- Pfizer (New York, NY)
- **ROLE SUMMARY** The Global Development Lead will be responsible for defining and executing on the development strategy of two assets at different ... programs, cross-functional collaboration, and represent program(s) externally. **ROLE RESPONSIBILITIES** + Lead product specific Global Development Teams +… more
- Bristol Myers Squibb (Madison, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Position: VP, Global Program Lead - Hematology Development ** ** Global ... Program Lead Role Summary:** The VP - Global Program Leader (GPL) in Hematology Development ...agility in prioritizing and navigating competing demands + For late development projects, prior submission experience is… more
- Bristol Myers Squibb (Madison, NJ)
- …(GPL) and the Senior Project Manager (GPM) to lead sub-GPTs of the Global Program Team (GPT) and drive the development of integrated, efficient, and ... is looking for a Director Project Manager (PM) to lead indication focused Sub-GPTs of the KarXT Global...decisions for the broader portfolio value. + **Director, PM ( Late Development )** + At the director level,… more
- Pfizer (New York, NY)
- …the study team in governance meetings and submissions, partners with/supports the Development lead /Medical Director regarding study and disease area strategy. + ... and quality of clinical trial(s) in support of the development strategy for programs within the Late -Stage...ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations. + Demonstrates a passion for helping patients… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Regulatory Operations to ensure e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned clinical program. ... pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines… more
- Pfizer (New York, NY)
- …precision medicine, complemented by an extensive pipeline of over 50 programs in clinical development . + The Medical Strategy Program Lead will report to the ... Medical projects or sub-projects under the general direction of their respective Oncology Global Medical Lead . This will be in partnership with other Medical… more
- Sanofi Group (Morristown, NJ)
- **Director** Global Clinical Development Strategy Expert **Location:** Swiftwater, PA, Cambridge, MA, Orlando, FL or Morristown, NJ site (flexibility with US ... site) **About the job** We are an innovative global healthcare company that helps the world stay ahead...exposure to diverse array of programs in early and late -stage development or more experience conducting early… more
- Merck (Rahway, NJ)
- …with functional experts across the enterprise to ensure operational excellence in the late development of assets within the Respiratory Section of Global ... **Job Description** The Associate Vice President (AVP)/Section Head, Global Clinical Development , Respiratory will focus...the organization therefore requiring someone who has built and lead clinical development plans from the ground… more
- Organon & Co. (Jersey City, NJ)
- …can be 100% remote in the US** The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the ... development assets within the Organon portfolio. The TMED Lead also will be responsible for the rationale, study...on the EDP (TMED scope: first-in-man to Phase 2a), late -stage development plans or, for mature or… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …teams. The project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC ... Lead on complex and/or late -stage project or act as main CMC ...or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s),… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or ... Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects...or resources, may assist another Global Labeling Lead by managing labeling development or approval… more
- Merck (Rahway, NJ)
- …manufacturing, medical affairs, Outcomes Research and Access. + Understanding of Drug Development Process (Early and Late Stage). + Strategic Thinking: Proven ... It is an exciting time to join our company's Global Cardiometabolic & Respiratory Team, as we build an...this role. **Specific Job Tasks Include:** + Support the development of a Scientific Leader engagement strategy that optimizes… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …is required such that interaction and contribution across the spectrum of Discovery through late state development is achieved. + Identify and align all of the ... The Global Program Head (GPH) for Oncology drives the...for several REGN's oncology antibody program(s) forward from the lead selection through BLA application. This role has a… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late -Stage Development Portfolio. The individual will play a key role in ... CDx submissions to the FDA and other health authorities globally + For late -stage programs, executes the Diagnostic development strategy for a project under… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …clinical issues in consultation with Global Drug Safety and Pharmacovigilance, SVP Late Clinical Development and the Disease Area Heads, as needed. + ... Plans + Leads or oversees the cross-functional clinical development team + Supports Global Clinical Operations...documents for IND/NDA and other regulatory documents + May lead an NDA submission team independently, as needed +… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …scientific and clinical expertise to initiate, propose, design and execute research and development programs for early and/or late -stage assets. This role may be ... The Medical Director, Clinical Development is responsible for facilitating assigned studies, providing...conduct issues. This role reports into the Clinical Program Lead for Cardio-Renal, Clinical Sciences and is expected to… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- … lead of this group. This role plays a key role in driving the global commercial strategy across all stages of development This will be an exciting ... the following:** + Provides commercial assessments of early and late stage molecules across the Regeneron portfolio-helping to inform...building yearly strategic plans + Serves as the commercial lead on the Strategic Program Development Teams… more
- Bristol Myers Squibb (Summit, NJ)
- …BMS** Translational Medicine is part of the Global Research and Early Development organization in BMS and leads late stage clinical, pharmacological and ... development activities for the pipeline and supports late -stage portfolio for regulatory, translational development and...and beyond). Key responsibilities of this role are to lead from the bench for the preclinical support of… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …drive Strategic Program Teams, leading the management and execution from preclinical through late development and life cycle management. + Develop and ensure ... are seeking a highly experienced and dynamic Senior Director Development Project Manager to join our team. The successful...typical day, you will: + Recruit, hire, build and lead a team of high performing, early-career program managers.… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …is preferred. + A minimum of 6 years of industry experience (majority in late clinical development ); however, a candidate with a strong academic background and ... Director, Clinical Sciences, Endocrinology, will play a key role in clinical development programs within the General Medicine portfolio focused on obesity and… more