- Daiichi Sankyo, Inc. (Bernards, NJ)
- …college or university)MD is required. Basic QualificationsAt least 15 years of professional drug development experience in a major pharmaceutical company, ... representative with key high-level internal and external stakeholders on important drug safety issues supporting Global Medical Safety Lead. Responsible for safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary The Sr Director GPM&L is accountable for delivering an integrated drug development strategy and tactical plan including options analysis of team's proposals ... ResponsibilitiesIndependently manage or lead strategy development for high complexity drug development projects/programs. Manages the Global Project Team(s) in… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleThe Associate Director, Professional Promotion, Gyn-Onc will develop and implement brand strategies and ... the gyn-onc space. This critical role will report directly to the Director, Professional Promotion, Gyn-Onc and be expected to work closely with Gyn-Onc Consumer… more
- Merck & Co. (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a candidate for the position of ... late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization… more
- Merck & Co. (Rahway, NJ)
- …part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology ... 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)
- …which focuses on the design, development, and commercialization of novel biologic/ drug /vaccine-device combination products for safe and effective delivery to their ... products. This position also supports other critical activities such as drug product and combination product final assembly processes validations. All activities… more
- Merck & Co. (North Wales, PA)
- …with scientific literature, and support the company's mission to foster innovation in drug discovery and development. The Director will be a player-coach, guiding a ... goals and providing ongoing development and feedbackEnthusiasm for continuous personal professional development, staying abreast of industry trends, and applying new… 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 QP2 brings an experienced leadership team, deep modeling expertise and… more
- Insmed Incorporated (San Diego, CA)
- …guidance to the PV scientists on decisions that have significant drug safety implications, including safety signal detection activities of monitoring, evaluation, ... Performs thorough assessment of safety profiles for Due Diligence project(s). Provides Drug Safety input for product recall issues or Health Hazard Evaluations and… more
- Merck & Co. (Rahway, NJ)
- …& Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... set direction for the device development strategy for multiple drug -device combination product development programs ranging from concept generation/selection,… more
- Merck & Co. (North Wales, PA)
- …human health.This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of one ... processes (SOPs) and software development life cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Genmab (Plainsboro, NJ)
- …mechanisms that allow optimization of product development (eg, orphan drug designation, breakthrough therapy designation, PRIME, Fast Track, accelerated/conditional ... Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders Participate in review of and… more
- Merck & Co. (Rahway, NJ)
- …biology and high-level scientific concepts and approaches, clinical research and drug discovery and development. Furthermore, this leader is dedicated to ... digestible and accurately report the informationServe as an effective and professional company spokesperson to key media and internal audiencesDeliver strategic… more
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development ... for partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be assigned to any therapeutic area and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Master's Degree preferred Experience QualificationsMust have 7+ years of professional industry experience in pharmaceutical operation including first-hand knowledge ... of drug manufacturing, packaging, QA, compliance, and auditMust have a proven track record of implementing large-scale process improvement initiatives, including… more
- Genmab (Plainsboro, NJ)
- …manage, mentor, and develop Global Trial Leads (GTLs), fostering professional growth.Forecast and manage Clinical Trial Management resources including GTLs, ... and knowledge of tools and processes.Previous experience with oncology drug development process in various phases of development.Regulatory submission… more
- Genmab (Plainsboro, NJ)
- …PhD or MD required. Certification as a Medical Publication Professional (CMPP) desirable.Oncology/Hematology experience strongly preferred.7+ years in medical ... publication strategy, planning and execution during all phases of drug development and commercialization process.Demonstrate an understanding of clinical research… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... active participation and identification of compliance gapsObtain and maintain professional and technical knowledge by attending educational workshops; review … more
