- Merck (Rahway, NJ)
- …Acting as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with ... Global Clinical Trial Operations (GCTO), and Global Clinical Development (GCD) leaders,...and understanding of end-to-end drug development and clinical trial processes, including related standards and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …- Guide the Clinical Science staff in the creation of the development strategy ensuring the highest scientific/medical standards in accordance with ethical ... organizations, co- development partners, and strategic outsourcing. - Contribute to Clinical (oncology) Development initiatives, global education and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures efficient ... vision, direction and future investments. **Responsibilities** - Oversees bioanalysis strategy from global development and global regulatory perspectives -… more
- Rockefeller University (New York, NY)
- …and carrying out clinical research study activities accomplished through the development or updating of protocols, procedures, and standards for a study ... the following: + Coordinate, facilitate, and carry out assigned clinical research study activities through the development ...assigned clinical research study activities through the development or updating of protocols and standards … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be ... not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global ...Clinical Science staff in the creation of the development strategy ensuring the highest scientific/medical standards … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle. + ... disabilities. **Summary** The Associate Director, Clinical Data Standards , is responsible for the development , maintenance,... standards framework. + Define, manage, and govern clinical data standards ; Global Libraries,… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Senior Director, Clinical Development & Medical Affairs (CDMA) Requisition JR000014103 Senior Director, Clinical Development & Medical Affairs ... - USA501 Additional Locations Bridgewater, NJ Job Description The Senior Director, Clinical Development Medical Affairs (CDMA) drives strategy and accountability… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the ... in the strategic planning for future change. Subject matter expert on global clinical trial registration, result posting, plain language summary, redaction… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or ... of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …degree required. + 6-9 years of experience with a bachelor's degree required. + Clinical development or post-marketing experience to be able to apprehend safety ... other clinical study documents + Authors or oversees the development of safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and immune disorders. **Summary** This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This ... clinical study safety reporting and activities. + Global Clinical Study Start-Up Documentation: Reviews all...more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred Daiichi Sankyo, Inc. is… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development , sales, marketing, medical affairs, and business ... Director, Clinical Operations will be responsible for clinical development strategy, clinical program...standards and metrics for the execution of all clinical trials and related activities. **Qualifications** + Bachelor's Degree… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …outcomes (PROs), ensuring the payer perspective is incorporated in the assigned clinical development programs and the evidence needed to support optimal ... role will contribute with HEOR sections in target product profiles (TPPs), product development plans, clinical development plans, and commercialization plans… more
- Merck (Rahway, NJ)
- …job aids/SOPs and participates in or leads cross-functional teams to develop global clinical development procedures. Identifies and communicates best ... Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development . Represents Early Stage Development on early… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Pfizer (New York, NY)
- …within the Global Biometrics and Data Management (GBDM) organization, the Clinical Data Scientist (CDS) is responsible for timely and high quality data ... to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose...to collect, review, monitor, and ensure the integrity of clinical data, applies standards , data review and… more
- Merck (Rahway, NJ)
- **Job Description** Clinical Development heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards , Trial ... first site ready. + Remove obstacles and enable the Global Clinical Trial Organization to focus on...Organization to focus on what matters. As Research and Development IT continues the transition from project / portfolio-based… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- J&J Family of Companies (Raritan, NJ)
- …be a member of the Global Medical Affairs team, leading the conduct of a global clinical study using the portfolio of compounds at Janssen with the aim of ... clinical research and the highest personal and ethical standards . Experience in running and the conduct of global or highly complex studies is a key area of… more
- Pfizer (New York, NY)
- …excellence, and the highest ethical standards . He or she will lead clinical development strategy and program execution of research projects with a particular ... be responsible for creating the overarching strategy for early clinical development programs with a focus on...addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0%… more