- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThis position supports early phase oncology development and leads complex studies in ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… 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)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role ... the company in outside groups.Contribute to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or PharmD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Merck & Co. (Rahway, NJ)
- … processes for human health while ensuring a phase appropriate approach during early development .In this role, the person will be responsible for the ... for oral products.- This research-based team contributes to Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverables, which is the development of robust… more
- Merck & Co. (North Wales, PA)
- …project management experience at or supporting -pharmaceutical/biotech companies related to the clinical development processAt least 2 years of experience in ... current publication policies and industry trends.Responsibilities:With oversight from the Director Lead, lead development of and maintain...publication managementUnderstanding of the clinical development process andclinical study data for… 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
- Merck & Co. (Rahway, NJ)
- …ForEvaluating pre- clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug ... Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… more
- Merck & Co. (Rahway, NJ)
- …that help everyone to be more productive and enable innovation.The Research and Development Sciences (RaDS) value team in Our Company's R&D IT brings together ... technology products and associated services to advance the drug discovery and development pipeline.We are seeking a Senior Information Architect with expertise in… 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
- Merck & Co. (North Wales, PA)
- …according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation ... DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects… more
- Merck & Co. (North Wales, PA)
- …record of contribution to medical affairs strategiesExperience in country/region medical affairs or clinical development (in IBD or SLE or SSc Vitiligo and ... from key countries and regionsServes as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label)… 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 ... Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… more
- Catalent (Philadelphia, PA)
- …pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function...leadership and Quality Management support within each of the Clinical development supply division. This individual will… more
- Eisai, Inc (Exton, PA)
- …pre-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct impact on ... and oncology, with a strong emphasis on research and development . Our history includes the development of...as a scientific and technical resource to support several early to late stage manufacturing programs.This position will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and4 or More Years More than 5 years of experience in imaging operations in oncology clinical development of both early and late phase clinical trials, ... as other research areas centered around rare diseases and immune disorders. SummaryThe Director of Oncology Imaging Science and Oversight will be a member of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials preferred- Knowledge of all phases of drug development , including early and late phase clinical development and submission preferred- Solid ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research and Precision Medicine. ... and Pharmacovigilance (CSPV) must be embedded in R&D as early as possible. This led us to create the...candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with… more
- Catalent (Harman, WV)
- …pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... Position Summary The Director , Quality Systems is responsible for the management...substance and/or final drug product to support Phase I/II clinical trialsWork with clients during initial and subsequent manufacturing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... About the Department Our East Coast Global Development Hub brings together the best minds in...internal stakeholders Perform or supervise regulatory review of all clinical and nonclinical documents for submissions, eg, clinical… more
