- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance. This is a hybrid ... commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership and… more
- Eisai, Inc (Queens, NY)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing is responsible for developing and implementing strategic marketing programs for ... to these changes Ability to take on board new and complex clinical information and adapt it strategy Experience in neurodegenerative disease(s) required Experience… more
- Merck & Co. (Rahway, NJ)
- …Our company Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible for:-Evaluating pre- clinical and… more
- Sun Pharmaceutical Industries, Inc. (Jamesburg, NJ)
- Director , Clinical Operations/CPM Sun Pharma Advanced Research Company, Limited Summary The Director , Clinical Operations/CPM is responsible for the ... development of a Clinical Operations Team in the United States. Work with...Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates… more
- Sun Pharmaceutical Industries, Inc. (Jamesburg, NJ)
- Associate Director , Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director , Clinical ... Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to identify… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and...Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and… more
- Merck & Co. (Rahway, NJ)
- …Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre- clinical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … 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)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study ... of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of the drug.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... with board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead ... Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) and key… more
- Merck & Co. (Rahway, NJ)
- …Solid Dosage (OSD) and Sterile operations, the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our Company's Research Labs ... facility (inclusive of RY119) supports the formulation and filling of clinical , stability, and developmental Sterile, OSD and Inhalation supplies. These facilities… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Market Access, Immunology T he Director , Global Market Access, Immunology will play a leadership role in ... strategy for assets within our Immunology portfolio. In this role, the Director will lead the development and execution of global market access strategy,… more
- Sun Pharmaceutical Industries, Inc. (Jamesburg, NJ)
- Job Title: Head of Clinical Data Management Job Grade: G6/G7 Department: Biostatistics and Data Management FLSA Classification: Manager's Job Title: Head of BDM ... responsibilities will include effective leadership, planning and oversight within the Clinical Data Management (CDM) function as well as facilitating collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead ... and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in...CS Asset Leads who are managing a team of clinical scientists for the writing of protocols / amendments… more
