- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, ... the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical...as well as the ability to function in a team environment, are essential.- Preferred Experience and Skills: Board… more
- Merck & Co. (Rahway, NJ)
- …Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling team ; Biostats, Molecular Assay teams, and other key LFs to author ... to the following: Hypothesis-building & strategy forming collaborate with stakeholders in clinical development team (s), to formulate testable clinical … more
- Merck & Co. (Rahway, NJ)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... responsible for guiding Product Development Team Leaders and Clinical Directors within their group to ensure that their programs are being executed effectively… more
- Merck & Co. (Rahway, NJ)
- …development projects; and assist the Associate Vice-President/Vice-President and product development team lead in ensuring that appropriate corporate personnel ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility...as the ability to work collaboratively in a cross-functional team environmentNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy… more
- Merck & Co. (Rahway, NJ)
- …development, and validationSelf-motivated with ability to work independentlyProven ability to lead team members of diverse skill sets and backgroundsStrong ... to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions. Lead the Device… more
- Merck & Co. (Rahway, NJ)
- …Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build ... teams, building talent, and shown to be able to motivate, influence scientific team ; lead by example through past scientific / technical expertise).Highly… more
- Merck & Co. (Rahway, NJ)
- …Market Access, Infectious Disease & Ophthalmology will be a member of the GMAx Pharma leadership team and will lead a team across the ID&O portfolio.T he ... Executive Director will work collaboratively across the enterprise and lead the team in development and execution... including marketing and Product Development Teams (PDTs), (ex. clinical , OR and medical affairs), regional and country teams… 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 ... 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)
- …and execution of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate ... leaders and key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders. They collaborate with V&I Outcomes Research,… 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 ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant as needed. The position… more
- Merck & Co. (Rahway, NJ)
- …(m/f/d)The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping to refine these technologies for inclusion into the ... Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.The Assoc.… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... is expected to work cooperatively with the SSO leadership team and SSO partners to drive overall success of...members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and… 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 ... of Biologics. You will work with an immensely creative and collaborative team of scientists and engineers to design purification processes while developing technical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship ... communicate and align and collaborate with cross-functional teams, manufacturing sites, clinical safety and risk management to uphold the highest quality standards… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Merck & Co. (Rahway, NJ)
- …The Pharmacometrics group within QP2 brings an experienced leadership team , deep modeling expertise and state-of-the-art modeling approaches across multiple ... and modalities to drive portfolio impact from discovery through life-cycle management. The team is externally visible and continues to be at the leading edge of… more
- Merck & Co. (Rahway, NJ)
- …achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a ... platform. You will collaborate with an immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture processes while… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead ... management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip ... for ensuring oversight of Central Monitoring activities according to the Clinical Monitoring Plan inclusive of trend identification, impact assessments and creation… more
