- Merck & Co. (Upper Gwynedd, PA)
- …with proven track record of contribution to medical or clinical development strategiesCustomer expertise, especially of scientific leadership and other key ... Job DescriptionThe Executive Director , Global Medical and Scientific Affairs...Brand and V&I Outcome Research Team leads to define clinical development plans and brand strategies for… more
- Merck & Co. (Boston, MA)
- …and ultimately save and improve patient lives. Key responsibilities will include: Scientific Innovation: Lead the development and implementation of effective ... and problem-solving skills, as well as the ability to translate scientific needs into actionable plans for implementing data workflows and infrastructure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Guide the Clinical Science staff in the creation of the development strategy ensuring the highest scientific /medical standards in accordance with ethical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical...will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and… more
- Merck & Co. (Rahway, NJ)
- …of clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direcUindirect team members ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will collaborate with… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Clinical Director will manage the entire ... in internal and joint internal/external research project teams relevant to the development of new compoundsThe Clinical Director may:Work closely… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major scientific /medical contributor; For large or complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... possibly as Global Clinical Lead. Responsibilities:Study Strategy: Clinical study leader (CSL) or major scientific /medical contributor; For large or complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... science and technology. With more than 120 years of scientific expertise and a presence in more than 20...of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically… more
- Merck & Co. (North Wales, PA)
- …Asset team. Our Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive Director… more
- Merck & Co. (Rahway, NJ)
- …(GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes defining and optimizing ... functions such as our company's QA, GCD Standards, and Learning & Development . This collaboration is essential in developing and executing strategies that support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... medical guidance for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global … more
- Merck & Co. (Rahway, NJ)
- …potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual...members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within legal and ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and impact to key stakeholders. He or she will aid in the construction of clinical development plans, clinical protocols, and in submission of certain ... goals and enumerate key translational hypothesis that will drive scientific decision-making both from non- clinical and ...data analysis plans, and aid in the construction of clinical development plans, clinical protocols,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics).Responsibilities:Write critical, complex ... science and technology. With more than 120 years of scientific expertise and a presence in more than 20...rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US and Global Brand Team, and US Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic discussions. ... science and technology. With more than 100 years of scientific expertise and a presence in more than 20...compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical… more
- Merck & Co. (Rahway, NJ)
- …driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report ... development with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong influencing and communication… more
