical affairs, biostatistics, market access, commercial and ... Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , DCT Leadership position in our company's Manufacturing Division is a dedicated full-time role and is accountable for leading the DCT at ... and strategic responsibilities, as it entails guiding drug product candidates from development to launch in line with enterprise priorities.-As the DCT leader, the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking applicants for a Principal ... our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the...scientific role tasked with working closely with the group Director to define group strategy and to lead a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, execution, ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines… more
- Formation Bio (New York, NY)
- …own the IP function for our rapidly growing pharma company. Reporting to the Senior Director , you will operate autonomously to create and execute proactive IP ... can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical ... centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational...the associated budget meet the needs of the overall development plan agreed to by the Global Project Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible line functions. Set the strategic direction to define best approach for clinical development systems, PV systems and MA systems including data ... centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV...years of professional experience in Quality, IT compliance and clinical development in the pharmaceutical industry with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA ... in patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project ... 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)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …evolution and implementation of training curriculum and workshops. In addition, the Associate Director will be involved in the development /training of field ... areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial protocol development and reviews ( clinical trial ... immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance… more
- Eisai, Inc (Nutley, NJ)
- …programming and JReview within IODS. Reporting to the Assoc. Director of Clinical Programming is the senior level highly technical SAS and JReview ... profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in...require excellent technical skills in SAS systems and application development and experience. The Associate Director must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... to the highest quality standards. This position reports to the Head, Global Development and Medical Affairs QA RDPVQA, and oversees multiple levels of direct reports… more
