- Merck & Co. (North Wales, PA)
- …health.- Responsibilities: This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include ... leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which range from… more
- Merck & Co. (Rahway, NJ)
- …the technical leadership and laboratory capabilities in support of late -stage pipeline commercialization and post-market commercial manufacturing support. BDSC ... conjunction with internal and external partners, this individual will support late stage and commercial large molecule biologics program activities. The individual… more
- Merck & Co. (Rahway, NJ)
- …across functions to drive defined milestones. Support both early and late -stage development candidates, including screening and development of robust drug product ... of critical attributes, and technology transfer of early phase and/or late phase drug product manufacturing processes to GMP production facilities. Experience… more
- Merck & Co. (Rahway, NJ)
- …plus growth of existing products. This position will involve oversight of late -stage method development, validation, and life-cycle management of methods but mainly ... compendial chapters required for method transfer and validation.Knowledge with late -stage method development, validation, and transferMinimum two years working… more
- Merck & Co. (North Wales, PA)
- …are in various stages of development therefore requiring someone who has late vaccine clinical development and lifecycle management experience.The AVP will also be ... with functional experts across the enterprise to ensure operational excellence in the late development of assets within the pediatric section of the Vaccine Clinical… more
- Merck & Co. (Rahway, NJ)
- …Knowledge of manufacturing, testing, quality, and supply chain processes from late clinical development through commercialization, with practical insight into how ... authoring. - Familiarity with CMC operations and technology transfer from late clinical development to commercialization (manufacturing, testing, quality, supply). -… more
- Merck & Co. (Boston, MA)
- …the diagnostics strategy, bridging the continuum from Discovery Research through Late -Stage Clinical Development. The successful candidate will have an essential ... not already available.Interact at all stages with Early Development and Late -Stage stakeholders to ensure strategic alignment.Conceive and develop CDx strategies for… more
- Merck & Co. (Cincinnati, OH)
- …research and publication in Virology is highly desirable (ie, experience in late stage clinical research as an investigator or key study personnel conducting ... outcomes research, company sponsored trials, or investigator-initiated trials).5+ years of prior pharmaceutical industry experience (MSL or other clinical, medical or research related position) in VirologyPrior working experience within the coverage region and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diagnostics (CDx) in support of multiple projects within Daiichi Sankyo's Oncology Late -Stage Development Portfolio. The individual will play a key role in making ... Precision Medicine a reality for patients who are likely to benefit from our therapeutics. Responsibilities: Acts as CDx representative to the Global Project Team (GPT) for any projects that definitively require a CDx for drug registration or for any project… more
- Merck & Co. (Boston, MA)
- …in this role, you will serve as the translational lead on late -stage immunology programs, driving the Precision Medicine objectives in alignment with clinical ... development plans. Collaborating with Discovery, Translational Medicine and Product Development Teams, you will be the authority in defining and interpreting the translational experiments and data generated respectively from our clinical trials, and… more
- Merck & Co. (South San Francisco, CA)
- …on cardiometabolic and ophthalmology discovery, early clinical development and late clinical development teams, leveraging quantitative approaches to drive ... streamlined development of programs within our growing ophthalmology portfolio. Collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact… more
- Merck & Co. (Rahway, NJ)
- …pathology algorithms.Interface with scientists and physicians in early and late -stage clinical development to execute histopathology-based biomarker strategies in ... clinical trials.Establish new histopathology-based assays in the laboratory as part of a team.Provide subject matter of expert pathologist input to discussions in a highly matrixed environment, collaborating with internal and external stakeholders.Position… more
- Eisai, Inc (Nutley, NJ)
- …real-world, health economics outcomes data. This role primarily focuses on late -stage pipeline and marketed products, interfaces with cross-functional teams and ... partners with the research HEOR field team in the execution of customer centric research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate utilization based on generation and… more
- Merck & Co. (Rahway, NJ)
- …execute strategic plans for technology transfer, problem-solving, leading teams in late stages of development, and working collaboratively with external and internal ... partners.Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed,… more
- Merck & Co. (North Wales, PA)
- …EDSA leads a large investigator-initiated studies program in partnership with late -stage development teams in Medical Affairs while also supporting early-stage ... development teams. The role also partners with Medical Affairs leadership to develop the global Value Evidence And Medical (VEAM) Planning strategy across designated therapeutic areas. The EDSA has a key role at major Congresses, including, but not limited to,… more
- Merck & Co. (Rahway, NJ)
- …new or marketed cardiovascular and respiratory medicines. With a focus on late -stage development, the Senior Director will manage the entire cycle of clinical ... development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre-clinical and translational work for the purpose of generating early… more
- Merck & Co. (Rahway, NJ)
- …strategic plans for technology transfer, problem-solving, leading working group in late stages of development, and working collaboratively with receiving sites, drug ... product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design.- Provide information and drive early alignment and… more
- BioAgilytix (Boston, MA)
- …proactively informing Customer Service of any issues which may cause late results.Performing and documenting routine equipment use, maintenance, calibration as well ... as routine, scheduled, and unscheduled preventive maintenance.Participating in method development and equipment qualification activities as directed by Laboratory Management.Supporting audits, inspections, and assisting in responding to observations, if… more
- Merck & Co. (Boston, MA)
- …post-licensure). The Senior Director will manage the entire cycle of late -stage clinical development and studies, including development strategy, study design, ... initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and… more
- Merck & Co. (Rahway, NJ)
- …phases of clinical development (pre-clinical to post-licensure). With a focus on late -stage development, the Senior Director will manage the entire cycle of clinical ... development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting.- They will provide internal scientific leadership for cross-functional areas supporting… more
