- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building for the future, creating a distinct ... clinical trials within several key assets across our development portfolio. You will become part of the ...development portfolio. You will become part of the Clinical Operation Leadership team reporting to the Vice President… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities.Summary, Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …teams on all aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and ... Position SummaryThe Sr. Director of Technical Transfer is responsible for activities...functional teams.Plan, direct and monitor tasks related to process development , scale-up, process optimization, customer technology transfer activities with… more
- Merck & Co. (Rahway, NJ)
- …Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire ... commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position Supports the North America Clinical Development (NACD) Clinical Research Equity (CRE) strategy integrating ... inclusion in our clinical portfolio. Relationship This role reports into the Director of Clinical Research Equity supporting the strategy across NACD. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Merck & Co. (Rahway, NJ)
- …Involved in research activities for innovative statistical methods and applications in clinical trial development . Education and Minimum Requirement: PhD or ... in statistical research activities and in application of novel methods to clinical trial development . Preferred Skills and Experience :Publications in peer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA ... in patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will… more
- Merck & Co. (Rahway, NJ)
- …time to approval by global regulatory agencies.Reports to Associate Vice President, Executive Director , or Senior Director in the General Medicine ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with... experienceM.D. with minimum of 3 years relevant drug development experience or clinical experiencePhD/PharmD with minimum… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product ... pipeline.The Director will report to the Executive Director of Sterile Product Development - Mixed... with exposure to all stages and aspects of development (preclinical, clinical , and commercial) and cGMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area ... requirements/precedence.Represent Daiichi Sankyo's regulatory group in internal and external development project meetings. Provide guidance to peers and cross-functional… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will...key decisions for programs across all phases of drug development . The complexity and scale of data being generated… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Scientific Affairs (EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic ... community to positively impact Research and Development (R&D) strategy for new medicines and to improve...Company's global scientific input forums to gain external scientific/ clinical insights in support of our Company's R&D strategySustains… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... objectives and minimize regulatory risk-Provide regulatory consultation in the development and implementation of US marketing strategy and promotional… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: End-to-End Technical Product Leadership:- Development and Commercialization Team (DCT) Leader Role in Small Molecule Global Science, ... Engineering, & Commercialization (SM GSEC) The Director , DCT Leadership position in the Manufacturing Division is...responsibilities, as it entails guiding drug product candidates from development to launch in line with enterprise priorities.- As… more
- Merck & Co. (Rahway, NJ)
- …and reimbursement. The incumbent is expected to work cross-functionally with clinical development , medical affairs, biostatistics, market access, commercial and ... improve patient health outcomes. Under -the guidance of a senior leader, the Executive Director will be...our Company's products. -Develop a strong matrix relationship with clinical development , BARDS (Biostatistics and Research Decision… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of strategic ... Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior ...for select clinical trials, in collaboration with Clinical Director and Clinical Operations… more
