- 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
- Merck (Rahway, NJ)
- …health. **Responsibilities** **:** + Supervises a group of statisticians in Late Development Statistics. + Provides biostatistical and operational leadership ... teams for the strategic planning and execution for product development and worldwide regulatory submissions. + Lead ...product development and worldwide regulatory submissions. + Lead a team of statisticians and the statistical programmers… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and implements registration strategy plans (RSP) and ensures cross-functional alignment with overall development plan. + Is assigned as lead contact with FDA and ... pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines… 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
- 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
- Pfizer (New York, NY)
- **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. (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)
- …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
- Insight Global (New York, NY)
- …and sustain various show brands throughout their multi-platform lifecycle. This role will lead the development and launch of innovative consumer efforts across a ... will be responsible for overseeing the brand strategy, planning, development , execution and coordination of marketing campaigns to build...diverse range of priority programming, spanning unscripted, late night, live events & specials. This role is… 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
- 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 (Basking Ridge, NJ)
- …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
- 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)
- …and development and execution of clinical pharmacology strategies for late -stage development programs from Proof-of-Concept (Phase 2a) through worldwide ... and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical… more
- Merck (Rahway, NJ)
- …, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics. + Lead the interaction with ... drugs and vaccines for the benefit of patients and global human health. Responsibilities: + Serves as a statistical...to a development project as needed + Lead biostatistics in early or late clinical… more
- Merck (Rahway, NJ)
- …for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical ... Medicine at our Research Division is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences… more
- Sanofi Group (Bridgewater, NJ)
- …May be requested to lead GRT meetings. + Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with ... the development and update of the core global dossier / collaborates with regional lead ...experience (regionally and global ), in early and late stage. development of multiple modalities; experience… more
- Organon & Co. (Jersey City, NJ)
- …and/or coordinate with Regulatory CMC scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC strategies to ensure high ... women's health across diverse therapeutics including Biosimilars and will encompass late -stage development products and commercially approved compounds. The… more