- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall ... study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...make a difference? The Position The Therapy Area (TA) head is accountable for setting an integrated medical affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliance with evolving global regulatory requirements and with company objectives. The Head of GRA Global Labeling leads a team of labeling strategists, ... deviations in all markets. This role is accountable for effective and efficient global processes for labeling development and review, and resourcing that… more
- Merck & Co. (Boston, MA)
- …extensive network of key cross-functional partners both within TMed, Discovery Research, and Global Clinical Development .-The candidate will be expected to ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development .-The AVP provides strategic oversight for the early… more
- Catalent (Harman, WV)
- …array of categoriesCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over ... Position SummaryThe Head of Quality-Maryland is responsible for setting the...of all sizes to advance new medicines from early development to clinical trials and to the… more
- Merck & Co. (Rahway, NJ)
- …the goals,-purpose and mission of our Research & Development Division , Global Clinical Development (GCD) and GCTO.Ability to identify problems, ... Operations.Collaborates internally with HQ functions, regional and local operations, EU Clinical Development , Pharmacovigilance, Regulatory Affairs, Global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... for the broader GPM&L organization. Ensures Project Team awareness of the Global Development ProcessesActively contributes to progressing the GPM&L department as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Brand Team, and Global Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic discussions. ... into the Global Oncology Medical Affairs Franchise Head .Responsibilities-Responsible for the development of the ...and enable the team to act.Provides medical leadership toGMA clinical operations teams as part of evidence generation forums… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …impacting the respective clinical programs.Help to ensure in collaboration with Global Development Operations (GDO) ( Global Clinical Operations ... strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head...and in global teams.Strong Industry Network in clinical development . Knowledge and understanding of cultural… more
- Merck & Co. (Rahway, NJ)
- … Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and ... effective, innovative medicine.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...are not limited to:Ownership of country and site budgets. Development , negotiation and completion of Clinical Trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the responsibility of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior ... successful execution of all operational components of a large-scale global clinical program using strong clinical...the associated budget meet the needs of the overall development plan agreed to by the Global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Brand Team, and Global Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic discussions. ... into the Global Oncology Medical Affairs Franchise Head .Responsibilities- Responsible for the development of the...enable the team to act.Provides medical leadership to- GMA clinical operations teams as part of evidence generation forums… more
- Daiichi Sankyo, Inc. (Munich, ND)
- … global oncology early development studies, functional lines including, global regulatory operations, biostatics, data management, clinical science and ... accomplish its mission to create an innovative and robust global network, to execute oncology early development ...series, topic and portfolio KEE meetings.Working with the OEDC head to evaluate sites and recommend course corrections.Being a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and executing project activities Understands high level import/export requirements for global distribution of clinical ancillary materials and ensures the ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as a Novo Nordisk representative in interactions with Health Authority Inspector(s) at clinical trial sites Support local/ global quality projects to improve the ... 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)
- …for supporting the Global R&D organization and will partner with the Head of Resource Management to drive the establishment of expert capacity planning and ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...team, this position will be responsible for driving the development and implementation of the project and non-project FTE… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …tactics and market shaping initiatives including but not limited to KOL development , advisory boards, clinical communications and medical education programs ... member of Mature Business Unit Leadership Team responsible for directing the development and execution of the commercial marketing strategy, inclusive of payer… more
- Novo Nordisk Inc. (Chicago, IL)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development , CMC, and program management to drive the ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular Mechanisms. In this role,… more
- Novo Nordisk Inc. (Boulder, CO)
- …discovery, CMC, and development teams. Relationships This position reports to the Head of IP and Legal, US R&D. The role requires a proactive, dynamic, ... a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi… more
