- Merck & Co. (Rahway, NJ)
- …collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality ... Therapy Areas, and when appropriate, Human Health colleagues. Contribute to the program life-cycle management through effective study allocation and execution… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership ... diseases and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and other key… more
- Merck & Co. (Rahway, NJ)
- …designed clinical trials is critical to drug development.The Associate Director , Clinical Trials Communications role within our Research & Development ... role in a fast-paced matrixed environment. Preferred Experience & Skills: Clinical trial communications experience Budget and agency management experience.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …balances and (ii) a state of inspection readiness throughout the life of the clinical program & study.Establish, maintain and provide training and guidance to ... around rare diseases and immune disorders. SummaryThe Site Contracts and Budgets Management (SCBM) group, in Global Clinical Operations (GCO), develops strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic ... partnering with the Global Team leader as the Project Management lead on drug development projects. This position can...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)
- …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people ... implementation of studies. Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working ... This opportunity will require a focus on all the clinical aspects of the upcoming HS program ....knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access departments as needed Project management liaison: Assist in developing clinical program time lines, budgets, and strategies Other essentials: Must ... in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Insmed Incorporated (Bridgewater, NJ)
- …project teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to ... management regarding the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory… more
- Insmed Incorporated (Bridgewater, NJ)
- …addition, the ED will be responsible globally for executing the safety and risk management activities for one or more clinical development or marketed products ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team.… more
- Merck & Co. (Rahway, NJ)
- …Standards Working closely with the Global Clinical Data Standards (GCDS) Sr. Director of Operations and Reference Data Management within the Global Data ... provide insights into implementation of strategic direction.In support of the Senior Director , Operations and Reference Data Management , ensures project delivery… more
- Merck & Co. (Rahway, NJ)
- …therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based in ... 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)
- …Leads CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development ... and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory… more
- Eisai, Inc (Nutley, NJ)
- …and Clinical Operations. Essential Functions Work with key stakeholders, management , and functional area leads to develop strategic and aligned Medical Affairs ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic ... this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management ,… more
