- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that includes veterans and people with disabilities.Summary Reporting to the Disease Area Strategy Team (DAST) Lead for GYN Cancer, this position is integral ... the DAST Lead to build and execute a disease area strategy across the ADC portfolio plus emerging pipeline...critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and respective team members to ensure robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...(PharmD, PhD, MD, DO or equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …lead on drug development projects. This position can be assigned to any therapeutic area and work on projects at any stage of development.As a member of the ... initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... Experience in collaboration with US Oncology Franchise Head oncology therapeutic area is required Qualifications: Successful candidates will be able to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... As a core or extended member of the Disease Area Strategy Team (DAST), the CS Group Leader will...mid-to-late-stage asset protocols Core or extended member on Disease Area Strategy Teams (DAST), including lung, breast and emerging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs, Evidence Generation role is responsible for ... across all relevant functions and aligns with the Disease Area Strategy.- Communicate progress to relevant internal stakeholders using...Leads responsible for other compounds within the same Disease Area and with the Disease Area Strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role is responsible ... across all relevant functions and aligns with the Disease Area Strategy. Ensure alignment of the gap assessment, gap...Leads responsible for other compounds within the same Disease Area and with the Disease Area Strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... PhysicianMaintain up-to-date knowledge of all-important advances within a disease area through scientific literature, critical meetings, and relationships with Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... Physician- Maintain up-to-date knowledge of all-important advances within a disease area through scientific literature, critical meetings, and relationships with Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(IMPD/IND) Responsible to design the audit framework globally for Research area , specifically GLP/GCLP studies.Partners with Audit and Compliance QA function to ... to monitor and provide proper QA oversight of research area , in close collaboration with stakeholders. Ensure metrics for...establishment of the Quality Systems for the Research Quality area , and that all components of QMS are in… more
- Merck & Co. (Rahway, NJ)
- …with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated environment.Master's Degree ... 8 years of industry experience including a regulatory and/or compliance area and experience with technical systems in a regulated environment.Required… more
- Merck & Co. (Rahway, NJ)
- … area of responsibility.To accomplish these goals, the Clinical Director may:Author detailed development documents, presentations, budgets, and position papers ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning...of knowledge by:Maintaining awareness of scientific developments within one's area of expertise, in terms of new scientific findings,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology area preferred TravelAbility to travel up to 30% Global and domestic travel. ... International collaboration and communication (face to face, electronic and tele/video conferencing) across all global time zones required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Financial Forecasting: Develop deep knowledge of the competitive landscape of the brand therapeutic area . Work closely with the Brand team to be aware of the trends ... and evolving dynamics and identify future events. Work with market research team to gather and interpret primary research and secondary analysis to assess effect of market events. Work with market access and contract analytics teams to understand the dynamics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives. This position serves as the primary ... direct/indirect reports. This position also interacts with other therapeutic area leaders and joint Alliance partners.ResponsibilitiesLead a multidisciplinary Global… more
- Merck & Co. (Rahway, NJ)
- …to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide ... to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their… more
- Merck & Co. (Rahway, NJ)
- …world.Looking for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for development and implementation ... regulatory strategy for their assigned projects in the General Medicine therapeutic area . The individual functions with a high degree of independence and provides… more
