- 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
- Bristol Myers Squibb (Cambridge, MA)
- …(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
- 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
- Pfizer (Cambridge, MA)
- …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
- Caris Life Sciences (Boston, MA)
- …several of these departments, including but not limited to Discovery, Early/ Late Development , Biomarkers, Translational Medicine, Precision Medicine, Clinical, ... experience, with at least 8 years in Biopharma business development roles or as aS&E Lead at a biopharmaceutical company. + Business DevelopmentProven business … more
- Pfizer (Cambridge, MA)
- …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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Respiratory (GLMAR) is a board-certified, ... support the Global Head of Clinical Affairs in the conception, development , and implementation of impactful clinical investigations to arrive at relevant study… more
- Olympus Corporation of the Americas (Westborough, MA)
- …other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, ... support the Global Head of Clinical Affairs in the conception, development , and implementation of impactful clinical investigations to arrive at relevant study… 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
- Sanofi Group (Waltham, MA)
- **Job Title:** Global Clinical Development Strategy Expert - Vaccines **Location:** Swiftwater, PA or Waltham, MA **About the Job** This role in the Meningitis ... one or more clinical trials and/or programs in the development of a pentavalent meningococcal vaccine. The Global...exposure to diverse array of programs in early and late -stage development or + 3+ years or… 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
- 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
- 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
- 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
- Novo Nordisk (Lexington, MA)
- …cross-functional (and perhaps global ) projects + Experience from early to late -stage drug development preferred + Knowledgeable of the Novo Nordisk value ... 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
- 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
- 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