- Formation Bio (New York, NY)
- … trial execution model. In-depth knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines. Strong strategic thinking and analytical skills. ... platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio...PhD, MBA) in a related field. Preferred: Experience with global clinical trials and regulatory submissions. Formation… more
- Formation Bio (New York, NY)
- …built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or ... AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug ...progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately… more
- Genmab (Plainsboro, NJ)
- …collaboration, excellence, and a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, ... an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical Drug Supply… more
- Genmab (Plainsboro, NJ)
- …possible outcomes for patients.The position reports to the Director of Global Clinical Drug Supply Operations based in Copenhagen.ResponsibilitiesManage ... an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations in Copenhagen or Princeton. The position requires… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... our Research & Development Division portfolio of clinical trial s .- GCS is accountable for the...the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly… more
- Merck & Co. (Rahway, NJ)
- …in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects ... registration. Associate Directors are emerging leaders in the field of quantitative drug development, with a developing understanding of the strategic elements of … more
- Merck & Co. (Rahway, NJ)
- … clinical trial design and Go/No Go decisionsFraming critical drug development questions for optimizing model-informed development-Responsible for developing and ... Job DescriptionAssociate Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient ... drug discovery/development and/or regulatory decisions. The Pharmacometrics group within...our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented… more
- Merck & Co. (Rahway, NJ)
- …DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development Team designs, ... develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of… more
- Merck & Co. (Rahway, NJ)
- …Scientist (Executive Director ) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and ... , PDT Lead may:-Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.-Supervise the activities of entire … more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager, Team Manager (GCTM-TM) is responsible for line ... operational and strategic support across trials as needed and may assume Global Clinical Trial Manager (GCTM) responsibilities to address fluctuating demands… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and always seeks to improve working procedures, quality, and output. The Strategy Director serves as the clinical development strategy lead for pipeline ... Global HQ and NNI. In addition, the Strategy Director may represent NNI on Global Project...needed. Relationships This position reports directly to the Executive Director , Clinical Development Strategy (CDS) and will… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Director Global Market Access & Pricing Hematology will be responsible for ... Princeton NJ (US) and will report to the Senior Director Global Access and Pricing. ResponsibilitiesLead the...of assigned asset(s),Provide strategic market access input to inform global clinical development program of assigned asset(s)… more
- Genmab (Plainsboro, NJ)
- …with the Genmab valuesAdditional Job Description Develop and execute sound and robust Global Regulatory strategies for drug products at various stages of ... for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance ... products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies.Reports to Senior Director in the General Medicine… more
- Genmab (Plainsboro, NJ)
- …plan.Strong leadership presence and the ability to work effectively with other clinical and scientific experts at Genmab. Global perspective and mindset; ability ... drug development and commercialization process.Demonstrate an understanding of clinical research principles and disease state knowledge.Ability to drive and… more
- Genmab (Plainsboro, NJ)
- …needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory, and other cross ... matter expert in both internal and external venues such as the US/ Global cross-functional teams, clinical development teams, advisory boards, professional… more
- Merck & Co. (Rahway, NJ)
- …Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and… more
- Genmab (Plainsboro, NJ)
- …for an experienced and dedicated Medical Director to be a part of our Global Clinical Development Team.The Medical Director will be accountable for the ... medical oversight of one or more clinical trials, medical review and communication of data, and...drug , including the safety aspects of patients in clinical studies and signal detection with support of the… more
- Merck & Co. (Rahway, NJ)
- …science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our ... global team, you will have the opportunity to collaborate...range from early stage up to commercialization for both drug substance and a broad array of oral, sterile… more
