- Merck & Co. (Rahway, NJ)
- …in one of the above disciplines plus 5 years related experienceExperience with the development drug -device combination product or a medical device component of a ... Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and effective… more
- Merck & Co. (Rahway, NJ)
- …and Quality by Design principles, and advanced data analysis for drug development applications.- Requirements: Ph.D. in biochemistry, analytical chemistry, ... DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion… more
- Merck & Co. (Rahway, NJ)
- …FDA; prepare our company's teams for meetings with FDA at any phase of drug development . Lead cross-functional efforts to prepare for advisory committees and may ... in biological science or related disciplineB.S., with minimum of 7 years of relevant drug development experienceM.S. with minimum of 7 years relevant drug … more
- Merck & Co. (Rahway, NJ)
- …Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development . Experience with small molecule drug substance and/or biologics ... Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during… more
- Merck & Co. (Rahway, NJ)
- …of trials, clinical trial design and Go/No Go decisionsFraming critical drug development questions for optimizing model-informed development -Responsible ... responsibility and independence in a similar role in pharmaceutical drug development or academia.-Educational background in pharmacometrics, biopharmaceutics,… more
- Merck & Co. (Rahway, NJ)
- …drug conjugate, fusion protein).Knowledge and experience in Antibody Drug Conjugate method development .Established scientific reputation supported by ... Job DescriptionThe Biologics Analytical Research & Development department of our company's Research Laboratories Division...scientific role tasked with working closely with the group Director to define group strategy and to lead a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.SummaryThis position is responsible for providing project management, drug development expertise to Global Project Teams including strategic ... Global Team leader as the Project Management lead on drug development projects. This position can be...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… more
- Insmed Incorporated (Bridgewater, NJ)
- …functions within pharmaceutical or biotech companies that are directly related to drug development and clinical trialsFundamental understanding of GCP, GLP, and ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Development Strategic Initiatives will work with the… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …seeking an Associate Director Immuno-Oncology as part of the Research and Development team based in Piscataway, NJ. Role Overview Legend Biotechnology is at the ... therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy... to lead our in vivo CAR-T cell therapy program . If you're passionate about advancing groundbreaking treatments and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of established and new assay technologies such as NGS, IHC, PCR etc.Knowledge of drug development process and an understanding of how diagnostic development ... of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role...teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other government and local agencies required- 10+years of working knowledge of the end-to-end Drug development process in the R&D space required- 10+ years of ... research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization ... of relevant DSI stakeholders on the disease area, competitive landscape, and compound/ drug . May serve as speaker for program / franchise medical/scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and other vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. This position provides leadership ... ensures quality delivery of medical coding for clinical trials, clinical development , and regulatory submissions. Develops and proposes strategies for medical coding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred- Demonstrated success in planning and executing strategies for global drug development , commercialization, and life cycle management preferred- Strong ... plus emerging pipeline assets to advance our research and development . This role will lead workstreams with highly matrixed...work to support critical strategic choices for the clinical program . The DAST Director will collaborate with… more
- Insmed Incorporated (Bridgewater, NJ)
- …of activities associated with delivering on Insmed's assets through completion of the drug development and launch processes. This position will be accountable ... required for the successful and timely completion of cross-functional plans. The Sr. Director of Program Management will utilize best-in-class program … more
- Tris Pharma (Monmouth Junction, NJ)
- …related to Pain programs and assists, as appropriate, in other therapeutic area program development (ie, substance use disorders, ADHD, etc.); Designs and ... Detailed understanding of the pharmaceutical industry, including but not limited to: drug development and regulatory processes and ability to apply knowledge… more
- Insmed Incorporated (Bridgewater, NJ)
- …record of successfully leading toxicology programs through various stages of drug development . Experience in toxicology on biologics, oligonucleotides, and/or ... collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development , CMC, and program management to drive the overall… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program . The Director will provide high level strategic input into ... development plans, study designs, and regulatory submissions. The Director will provide direction and mentoring to other members of the Medical Writing team.… more
- Insmed Incorporated (Bridgewater, NJ)
- …PK, PK/PD and pharmacometric analyses for clinical and non-clinical studiesApply model-based drug development strategy to support clinical dose and dosing ... PKPD principles, ADME concepts, and clinical pharmacologyThorough understanding of overall drug development programs and familiar with clinical pharmacology… more
