- 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
- 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
- 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)
- …primary responsibilities of this position are the plan, design, and conductance of early development clinical studies; the preparation of regulatory ... and report studies; and the representation of the specialty medicine (SM) clinical development (CD) function on study and project teams. This position requires… 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 ... Our Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… 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. (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. (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)
- …The GPAM Associate Director , Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams, partnering with ... Advanced degree (eg, MS, MBA, Ph.D., PharmD) preferredExperience and knowledge of clinical drug development strongly preferred; including the different phases of… 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Marketing Women's Cancers Associate Director is a vital role that will be responsible for shaping Women's Cancers indications across ... early stage and advanced settings. You will play a...the Commercial Excellence Framework (L3 Next) and associated strategic development in close collaboration with the Global Disease Lead.Lead… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play ... Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launch- Leads CDx Partner evaluation and selection,… more
