- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …to help us shape the vision and strategy of our software products in the clinical domain.The Product Manager in this role should be able to define product strategy, ... to deliver high value product solutions that improve how we run clinical trials and regulatory submission for our patients, partners, and colleagues.As a… more
- Merck & Co. (Rahway, NJ)
- …support drug substance process development activities to enable and accelerate early and late-stage pipeline programs using fed-batch and continuous manufacturing ... high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The candidate will be a member of the… more
- Merck & Co. (Rahway, NJ)
- …and improve lives around the world.Reporting to the Associate Vice President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director, Digital ... Regulatory and Safety, will lead our efforts in transforming regulatory submissions and pharmacovigilance through modern platforms and responsible generative… more
- Merck & Co. (Rahway, NJ)
- …peptide/protein modalities). We collaborate closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial ... shape and execute strategy for biological characterization in all stages of clinical development, as well as for commercialization and in line commercial projects.… 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
- 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)
- …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
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Jobleads-US (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… 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
- Organon & Co. (Jersey City, NJ)
- …Medicine and Early Development (TMED) team spanning discovery through early clinical development. The Non- Clinical Safety Assessment Representative ... is expected to participate in cross-functional development programs with early clinical development, late- clinical development, regulatory affairs, safety… more
- Jobleads-US (New York, NY)
- …providing effective feedback and performance development. Identify critical capabilities and lead initiatives to build a future-ready workforce in client areas, ... 2020, further strengthened Menarini's oncology portfolio, adding both commercial and clinical -stage assets. Tagraxofusp is a novel, first in class targeted therapy… more
- Organon & Co. (Jersey City, NJ)
- …for global regulatory submissions. **Responsibilities** + Provide support for the Biopharmaceutics Lead on early clinical development programs to ensure ... and internal knowledge-sharing events. + Contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or… more
- FleishmanHillard (New York, NY)
- …or opportunities. We're seeking energetic professionals with good instincts, who are early adopters and self-starters, and have an adventurous spirit and passion for ... projects simultaneously. + Ability to translate large amounts of clinical data and information into lay language that resonates...with the ability to develop strong media pitch angles, lead pitch teams and pitch story ideas to reporters.… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Clinical Lead , Early Clinical and Experimental Therapeutics **Location: Cambridge, MA** Morristown, NJ **About the Job** Are you ready to ... accelerate progress. Join our state-of-the-art ECET department as a Clinical Lead , ECET and you'll drive the...and you'll drive the translation between preclinical development through early clinical development and beyond, while enjoying… more
- Pfizer (New York, NY)
- …of the development team to establish, lead , coordinate, and execute the early oncology clinical development plan(s). You will lead the development ... **POSITION RESPONSIBILITIES** + Partner closely with the Global Development Lead (GDL) in the execution of the clinical...or strong understanding of Oncology Drug Development especially in Early Development + Strong knowledge of clinical … more
