- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary Senior clinical operational leader accountable for operational planning and execution of FIH, ... clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level.Responsible...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionLocation:-Rahway, New JerseyDepartment:-Pharmaceutical Operations and Clinical Supply-Position OverviewJoin us at the forefront of pharmaceutical ... innovation! The Formulation, Laboratory, & Experimentation Early Development Center (FLEx EDC) is a state-of-the-art Non-Sterile, predominately Oral Solid Dose… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. SummaryMedical Affairs leader for the portfolio of early asset compounds under the supervision and leadership of the Global Medical ... Affairs (GMA) Franchise Head. Develops the GMA early strategy and tactical plan and leads the execution...and communication- Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and planning alignment across the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio ... The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject...Organization. The Director can serve as an SDL at early stages before an SDL is assigned or provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to collaborate and establish a well-connected network with other Early /Late Leaders and Clinical Operations Leadership preferredDemonstrated ability ... including feasibility, functional excellence, recruitment and retention, patient voice and clinical trial diversity. The leader may also strategize and establish… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated ... key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments… more
- Organon & Co. (Jersey City, NJ)
- …Translational Medicine and Early Development (TMED) Department at Organon. The Clinical Pharmacology Lead also will be responsible for the rationale, study ... guidance and support the approved early development plans. The Clinical Pharmacology Lead will serve as the medical monitor and/or study director responsible… more
- Merck & Co. (Rahway, NJ)
- …and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for ... validate novel clinical biomarker platforms.Development and execution of the early clinical development strategy for novel therapy/Immunology programs from… more
- Parexel (Trenton, NJ)
- …highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead , Master/Senior Medical Review Officer who is looking to draw upon their ... to bring safer, more effective therapies to patients worldwide. You will: - Lead strategic regulatory initiatives across diverse product types and global markets -… more
- Merck & Co. (Rahway, NJ)
- …validation of digital pathology algorithms.Interface with scientists and physicians in early and late-stage clinical development to execute histopathology-based ... Molecular Biomarkers is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Insmed Incorporated (NJ)
- …internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs from… more
- Merck & Co. (Rahway, NJ)
- …To achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all ... to upstream processing and recombinant expression of drug candidates in early - and late-stage development.Responsibilities include, but are not limited to:Serve as… more
- Insmed Incorporated (NJ)
- …Do: Lead development of HEOR strategy for gene therapy products from early clinical development through product launch and life cycle management.Ensure HEOR ... across the company including market access, marketing, medical affairs, and clinical development to understand and support Insmed's business needs. This is… more
- Merck & Co. (Rahway, NJ)
- …Scientist, you will be part of a team developing innovative analytical methodologies for early to late phase programs with application to drug substance and a broad ... and data analysis. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities, in no particular order and by no… more
- Genmab (NJ)
- …supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead… more
- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) engaged across the entire product lifecycle-from early development through commercialization and post-market activities-ensuring integration of ... and coach to the HF team and key stakeholders across R&D, clinical , regulatory, marketing, manufacturing, and quality functions.Educate and build awareness of HF… more
- Parexel (Trenton, NJ)
- …and serve as a key liaison with Health Authorities. What You'll Do - Lead regulatory strategy for assigned programs from early development through approval - ... **Join Parexel as a Regulatory Affairs Strategy Lead ** Are you a strategic thinker with a...Coordinate cross-functional regulatory activities (CMC, nonclinical, clinical ) to meet key milestones - Conduct Regulatory Risk… more
- Merck & Co. (Rahway, NJ)
- …scope and accountability will encompass the entire lifecycle from early development through lifecycle management, providing critical technical strategic oversight ... seek out, anticipate, and solve significant scientific and technical challenges. Lead complex investigations into technical challenges related to design,… more
- Parexel (Trenton, NJ)
- …across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, ... maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a...task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician). **Medical… more
- Parexel (Trenton, NJ)
- …is your opportunity to make a real impact. You'll contribute to both early -stage development and approved programs, helping to shape the future of life-saving ... and Controls (CMC) regulatory strategies. You will support both early -stage development programs and marketed products, ensuring compliance with global… more
