- Pfizer (Cambridge, MA)
- **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
- Takeda Pharmaceuticals (Boston, MA)
- …Takeda as a Scientist - Analytical Development (AD) - Late Stage Development where you will independently lead efforts in development of analytical ... within expertise for review. As part of the Analytical Development team, you will report to Associate Director, Analytical...cross-functional issues. + Identify topics for initiatives and may lead local/ global initiatives as directed by senior… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Analytical Development , it is expected that the individual will independently lead efforts in development of appropriate scientific methods and technology, ... The individual is expected to have acquired expertise in benchmarking analytical development trends within industry and demonstrate an in-depth working knowledge of… more
- Novo Nordisk (Lexington, MA)
- 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
- Sanofi Group (Cambridge, MA)
- …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
- Takeda Pharmaceuticals (Lexington, MA)
- …company to inspire you and empower you to shine? Join us as a Manager, Global Clinical Supply Chain Operations Lead in Lexington, MA reporting to the Director, ... bold mission. **_GOALS:_** + Under the direction of the Global Clinical Supply Chain (GCSC) Team Lead ,...Global Clinical Trials and other supportive research or development needs, and works with both internal and external… more
- Takeda Pharmaceuticals (Boston, MA)
- …and/or collaboratively conducts PK and PK/PD analyses during late -stage lead optimization through early pre-clinical development and collaborates in PK/PD ... to shine? Join us as Senior Scientist, DMPK Project Lead in our Cambridge, Massachusetts office. As a member...in our Cambridge, Massachusetts office. As a member of Global DMPK organization, you will also have cross-site interactions.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the best of my knowledge. **Job Description** **Role Objectives:** + Leads the development of a strategic integrated evidence generation plan for TAK-079 and HAE. ... teams and through interactions with cross-functional partners. + Leads the development of peri -and post-approval interventional and RWE prospective study design… more
- Bristol Myers Squibb (Cambridge, MA)
- …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 (Cambridge, MA)
- **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 (Boston, MA)
- …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
- Pfizer (Cambridge, MA)
- **Job Summary** Asset Specific + The Obesity Development Lead will be the single point of accountability for Obesity-related programs within PRD Clinical ... Development + Oversees and directs Medicine Team Leads, Global Clinical Leads, and Category Clinicians on obesity-related programs... assessments and the provide expertise / leadership for late - development plans for early assets with the… more
- Organon & Co. (Boston, MA)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …Provide global regulatory oversight and execute regulatory activities on late -stage development in multiple indications, device platforms, cell line changes; ... Advice and PMDA, (Japan) Scientific Advice; Lead the development of high level global regulatory supplemental biologic application sBLA strategy and the KO… more
- Bristol Myers Squibb (Cambridge, MA)
- …process with a BMS Global Program Team (GPT) in early and/or late development . The Associate Director PM will provide content expertise to the ... Manager (GPM) to lead sub-teams of the Global Program Team (GPT) to drive the development...the broader portfolio value. + **Associate Director, PM (Early Development / Late Development )** + At the… more
- Sanofi Group (Cambridge, MA)
- …This encompasses drug substance (DS), oral drug product (DP) and analytical development , DS/DP clinical manufacturing, and support of global regulatory filings ... and commercial processes. **Main responsibilities:** + Reporting to the Global Head of Synthetics CMC Development , you...for all synthetic/small molecule drug candidates + You will lead a global organization (~50 FTEs in… more
- Takeda Pharmaceuticals (Boston, MA)
- …and/or collaboratively conducts PK and PK/PD analyses during late stage lead optimization through early pre-clinical development and collaborates in PK/PD ... + Shows examples of leadership and collaboration with multi-disciplinary cross-functional global development and strategy teams + Experience in molecular… more
- Novo Nordisk (Watertown, MA)
- …Cambridge, our teams reflect the full scope of R&D, from early research through late -stage clinical development . We are building for the future by creating a ... the cardiometabolic therapeutic areas across Research & Early Development (R&ED) organization the individual will lead ...with scientists within the cardiometabolic therapeutic areas across the global Research & Early Development (R&ED)… more
- Takeda Pharmaceuticals (Boston, MA)
- …publications. **ACCOUNTABILITIES:** + Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects ... you to shine? Join us as an Associate Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA office. At Takeda, we are transforming the… more