- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, ... are not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory,… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to ... to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of pharmacometricians with diverse… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory strategy ... submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the regulatory single point-of-contact for… more
- Merck & Co. (Rahway, NJ)
- …at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs… more
- Merck & Co. (Rahway, NJ)
- …are seeking a highly skilled and motivated Associate Principal Scientist/Associate Director with expertise in conducting outcome researching using real world data, ... models to extract meaningful insights and outcome research evidence. Unstructured Clinical Data: Utilize transfer learning, fine tuning, GAN, transformer, attention,… more
- Merck & Co. (Rahway, NJ)
- …global lawmakers on industry best practices and requirements for effective global clinical research.Co- lead our network of 250+ Global Privacy Stewards who ... -The primary responsibility of the Deputy Chief Privacy Officer is to lead the team responsible for internal and external stakeholder engagement, working in… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs...the PositionAs Formation Bio's dedicated IP Counsel at the Director level, you will own the IP function for… more
- Formation Bio (New York, NY)
- …will also provide analytical development oversight of pre- clinical and clinical -stage large molecule asset acquisitions and lead analytical activities at ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manual (PM) template with inputs from internal and external stakeholders. Collaboration with external stakeholders (eg, research pharmacists, clinical study ... and operational excellence; Provide input in Patient Focused Initiatives in close collaboration with RD colleagues.Drive discussions with Clinical Operations and… 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 ... development through to commercial manufacturing.- Deep understanding of connectivity between clinical , CMC, and HH to successfully launch a new product. Technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones ... 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)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management,...Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, ... centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in ... impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected. Experience in leading small groups of technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Job Summary: The TA Oncology Strategy and Execution Lead is a pivotal leadership role responsible for driving the strategic and ... TA Oncology organization The incumbent will be expected to independently lead cross functional initiatives intended to build capabilities, improve processes, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory questions from Global Health Authorizes (HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners to ensure robust ... drug-related CDx topics/questions, and attend device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the Dx partner for CDx project contracts. Supports CDx analytical and clinical validation studies in collaboration with Dx-partner Provides scientific and ... ensure successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... be responsible for the internalization and oversight of the RBQM model. Collaboration and partnership with other functions and stakeholders in supporting clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication ... with clinical sites in collaboration with clinical development staff.Consults with KEE's...KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the… more
