- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development , Respiratory will focus on driving strategy, development , and ... new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be responsible for… more
- Tris Pharma (Monmouth Junction, NJ)
- …NJ facility for an experienced MD to serve as Senior Director or Director, Clinical Development . Title and salary commensurate with experience. The position is a ... core member of the Clinical Development management team responsible for developing and implementing, in alignment with corporate strategy, the clinical … more
- Merck & Co. (North Wales, PA)
- Job DescriptionActing as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with ... Improvement (QCI), Global Clinical Trial Operations (GCTO), and Global Clinical Development (GCD) leaders, and internal stakeholders (eg Global Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. SummaryThe Associate Director, Global Oncology Clinical Development (GOCD) Functional Excellence supports the ... Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical development activities, and innovations in addition to amending… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mid-term, long-term). These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategy. Responsibilities - Accountable for developing… more
- Merck & Co. (North Wales, PA)
- …or marketed Oncology medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will ... manage the entire cycle of clinical development , including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Evaluating pre-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team (data management, clinical operation and other functions) to implement clinical development plan: study ideation, protocol development , review case ... Guide the Clinical Science staff in the creation of the development strategy ensuring the highest scientific/medical standards in accordance with ethical and… more
- Merck & Co. (Rahway, NJ)
- …opportunities within and beyond CSSM Exposure to Senior level positions within the clinical development forum Hands-on experience in the conduct and execution of ... stakeholders (eg, country operations, committees, vendors) in support of clinical study objectives. - Support development of...support of clinical study objectives. - Support development of site and CRA training materials - Prepare… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Head of Clinical Trial (CT) Diversity sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... are inclusive and representative of diverse patient populations- Collaborate with Oncology Clinical Development Global Clinical Leads to ensure appropriate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by external partners such as CROs. Exceptions must be discussed with clinical development .Review, approve and/or drive related process related improvement to ... and Infrastructure.Build processes withing GCO to achieve diversity in clinical trials and patient focused drug development ...in clinical trials and patient focused drug development (ie. Patient voice) that are effective, streamlined and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documentsAuthors or oversees the development of safety sections… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …college or university)Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience required Experience Qualifications:1 or More ... Work with supervisor to provide input into individual career development plan.Assist in planning and execution of clinical... development plan.Assist in planning and execution of clinical studies, under the close supervision of a Manager… more
- Merck & Co. (Rahway, NJ)
- …beyond Clinical Trial Operations Exposure to Senior level positions within the clinical development Hands-on experience in the conduct and execution of ... clinical trials- Development of data management, data analysis, critical thinking and leadership skills Work Experience Experience/Skills We are Looking for: -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... industry, regulatory agency or academia, with exposure to drug development , clinical pharmacology, and/or epidemiology requiredDaiichi Sankyo, Inc.… more
- Novo Nordisk Inc. (WA)
- …site management activities. Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or university)- Bachelor's Degree (preferred in Life Sciences) with relevant clinical development experience requiredExperience Qualifications- 2 or More Years ... around rare diseases and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a comprehensive interface for risk and issue management with strategic development partners.Close partnership with clinical quality management and other ... clinical trial execution in one or more key functions (eg clinical research & development , clinical science, clinical quality assurance, project… more
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