- 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)
- …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
- 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)
- …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
- 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)
- …& 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Job Title** Director, Early Clinical Development - Immunology **Functional Area Description** ... The Early Clinical Development - Immunology function is part of a...protocols + Strong leadership skills with proven ability to lead and work effectively in a team environment **Travel… more
- Pfizer (New York, NY)
- + **ROLE SUMMARY** + Support clinical trials and the development strategy for early development assets and lead development programs with a focus on multiple ... board to objectively consider and implement feedback. + Drive innovations in early clinical development, and the application of translational oncology and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …exploratory development, including, CMC (small molecules and biologics), biology, toxicology, clinical pharmacology, ADME/DMPK, early clinical development, ... **Senior Director, Early Development Team Lead ** **Role Summary:**...bring differentiated medicines to patients. The EDT Leader will lead asset focused multi-disciplinary teams from pre- clinical … more
- Bristol Myers Squibb (Princeton, NJ)
- …ensuring a franchise overall portfolio view + Provide strategic insights into the clinical development plans + Lead search and evaluation activities on business ... and into lifecycle management Leadership and Matrix Management + Lead and develop a group of Clinical ...+ Partner and interact with colleagues from Research and Early Development who design and implement first in human… more
