- 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)
- …discoveries in the field to ensure our Company remains as an industry leader in drug development . The Director provides constructive and timely feedback to ... Description:The Director of Chemical Biotechnologies reports to the Senior Director Chemical Biotechnologies in Process Research & Development Enabling… more
- Merck & Co. (Rahway, NJ)
- …to solve challenging technical problems.-The Director influences the direction of drug development and contributes to program Line-of-Sight (LOS) plans ... in the field to ensure our company remains an industry leader in drug development . The Director provides constructive and timely feedback to close… 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)
- …responsibility and independence in a similar role in pharmaceutical drug development or academiaEducational background in pharmacometrics, pharmaceutical ... MIDD can drive portfolio and regulatory decisionsDeep knowledge of drug development , pharmacokinetics and pharmacology principles requiredPreferred… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science (CS) Group ... be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will...of relevant DS stakeholders on the disease area and compound/ Drug . May serve as speaker for program /… 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)
- …research areas centered around rare diseases and immune disorders. SummaryThe 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
- 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance, drug product and packaging manufacturing sites of DS products. ... DS HQ's in order to ensure the quality of drug products marketed globally and acts as a global...supports Global QA CMO Management and Global QA Audit Program teams.Responsible to ensure that quality improvement initiatives at… 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 ... support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role...for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or… 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Global Commercial Program Head as part of the Technical Operations team based in Somerset, New ... is a key member in the global MSAT organization. This individual will be a program lead / owner for a best-in-class high volume marketed CAR-T product as part of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …knowledge of applicable US and EU regulatory requirements and of the drug development process Experience in building and maintaining effective relationships ... Vice President, Medical & Science. Work with the VP Medical/Scientific Development , Clinical Operations, Non-Clinical Research, Medical Writing, Program … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical/scientific training of relevant DS stakeholders on the disease area and compound/ Drug . May serve as speaker for program / franchise medical/scientific ... Science function. This position may be at the executive director level or senior director level, depending...depending on the scope and size of the asset program . This Clinical Science (CS) lead will be responsible… more
