- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clear and sustainable platform of evidence generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient ... is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development...a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing… more
- Merck & Co. (Rahway, NJ)
- …for:-Evaluating pre- clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug ... or marketed Oncology medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will… more
- Merck & Co. (North Wales, PA)
- …Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early /Late Development Statistics, Statistical Programming, , and other company ... and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, ... multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, ...the associated budget meet the needs of the overall development plan agreed to by the Global Project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory, ... and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the… more
- Insmed Incorporated (Bridgewater, NJ)
- …the company in outside groups.Contribute to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or PharmD ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director, Clinical Development will play an important role in working with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …multidisciplinary pharma/diagnostic development team.- Knowledge of the IVD and/or clinical development process is a plus.- Knowledge of molecular ... implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play… more
- Merck & Co. (North Wales, PA)
- …Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug Development and/or Late Drug Development Teams partnering with ... of integrated project plans appropriate to the project 's phase of development and complexity. This...(eg, MS, MBA, Ph.D., PharmD) preferred.Experience and knowledge of clinical drug development strongly preferred; including the… more
- Merck & Co. (North Wales, PA)
- …partnerships.--Evaluating pre- clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug ... within an Asset team. Our Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage… more
- Merck & Co. (Rahway, NJ)
- …the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams ... control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal… more
- Merck & Co. (Rahway, NJ)
- …and deep understanding of synthetic routes, to inform the selection of early development and market formulation compositions and manufacturing processes, ... of a team develop ing innovative analytical methodologies for early to late phase pro grams with application to...(NDA)/ worldwide marketing application (WMA) submission documents across the project development lifecycle, as well as responding… more
- Merck & Co. (Rahway, NJ)
- …and technologies.To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development , Analytical, Formulation, and Commercial ... robust and scalable upstream processes for biologics in different stages of clinical development , 2) process characterization and regulatory filings for… more
- Merck & Co. (Rahway, NJ)
- …For:Evaluating pre- clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug ... or marketed Oncology medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials. preferred- Having knowledge of all phases of drug development , including early and late phase clinical development and submission preferred- ... set-up preferred- The candidate should have successfully provided programming expertise at the Project level for at least two global development projects that… more
- Merck & Co. (Rahway, NJ)
- …launch and after.The candidate will work closely with value and Implementation teams under clinical development -to ensure all clinical trials include the ... member for Value and Implementation teams and ad-hoc member for Pharmaceutical Development / Early Development teams.Monitor Oncology global competitors and… more
- Catalent (San Diego, CA)
- …pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... Job Title: Scientist, Analytical Development City: San Diego State : CA JOB...discussions with clients on technical topics relating to their project . Supervisor will not need to attend most client… more
- Merck & Co. (Rahway, NJ)
- …staff assigned to a development project as neededLead biostatistics in early or late clinical development planning to ensure that study designs ... and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.Lead the interaction with Clinical , Regulatory, Statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diverse external providers for clinical trials, companion diagnostics trials, clinical development , and regulatory submissions. The position will perform ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP. QSP ... aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead,… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development , the role focuses on LC-MS/MS of small ... , nonclinical and biomarkers studies. This translational role resides within the Clinical Development organization, works closely with colleagues in other… more
