- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate group within ... departments within the Company. Also communicates with outside consultants (ie CRO 's) as needed. Qualifications: Successful candidates will be able to meet… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory ... to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents supporting CDx… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical trial experience within a pharmaceutical, biotechnology, or CRO required, Training & Development or Operations experience preferred Three (3) ... conduct of clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR),… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful ... all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead… more
- Amgen (Washington, DC)
- …patients worldwide. It's time for a career you can be proud of. **Medical Director , Global Medical Affairs Lead, Obesity - US, Remote** **Live** **What you ... allocation of resources **Preferred Qualifications:** + 3 years of clinical research and/or medical affairs experience in...or board eligible + Minimum 5 years of Medical Affairs experience in industry (biotech, pharmaceutical or CRO… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate group within ... departments within the Company. Also communicates with outside consultants (ie CRO 's) as needed. **Qualifications:** Successful candidates will be able to meet… more
- Actalent (Paramus, NJ)
- MUST BE ON-SITE IN PARAMUS, NJ 5 DAYS/WEEK The Associate Director , Clinical Operations is responsible for oversight of US clinical development providing ... trial implementation, execution, and outcome, building consensus within the global clinical operations team. The Associate Director is also responsible for… more
- BeiGene (Emeryville, CA)
- The Associate Director (AD) Clinical Study Management leads both indirect and direct reports, external partners, consultants, vendors and external budget to ... area peers including Drug Safety, Quality Assurance and Regulatory Affairs , as well as thought leaders in order to...sourcing when needed to ensure that external partnerships (eg CRO ) are effectively supporting clinical trials, within… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …best of my knowledge. **Job Description** **Job Description for Senior Medical Director , Clinical Science, Marketed Products Development** As the Senior Medical ... Director Marketed Products (SMDMP) you will report to the...MD or internationally recognized equivalent plus 8 years of clinical research experience in the pharmaceutical industry, CRO… more
- ThermoFisher Scientific (Morrisville, NC)
- …helping find cures for cancer. **How will you make an impact?** The **Sr. Director , Procurement - Clinical Research Group (CRG)** is the global leader ... Solutions (IVRS, EDC, ePRO etc.) centralized services, patient services, home nursing, clinical ancillary materials and specialty CRO services. + Commercial… more
- Boehringer Ingelheim (Ridgefield, CT)
- …expected to work from the Ridgefield, Connecticut office 2-3 times per week. The Director , Clinical Contracting & Budgets will support the Executive Director ... of resources and coordination of all staffing decisions. The Director , Clinical Contracting & Budgets supports the...Site Feasibility and Patient R&R, Legal, Ethics & Compliance, Clinical Development & Medical Affairs (CDMA), Translational… more
- BeiGene (Emeryville, CA)
- …scientific or healthcare discipline and 12+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Preferably ... a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. All qualified… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Director , Clinical Development (Gene Therapy Program) Job Profile Title Director ... metabolic, and infectious disease. We are currently seeking a Clinical Development Director to be responsible for...operations on the trial execution strategy as well as CRO , site, and vendor selection. You will also provide… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. ** Clinical Research Medical Director - Cardiovascular, US - Remote** **Live** **What you ... the world. The Cardiovascular/Metabolic Therapeutic Area is seeking a Clinical Research Medical Director to play a...CRO company) + Five or more years of clinical research experience and/or basic science research combined with… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. ** Clinical Research Medical Director , Inflammation, US - Remote** **Live** **What you ... world. In this vital role you will serve as clinical expert to provide clinical /scientific knowledge into...content input to materials to be used in Scientific Affairs as well as the Commercial Organization + Approximate… more
- Amgen (Washington, DC)
- …patients worldwide. It's time for a career you can be proud of. ** Clinical Research Medical Director , Rare Disease, Late Development, US-Remote** **Live** **What ... In this vital role you will contribute to all clinical development executional activities involved in currently running Phase...content input to materials to be used in Scientific Affairs as well as the Commercial Organization + Approximate… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Clinical Research Medical Director ** **Live** **What you will do** Let's do this. ... world. In this vital role you will serve as clinical expert to provide clinical /scientific knowledge into...content input to materials to be used in Scientific Affairs as well as the Commercial Organization + Approximate… more
- University of Miami (Miami, FL)
- …tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The Executive Director , Legal, Regulatory and UHealth Risk Management ... related legal and regulatory issues related to the UHealth clinical enterprise. Reporting directly to the UHealth Chief Risk...the general oversight of the UHealth Chief Risk Officer ( CRO ) and acts in the CRO 's absence… more