- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and ... Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for...multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in defining and executing the ... About the Department Our East Coast Global Development Hub brings together the...Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and ... Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for...multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Cambridge and Seattle reflect the full R&D continuum, from early research through late -stage clinical development . Here, we are building for the future, creating ... the safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety...with impact on VP/CVP level. Motivated, collaborative, and science-driven global safety expert who would lead the… more
- Pfizer (Collegeville, PA)
- **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 (Princeton, 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
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Head of the Late -Stage Clinical Development organization is a member of the Organon Research and Development (R&D) ... Officer, and is accountable for: + The leadership of the following teams: Global Clinical Development (GCD), Clinical Trial Operations (CTO), Clinical Data… more
- Bristol Myers Squibb (Princeton, 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 (Collegeville, PA)
- …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
- Pfizer (Collegeville, PA)
- …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 (Bridgewater, NJ)
- …in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global ), in early and late development + Proven record of ... **Job title: Global Regulatory Lead ** + Location: Bridgewater,...development & execution of creative, thoughtful, and robust global regulatory strategies for your products in Sanofi's diversified… more
- Novo Nordisk (Plainsboro, NJ)
- About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and ... Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for...multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and… more
- Bristol Myers Squibb (Princeton, NJ)
- …proof-of-concept trials and will to assure a seamless transition into late -stage development (Phase II-III trials) + Ability to lead and develop a group ... a given Target Product Profile (TPP) + Collaborates with Global Development Operations/ Global Compliance Group... development responsibilities as assigned by Head of Late Development for Neuroscience **Degree Requirements** +… 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 ... 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 (Upper Gwynedd, PA)
- …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
- Takeda Pharmaceuticals (Trenton, NJ)
- …within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ... **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead ...(eg Regulatory Project Management), preferably with 4 Yrs. In Global Regulatory Affairs + Experience working on late… more
- Organon & Co. (Plymouth Meeting, PA)
- …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
- Merck (North Wales, PA)
- …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
- J&J Family of Companies (Titusville, NJ)
- …knowledge of competitors in the therapeutic area and what they are doing in early/ late development and knowledge of labeling aspects + Impact and Influence: Able ... Director, Global Regulatory Leader (GRL) - 2406184564W **Description** Johnson...Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with Health Authorities globally… more
- Spark Therapeutics Inc. (Philadelphia, PA)
- …the pharmaceutical/biotechnology/CRO industry related to toxicology. + Experience in drug development and interaction with global regulatory authorities are ... Project Toxicology Lead **Date:** Oct 9, 2024 **Location:** Philadelphia, PA,...programs at Spark. The individual will serve on Compound Development Teams for pre-clinical stage programs and on Non-Clinical… more
