- 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 ... efforts to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of pharmacometricians with… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a… more
- Merck & Co. (Rahway, NJ)
- …business development assessments of external opportunities.Managing other Directors and/or Senior Directors responsible for Atherosclerosis clinical development ... Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in the Atherosclerosis… 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 ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- …units and senior leaders with the ability to influence and lead change while building strong alignment and partnerships.Proven ability to develop and implement ... Job DescriptionUS Lead , Medical Modernization - V&IReporting to the Head of Strategy Realization, Medical Modernization, the US Leader for Medical Modernization (MM)… more
- Merck & Co. (Rahway, NJ)
- …in the Formulation, Laboratory, and Experimentation (FLEx) Sterile GMP Clinical Manufacturing facility.Contribute to equipment and facility design, system ... quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical ...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Eisai, Inc (Nutley, NJ)
- …a team of Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study inspections from preparation through ... we want to hear from you.The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... 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 efforts ... treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role,...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)
- …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
- Merck & Co. (Rahway, NJ)
- …individuals who lead multi-tumor asset teams (asset team leads). Any clinical development staff reporting to the ATL will be indirect reports.Education:M.D or ... corporate goals and providing critical therapeutic area insightsManagement experience in a clinical development settingProven ability to lead a high performance… more
- Merck & Co. (Rahway, NJ)
- …submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the regulatory single point-of-contact for ... products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Key... Safety (GRACS) and external to GRACS.Key functions:Reports to Senior Principal Scientist ( Senior Director) and/or Distinguished… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and ... managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical … more
- Merck & Co. (Rahway, NJ)
- …data is critical for GRACS and other critical stakeholder areas including PV, Clinical and Supply Chain to ensure that datasets are complete and consistent. Having ... key c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level...are not limited to: - - Data Centric Submissions: Lead the data submissions team that is accountable for… more
- Merck & Co. (Rahway, NJ)
- …continuity of supply, and commercial outcomes.The VCM Product Manager will help lead the cross-functional Supply Chain Working Group (SCWG) for pipeline products or ... or Value Chain Management Team (VCMT) for commercial productsSupport and/ or lead commercial siting selection, supply chain design, and value stream mappingAssist in… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics… more
- Merck & Co. (Rahway, NJ)
- …development through to commercial manufacturing.- Deep understanding of connectivity between clinical , CMC, and HH to successfully launch a new product. Technical ... and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of… more
- Merck & Co. (Rahway, NJ)
- …development through to commercial manufacturing.- Deep understanding of connectivity between clinical , CMC, and HH to successfully launch a new product. Technical ... and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of… more
