- Daiichi Sankyo, Inc. (Bernards, 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. (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
- Eisai, Inc (Philadelphia, PA)
- …a difference. If this is your profile, we want to hear from you. The Associate Director / Director , MSLs is responsible for the leadership, direction and ... management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... & Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design… more
- Merck & Co. (North Wales, PA)
- …regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Executive Director / Associate Vice ... all phases of clinical development (pre- clinical to post-licensure). The Senior Director will... Director will manage the entire cycle of clinical development , including study design, placement, monitoring,… more
- Merck & Co. (Rahway, NJ)
- …of our Company's drug product pipeline.- The FLEx Sterile Process Engineer at the Associate Director level serves as a technical subject matter expert in process ... and Analytical will be required to ensure effective process development in support of clinical development .- -The successful candidate will drive continuous… more
- Merck & Co. (North Wales, PA)
- … Director , or Director level personnel responsible for oncology clinical development programs or projects. Work closely with a cross-functional group ... Vice President will manage and oversee the entire cycle of clinical development , including study design, initiation, execution, monitoring, analysis, regulatory… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the ... the development of new compounds The Senior Clinical Director may: Oversee the Clinical...affairs, statistics, and manufacturing to manage clinical development projects; and assist the Associate Vice-President/Vice-President… more
- Merck & Co. (North Wales, PA)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you.The Northeast Region covers NJ, PA, & DE.The Associate Director , Regional Thought Leader Liaison (RTLL), AD Marketing will lead and ... through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Professional Services is a field-based position responsible for hiring, leading, coaching and motivating a team of ... goals of the companion animal business through medical education and business acumen. The Associate Director partners with peer leaders to develop and execute a… 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)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... objectives and minimize regulatory risk-Provide regulatory consultation in the development and implementation of US marketing strategy and promotional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and...within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy. Interacts frequently in ... tactical execution Leads pricing and contracting strategy, playbook, and guideline development for all new product launches within responsible therapeutic area, with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Strategic Planning provides strategic insights ... are tracked and ensure implications are assessed and communicated on timely manner- Clinical Development Life Cycle Management Decision Support: Be the key point… 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 ... About the Department Our East Coast Global Development Hub brings together the best minds in...functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data Management, ... areas centered around rare diseases and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the… more