- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Title:** Clinical Development Program Lead , Hematology **Position ... Description:** The Clinical Development Program Leader (CDPL), Hematology sits within Clinical ...overall portfolio view + Provide strategic insights into the clinical development plans + Lead … more
- Bristol Myers Squibb (Princeton, NJ)
- …Responsibilities** + Collaborate with Clinical Science Program Lead and Clinical Development Lead to support development of clinical ... lifecycle planning + Lead implementation of assigned clinical development and/or lifecycle plans + Maintain...Maintain an advanced understanding of all protocols within assigned Program + Provide scientific and clinical leadership… more
- Novo Nordisk (Plainsboro, NJ)
- …KOLs and Principal Investigators. Essential Functions + Support the ALD clinical development program as medical lead and expert drug developer, providing ... the Senior International Medical Director will be the medical lead for clinical development of...Disease department. Work with the Clinical Operations, Non- Clinical Research, Medical Writing, Program Management, CMC… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …(s) for Clinical Data Management (CDM). + Maintains an overview of clinical program (s) status and issues and proactively communicates progress, risks, issues ... The Program Data Management Lead is responsible for...if can:** + Acts as point of contact for clinical program and study level escalation. + Reviews… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Senior Manager Clinical Study Lead ** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned ... large and/or complex clinical trials from study design, through execution, to study...the assigned study + Provides operational input into protocol development + Oversees and provides input to the … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... approved Safety Management Team (SMT) materials + Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs),...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director Clinical Development - Respiratory Date: Dec 17, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 59023 ... people to make a difference with. **The opportunity** Director, Clinical Development is responsible for the ...documents for IND/NDA and other regulatory documents + May lead an NDA submission team independently, as needed +… more
- Bristol Myers Squibb (Princeton, NJ)
- …Read more: careers.bms.com/working-with-us . **Functional Area Description** The Early Development Clinical Scientist function provides scientific expertise ... to clinical scientists on study team (matrix leadership). + May support clinical development planning in collaboration with Early Clinical Development… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Early Clinical Development function is part of a global scientific organization ... trials from Phase 1 through Proof-of-Concept by + Articulating clinical development strategy + Analyzing, interpreting, and...protocols + Strong leadership skills with proven ability to lead and work effectively in a team environment The… more
- Sanofi Group (Bridgewater, NJ)
- **Director** Global Clinical Development Strategy Expert **Location:** Swiftwater, PA, Cambridge, MA, Orlando, FL or Morristown, NJ site (flexibility with US ... on millions of patients around the world. The Director Clinical Development is the clinical /medical/scientific...meetings, communications, CTD submissions) **About you** + You will lead the clinical study team and as… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead (s): + Oversee the execution of studies in ... team to ensure timelines meet the needs of the clinical development plan.o Ensure new team members...are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead (s); serve… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … studies and ensures scientific integrity and interpretation of study data of a clinical development program . The Director leads in a matrix environment ... The Director Clinical Sciences, Hematology, leads in the development...day may include the following:** + May function as lead Clinical Scientist (CS) for program… more
- Bristol Myers Squibb (Princeton, NJ)
- …training Clinical Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops clinical plans and ... work and in their personal lives. Read more: careers.bms.com/working-with-us . **Senior Clinical Trial Physician, (Late Clinical Development , Cell Therapy,… more
- Lilly (Branchburg, NJ)
- …degree + At least 5 years work experience in supply chain management or clinical development **Additional Preferences:** + Experience with SAP + Intermediate to ... will be responsible for driving robust, strategic discussions across Clinical Capability and Clinical Design Development...portfolio analyses through robust data and metrics analysis + Lead and ensure operational excellence in Clinical … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …New Jersey_** **POSITION OVERVIEW:** With considerable independence, you will typically lead clinical pharmacology strategy and clinical pharmacology ... and reporting, and support of regulatory filings. You will typically lead clinical pharmacology cross-functional study sub-teams, which entails coordinating… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …of clinical technologies like eCOA, IRT, EDC, Medical Devices, and Clinical Data Wearhouse for large drug development programs. + Working knowledge ... are met with the highest degree of quality. + Lead study level technology & vendor oversight activities. +...identify new innovative trends in technology to better support clinical trials. + High complexity at program … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …regulatory submissions. + In partnership with functional stakeholders and with Global Development Compliance, they contribute to and may lead within-function and ... using clinical trial systems and technologies. + Contribute to development of new processes and technologies in compliance with quality standards (including… more
- Bristol Myers Squibb (Princeton, NJ)
- …members within the assigned project to execute activities associated with the conduct + May serve as Clinical Trial Lead for one or more trials + May lead or ... clinical research, or equivalent + Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations + Ability to… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …+ Partners with key functions (including Therapeutic Area Units/Business Units, Regional Development Centers, Clinical Operations, Clinical Site Startup & ... Partner Outsourcing management issues, develop contingency plans and escalate to Clinical Partner Outsourcing leadership as necessary. + Lead /co- lead … more
- Vitalief (New Brunswick, NJ)
- …leading site solutions partner focused on improving the value and contribution of clinical trial sites across the drug development lifecycle. We offer integrated ... seeking a strong "hands-on" resource to build out and lead our Clinical Research Consulting team to...novel thinking. + We offer a very competitive compensation program = Base Salary + Bonus + Equity Incentives!… more