- 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 strategic ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the...including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred- Relevant… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution: Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... in? Are you ready to experiment with us? The Position The Integrated TA Lead is instrumental in shaping and executing NNI's strategic initiatives within the TA. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Team Leader , is a senior, cross-functional leader in Daiichi Sankyo's Global R&D ... In this key role, the candidate will have to lead a complex, global team in charge of a...a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing… more
- Insmed Incorporated (Bridgewater, NJ)
- …Associate Director of Biostatistics is responsible for the statistical aspects for complex clinical trial(s) or indication product line . This role leads the ... responsibilities will include, but not necessarily be limited to, the following: Lead complex clinical trials or indication corresponding to one or… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …in appropriate regional, state and national professional health management and clinical associations.In conjunction with Service Line development and offerings, ... health of our communities. About the Role:Job SummaryThe Director of Cardiovascular Clinical Business (the Department) is responsible and accountable for both the … more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …About the Role:Posting DetailsJob SummaryThe Clinical Nurse Specialist (CNS) is the clinical lead for a program or an area of defined nursing practice. ... The CNS oversees clinical practice in a service line /population of...expert clinician. The CNS and Nursing Director collaborate to lead clinical practice and education on the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, ... all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development,...data sets, data structures to ensure delivery is in line with agreed upon EFTs, eDTS, DS External Data… more
- Catalent (San Diego, CA)
- …San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the Site Leadership Team, you will partner with ... development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional… more
- Merck & Co. (Rahway, NJ)
- …(Hematology) will be accountablefor the launch and life cycle management for our in- line assets in Hematology.In this capacity, the candidate will lead all ... will work closely with value and Implementation teams under clinical development -to ensure all clinical trials...teams under clinical development -to ensure all clinical trials include the appropriate design input needed for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies. Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence, effectiveness ... as other research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business… more
- Merck & Co. (Rahway, NJ)
- …multiple diseases and millions of patients on a global scale. -This role will lead an exciting pipeline product currently in Phase 2; a Factor XI anticoagulant being ... the commercial opportunity with key cross-functional stakeholders. Primary Responsibilities: Lead key strategic projects that drive product strategy and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Director of Biostatistics is a highly visible role within the Clinical Development organization and is responsible for the statistical leadership and ... expertise for a product line through the entire development process. This role provides...and leads the statistical design, analysis, and reporting of clinical trials, and interacts with global regulatory agencies. This… more
- Merck & Co. (Rahway, NJ)
- …and implement an effective validation and testing strategy for the platform team, in line with industry best practices and standards. Lead and manage a team of ... Job Description: We are looking for a manager to lead and manage the validation and testing activities for...processes, tools, and techniques, enhancing productivity and quality in line with industry best practices. Education: Bachelor's degree in… more
- Catalent (Philadelphia, PA)
- …room and equipment set up, equipment verification, routine packaging operations, line clearances, room and equipment cleaning activities. The Quality Inspector will ... Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and...your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and… more
- Catalent (San Diego, CA)
- …development, GMP manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit and develop exceptional ... activities including release of GMP materials, shipment verification and performance of line clearances in a Class 100,000 environment, maintenance of clinical … more
- Insmed Incorporated (Bridgewater, NJ)
- …The Director of Field Medical Excellence will establish and lead worldwide Field Medical Excellence Forums.ResponsibilitiesField Medical Strategy - Develop ... Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop consistent… 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 ... is able to provide clear direction on Medical Affiars engagement needs to the clinical data science & evidence team and other relevant functions As a senior level… more
- Catalent (San Diego, CA)
- …including protocols, test methods, master batch records, and specifications for analytical testing. Lead role in onboarding new compounds to the site involving review ... a new compound are considered against site capabilities.Perform internal and external audits. Lead or support client audits along with the Director and Associate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operations with a focus on operational excellence in support of patient needs Lead design, implementation and ongoing management of all Rare Disease patient HUB ... and communication of best practices Coordinates agency training in line with business objectives and with input where appropriate...the annual brand planning process with data driven insights Lead and execute ongoing analyses of the market in… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall ... the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory submission documents (eg, IBs,… more
