- Merck & Co. (North Wales, PA)
- …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 individual clinical… more
- Insmed Incorporated (NJ)
- …to provide executional oversight and coordination of one or more global, late- stage program(s). Working in close partnership with the Senior Director, Program ... not required.Experience and knowledge in the drug development process with late- stage experience a distinct advantageStrong interpersonal skills with the ability to… more
- Merck & Co. (Rahway, NJ)
- …responsibilities:Shape and align biomarker strategies for early and late- stage clinical programs, emphasizing clear hypotheses, fit-for-purpose readouts, and ... matter experts to translate disease biology and drug mechanism into clinical stage biomarker plans that address key program questions and integrate diverse technical… more
- Merck & Co. (Durham, NC)
- …(instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi- stage refrigeration systems).Required Experience and Skills:Familiarity of regulatory ... requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsPhysical requirements - Must be willing and able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level. Walking,… more
- Formation Bio (New York, NY)
- …screen through confirmatory diligence and integration. This role will lead late- stage diligence efforts, support asset onboarding post-acquisition, and help build ... and clear action tracking. Flex Capacity (Post-Acquisition Support) Support early- stage execution for newly acquired assets, coordinating integrated development… more
- Formation Bio (New York, NY)
- …team. In this role, you will lead our toxicology efforts, supporting late- stage drug development and contributing to business development activities. You will be ... industry Proven track record in leading toxicology efforts in late- stage drug development Strong understanding of regulatory requirements for toxicology… more
- Cipla (Fall River, MA)
- …etc. Act as the custodian of the project governance process. Responsible for stage -gate reviews and escalation of topics, as required. Responsible for maintaining a ... implement a risk-based approach towards assessment of projects, project milestones and stage gate reviews. Lead and/or participate in conducting data and hypothesis… more
- Insmed Incorporated (NJ)
- …trainings).Experience working in a biotech startup or high-growth clinical- stage company.Familiarity with computer system assurance (CSA) principles.Pay ... Range:$133,000.00-173,000.00 AnnualLife at InsmedAt Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how… more
- Insmed Incorporated (NJ)
- …with clinical and forecasting teams to translate patient journey insights, late- stage clinical outcomes into robust commercial forecasts with scenario planning ... focused on market access, competitive landscape and uptake modelsIntegrate payer landscape analyses into GTM scenarios to anticipate access hurdles and contracting impactsPartner with Field Strategy & Operations to align targeting/segmentation outputs with… more
- Cipla (Fall River, MA)
- …Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures. Execute acceptable quality ... limit (AQL) sampling and inspections as required. Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and follow detailed documentation procedures to deliver the results to the QC Lab. Maintain records of… more
- Merck & Co. (Durham, NC)
- …(instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi- stage refrigeration systems).Required Experience and Skills:Familiarity of regulatory ... requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsPhysical requirements - Must be willing and able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level. Walking,… more
- Shimadzu Scientific Instruments (Washington, DC)
- …and discretionary yearly contributions, with detailed information provided at the final interview stage . In your first year, you will receive 10 paid vacation days, ... 8 paid personal days (or state sick leave in California/Puerto Rico), 8 scheduled holidays, and 3 floating holidays. After one year, you'll have access to a generous short-term disability program, with premiums fully covered by the company. Employees are… more
- Merck & Co. (Rahway, NJ)
- …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. (MA)
- …activities involving investigational compounds in Immunology. With a focus on late- stage development, the Senior Clinical Director will manage the entire cycle ... of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible… more
- Merck & Co. (South San Francisco, CA)
- …tracers in early clinical oncology trials, guiding projects from late- stage preclinical work through clinical proof-of-concept studies. Translational study design ... : Design, oversee, and interpret PET imaging studies in animal models and early-phase clinical trials (Phase I), ensuring robust study design and high-quality PET data collection. Regulatory support : Familiarity with regulatory and quality frameworks… more
- Merck & Co. (Rahway, NJ)
- …through the early research and proof-of-concept phase up to the development stage . She/he/they will interface with researchers and senior management throughout the ... organization as well as external partners and operate within a matrix structure to garner resources for the necessary research work (Medicinal and Process Chemistry, in vitro Pharmacology, Pharmacokinetics, Disease Models, Formulation Development, Safety &… more
- Merck & Co. (Rahway, NJ)
- …processing and recombinant expression of drug candidates in early- and late- stage development.Responsibilities include, but are not limited to:Serve as a scientific ... leader to shape and drive innovation across the Biologics pipeline, strategy, and science.Anticipate and solve scientific and technical challenges across projects and functional teams, in a fast-paced, multidisciplinary environment.Lead the development of… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late- stage development, the Clinical Director will manage the entire cycle of ... clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be Responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …forecasts and assumptions,Champion the integration of commercial assessments for early- stage assets, providing strategic input to support portfolio prioritization ... and resource allocation.Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable… more
- Bayer (Chicago, IL)
- …services where relevant. Manage trade-offs between functionality, speed, and scalability in early- stage builds. WHO YOU ARE Bayer seeks an incumbent who possesses ... the following: Required: 10+ years (MS 8+ or PhD 6+) of hands-on experience in software development Full-stack development experience with React, Python, and/or Java. Cloud deployment experience with Azure (required); AWS is a plus. Infrastructure-as-code… more
