- Merck & Co. (Rahway, NJ)
- …pre- clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.Providing ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for...the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel is informed… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …drive efficient, discovery facing innovations and decision-making strategy for all elements of early development. They will lead various early development ... sessions to identify gaps and challenges in the device innovation space; lead efforts to co-develop solutions.Advocate for early consideration of device… 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
- Merck & Co. (Rahway, NJ)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, ... and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and...assigned to a development project as neededLead biostatistics in early or late clinical development planning to… 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)
- …key function within the Translational Medicine and Early Development (TMED) team. Non- Clinical Operations Lead will report to the Non- Clinical Safety ... **Job Description** **The Position** The Non- Clinical Operations Lead within the Non- Clinical Development Team (NCD), is responsible for operational… 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)
- …Excel. + A minimum of five to six years-experience in translational medicine and early clinical development within the pharmaceutical or biotech industry with a ... Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting in the...TMED Operations. The CTM will support the TMED Operations Lead to plan and execute studies including, but not… more
- Merck & Co. (Rahway, NJ)
- …agencies, and health systems globally. The ability to successfully participate in and lead cross-functional teams is a critical part of this role. The Executive ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses,… 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)
- …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)
- …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)
- …& 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
- 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
- Organon & Co. (Jersey City, NJ)
- …field. + Five years of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs, Pharmacovigilance, Regulatory Affairs, ... achieving the target product profile and value proposition. + Lead the establishment of the integrated and operational plan...programs in one or more phases of development (discovery, non- clinical , Phase 1, 2, 3, launch). + Worked effectively… 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
