- 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)
- …Director US Medical Affairs (USMA) Oncology, under the direction of the Senior Director , USMA Oncology (US Medical Affairs team lead for compound), is ... budgets and resources for the assigned medical affairs plan activities, in collaboration with Sr. Director .- Leads medical readiness activities for market… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety ... rare diseases and immune disorders. Summary: Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s),… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, ... ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,-… 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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop ... mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Merck & Co. (Rahway, NJ)
- …pricing and reimbursement strategy for our ophthalmology products. In this role, the Director will lead the development and execution of global market access ... value proposition, pricing strategy, and payer/stakeholder communication tools in collaboration with Commercial, Clinical Development, Outcomes Research, Medical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant ... Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products… more
- Merck & Co. (Rahway, NJ)
- …data-driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director , DSCS Digital Project Manager, will be ... Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS)… more
- Merck & Co. (Rahway, NJ)
- …your team in the development of project management, communication, and collaboration skills in support of our clinical trials.Job ResponsibilitiesResponsible ... execution and conduct of clinical trial(s).Serves as the Clinical Trial Team lead . Leads and directs teams in key study planning, development, and… more
- Merck & Co. (Rahway, NJ)
- …the Associate Director of Launch Strategy and Operations, you will lead the enterprise preparation of multiple product launches in Immunology. You will ... Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper Gwynedd), PennsylvaniaDivision: Human Health US (HH-US)Therapeutic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director Pulmonary Hypertension, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) (referred to as EDMA) is ... for their assigned Therapy Areas (TA). They build and lead a team of TA dedicated global and regional...all Research & Development (R&D) V&I staff globally in collaboration with V&I Outcomes Research through the global Value… more
- Merck & Co. (Rahway, NJ)
- …decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate ... Director will work with scientists within QP2 by applying...PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into… more
- Merck & Co. (Rahway, NJ)
- …that accelerate the decision-making process from hit identification to clinical candidate delivery across different therapeutic areas and modalities at ... statistics, and cheminformatics techniques to improve hit identification and hit-to- lead processes for different screening technologies (mRNA display, DNA-Encoded… more
- Merck & Co. (Rahway, NJ)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical ... clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the… more
- Merck & Co. (Rahway, NJ)
- …/scientific execution of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical ... clinical data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in… more
- Merck & Co. (New York, NY)
- …to patient enrollment and retention efforts to achieve study milestones.Protocol lead responsibilities in collaboration with GCTOAddresses questions from ... Job DescriptionPosition ResponsibilitiesThe Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cutting-edge therapeutics for patients worldwide.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C… more
