- Merck & Co. (Rahway, NJ)
- …we are seeking a dynamic talent to serve in the role of Associate Director , Data Science as part of Impact Assessment and Investment Optimization (IAIO) ... team.The position of Associate Director - Data Science as a functional area ...behavioral segments, Promotional reply models, Return on Investments, impact assessment for physician- and patient-directed promotional programs and Marketing… more
- Merck & Co. (South San Francisco, CA)
- …are seeking an exceptional and experienced leader in the role of Director of Biologics Analytical Characterization and Developability in the Protein Sciences ... Department within the Discovery Biologics at our South San Francisco site.- The Director will be responsible for the leadership of a team of 10+ scientists (group… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPrincipal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director /Senior Director , the ... support of their assigned projects. Position Description- The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Medical Director serves as the subject matter expert for our products and related data within a ... Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspective- May provide clinical input into the eCRF ... data review per Integrated Data Review Plan (IDRP)- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... / amendments and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Director , Diagnostic Sciences Global Companion Diagnostics Job Summary The Director ... assays and partners and will contribute to design and execution of technical assessment of assays, vendors, and specialty laboratories. This individual will work in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role is responsible ... develop an Integrated Evidence Plan (IEP), which includes an evidence gap assessment , gap prioritization and strategic delivery plan. The plan integrates the global/… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspectiveMay provide clinical input into the eCRF (Case… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Market Access, Immunology T he Director , Global Market Access, Immunology will play a leadership role in ... assets within our Immunology portfolio. In this role, the Director will lead the development and execution of global...on an ad-hoc basis.Partner with Policy colleagues in the assessment of and development of action plan to shape… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs, Evidence Generation role is responsible for ... develop an Integrated Evidence Plan (IEP), which includes an evidence gap assessment , gap prioritization and strategic delivery plan. The plan integrates the global/… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this position ... acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from… more
- Merck & Co. (North Wales, PA)
- …effective implementation and continuous improvement and assist in the continued assessment and evolution of the Marketing chapter model. Key Qualifications: ... Marketing Mastery: A minimum of 8 years of experience in marketing, with proven success in working on launches and delivering business results.Leadership Excellence: Demonstrated experience in coaching, mentoring, and developing teams, with a passion for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and quality ... check of data, Works with BD&O to ensure SAP updates; Responsible for valid clinical interpretation of study results as Clinical Study Leader, medical monitor or regional clinical/Translational Medicine and Clinical Pharmacology representativeExternal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and quality ... check of data, Works with BD&O to ensure SAP updates; Responsible for valid clinical interpretation of study results as Clinical Study Leader, medical monitor or regional clinical/Translational Medicine and Clinical Pharmacology representative.External… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …handling straight-forward CSPV tasks such as single event level AE causality assessment . This position requires manager review and gains industry knowledge through ... multiple opportunities. ResponsibilitiesSafety Expert - Overall: Develops safety knowledge working closely with CSPV management.Safety Expert - Signal Identification: Carries out routine signal identification activities formulated by manager. Uses medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database ... lock and quality check of data; Works with BD&O to ensure SAP updateExternal collaboration: Consults with internal experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget; Establishes effective… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems are in place and in some areas ensure that an internal QA assessment of research notebooks for compliance oversight is in place and all regulations being ... adhered to.Ensure that Clinical Development activities (ie , protocols) are aligned with GLP/GCLP, FDA, ICH, EMA, PMDA regulations/ standards and guidance.Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering… more
