- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for ... for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Executive Director, Global Clinical Operations Study Management Group Head has leadership ... and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head 's primary objectives will ... (PDTs) and collaborating with Section Heads, PDT Leaders, and Clinical Directors responsible for the design and medical monitoring...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head , Immunology Translational Medicine, will be responsible for leading the Translational ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early … more
- Merck & Co. (Rahway, NJ)
- …produce safe, effective, innovative medicine.We are seeking a Growth and Improvement minded Clinical Operations Manager - Regulatory that can help drive our ... are a Competitive Advantage for UsSummary, Focus and PurposeThe Clinical Operations Manager - Regulatory is accountable...and externally. Under the oversight of the Senior COM, Head COMs or CRD, the person is responsible for,… more
- Catalent (Harman, WV)
- Position SummaryThe Head of Quality-Maryland is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems ... management review, and building a Patient First culture at the site. The Head of Quality-Maryland is responsible for Quality, Validation and Quality Control and is… more
- Merck & Co. (Rahway, NJ)
- …quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance team push the boundaries of global ... healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and...effective, innovative medicine.Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …positioning it as a strategic partner for key stakeholders including Clinical Development and Regulatory Strategy teams, to create scientific documents supporting ... and mission of the Regulatory Writing function. Serves as the global head of Regulatory Writing and represents Regulatory Writing both globally and regionally… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with ... technology, and with change management skills. Relationships Reports into North American Clinical Development (NACD) Therapy Area Head . Establish and manage… 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 role consistency. Accountability for quality and performance related managing clinical trial sites (ie data quality, document handling, and trial product… 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, labeling ... operations , and compliance specialists located across the US, EU...relationships (including global and regional leaders from Supply Chain, Clinical Safety Pharmacovigilance, Commercial, Medical Affairs and Legal) to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Global Development organization this is a key new role to lead the Clinical Operations function across our Boston, MA and Princeton, NJ campuses through ... both direct leadership of the core Clinical Operations function, as well as ensuring...and due diligence teams Is a member of the Head Quarter Trial Management Council (HQTM Council) Is sponsor/Steering… more
- Merck & Co. (Rahway, NJ)
- …site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands ... the territory for clinical research, finding and developing new-sites. Participates in internal...Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.Works in partnership internally with… more
- Merck & Co. (North Wales, PA)
- …more aspects of our development programs. This position will work closely with the Head of Clinical Imaging and Pathology, Pathology Leads, and other Clinical ... clinical trials for evaluation of efficacy and safetySkill in authoring clinical pathology operations documents for trials using pathology for evaluation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the respective clinical programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical ... strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head...new technologies.Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections,… more
- Daiichi Sankyo, Inc. (Munich, ND)
- …functional lines including, global regulatory operations , biostatics, data management, clinical science and clinical operations . The Network Lead ... required.Experience in assessing potential new FIH sites and in FIH site clinical operations methods required.Experience in site selection for network membership… more
- Aequor (Thousand Oaks, CA)
- …a dynamic production environment at the Thousand Oaks Site supporting development, clinical , and launch activities. Under general supervision, employee will perform ... operations in the Manufacturing area. Operations will...functions on the production floor: bending, reaching above the head , climbing, kneeling, squatting, stooping, walking upstairs, and standing… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations /CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder,...and development teams. Relationships This position reports to the Head of IP and Legal, US R&D. The role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …up, model the way and enable the team to act.Provides medical leadership to- GMA clinical operations teams as part of evidence generation forums and study teams ... and will report into the Global Oncology Medical Affairs Franchise Head .Responsibilities- Responsible for the development of the Global Medical Affairs strategy… more
- Merck & Co. (Rahway, NJ)
- …Director, as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS CMC), will also manage ... team responsible for a group of products and includes pre-approval regulatory work ( clinical and marketing applications such as IND, CTA, NDA, and MAA) and… more
