- Merck & Co. (Rahway, NJ)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical ... the scientific planning and execution of one or more clinical trials or significant aspects thereof.- In this position,...monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the … more
- Merck & Co. (Rahway, NJ)
- …your career.This role will report directly to the Immunology Therapeutic Area Lead in Translational Medicine.Primary responsibilities for the Senior Principal ... Job Description Senior Principal Scientist Translational Medicine, Immunology Translational Medicine...for novel Immunology assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily ... Engineering). The role is on-site and reports to the Sterile Pharm Ops Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical … more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, ... ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,-… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a… more
- Merck & Co. (Rahway, NJ)
- …biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile Process ... Engineer role at the Senior Specialist level will leverage the individual's leadership, technical,...and communication skillsets to drive the success of our clinical manufacturing facility and organization. As the facility is… more
- Genmab (NJ)
- …immunology experience preferredDemonstrated experience authoring protocols, investigator's brochures, and clinical study reports. Senior level candidates should ... At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the...us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart… more
- Merck & Co. (Rahway, NJ)
- …in the late development of assets within the pediatric section of the Vaccine Clinical Development TA.May serve as a senior therapeutic area content expert ... the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of...into research and business development priorities and prioritization of clinical assets.-May serves as the senior liaison… more
- Genmab (NJ)
- …Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until proof ... of concept, and/or as trial responsible statistician.Responsibilities:Compound/Indication LevelAct as lead and main point of contact related to Statistics for… more
- Merck & Co. (Rahway, NJ)
- … clinical , regulatory, formulation, commercial and other key company functions. Lead the Device Engineering Sub-Teams focused on development of design requirements ... (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead / support/ oversee clinical supplies production with respect to device… more
- Eisai, Inc (Nutley, NJ)
- …a team of Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study inspections from preparation through ... we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... audits and inspections Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... areas of the business Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is tasked ... ED&AA, IT, Ethics and Compliance, Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues. Externally,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, ... Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues, to deliver… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts ... treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role,...KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- Title: Sr. Director, Clinical Pharmacology Reports to: SVP, Clinical Development Location: US - Remote Position Overview: As Company continues to advance the ... a highly motivated scientist to be responsible for designing clinical studies and performing, interpreting, and reporting Pharmacokinetic/Pharmacodynamic (PK/PD)… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
