- Genmab (South Amboy, NJ)
- …our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head of US Medical ... solid tumor therapies and relevant studies Provides US market input to Global clinical development and Global Medical Affairs programs, staying abreast of the… more
- Genmab (Jamesburg, NJ)
- …medical advice on potential new projects (internal and external) Generating/reviewing clinical components of key documents ( regulatory documents, registration ... all clinical documents (eg Investigators' Brochure, protocols, study reports, clinical components of regulatory submissions, safety related documents) Act as… more
- Genmab (Jamesburg, NJ)
- …is essential to fulfilling our purpose. The Role: The Senior Medical Director supports Oncology Clinical Devlopment. Responsibilities: Oversee clinical ... with support of the Safety physician Lead and oversee creation of clinical components of key documents ( regulatory documents, registration dossiers, value… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical , may be called upon to guide a team ... facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with cross-functional project… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... requests, meeting requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including external contractors (eg,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs , is responsible for the development ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs , in… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Pfizer (New York, NY)
- …extensive pipeline of over 50 programs in clinical development. + The Medical Affairs AI Innovation Director will report into the Oncology AI Innovation Head ... as an operational business partner across Oncology Medical, International Medical Affairs and Pfizer US (Medical Platforms) for all Artificial Intelligence (AI)… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …with key stakeholders , including pre- clinical research, Regeneron Genetics Center, regulatory affairs , clinical operations, and others. This role leads ... The Senior Medical Director , Clinical Development will play a...advisory boards), internal stakeholders (eg, Research, Regeneron Genetics Center, Regulatory Affairs , Global Clinical Development,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and business development ... evidence, and creating hope for all facing illness. The Director , Clinical Science (I&I) will lead the...and MAA for the company, drawing on expertise in clinical and regulatory strategy and requirements, both… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …PK analysis plans, study reports, and Clinical Pharmacology sections of regulatory submissions. The Senior Director , Clinical Pharmacology also analyzes, ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and...and creating hope for all facing illness. The Senior Director , Clinical Pharmacology supports the company's … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and business development ... for all facing illness. As a senior member of Clinical Operations, the Senior Director , Clinical... milestones for the company, drawing on expertise in clinical and regulatory requirements, both local and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Medical Director , Clinical Sciences functions as clinical leader of a section of a clinical program (eg, an indication, a new formulation, or a ... advisory boards, patient advocacy groups), internal collaborators (eg, Research, Early Clinical Development, Medical Affairs , Marketing, HE&OR), and internal… more
- Danaher Corporation (New York, NY)
- …diagnostic tools that address the world's biggest health challenges. The Medical Director , Scientific and Medical Affairs position for Beckman Coulter ... will be a part of the Medical and Scientific Affairs team and report to the Senior Director...product development. + Represent the Company in discussions with regulatory agencies about clinical /medical matters relating to… more
- AbbVie (Newark, NJ)
- …internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs , Medical Affairs , and the Commercial ... Strategy and other functions (eg, Clinical Development & Operations, Regulatory , Commercial). The Director , Patient-Centered Outcomes Research, will support… more
- Pfizer (New York, NY)
- … Affairs organization is essential and experience in other medical/ clinical functions desirable. + Prior experience in Project Management, Business Operations. ... **ROLE SUMMARY** The Specialty Care Operational Excellence Director role is an integral member of the...an integral member of the Global & US Medical Affairs Teams, and the Operational & Change Excellence Team.… more
- Danaher Corporation (New York, NY)
- … innovation/new product development. + Represent the Company in discussions with regulatory agencies about clinical /medical matters relating to existing and ... with diagnostic tools that address the world's biggest health challenges. The Senior Director of Medical Safety and Compliance will lead the Medical Safety &… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and business development ... As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will lead the...phase 2A for the company, drawing on expertise in clinical and regulatory strategy and requirements, both… more
- Pfizer (New York, NY)
- …use both internally and externally + Represent Pfizer Oncology Medical Affairs leadership with clinical /professional associations and/or societies, consistently ... **ROLE SUMMARY** The Field Oncology Medical Outcomes Director is a field-based medical colleague responsible for...The role is responsible for educating customers on the clinical and economic impact of Pfizer Oncology medicines and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs , and business development ... milestones for the company, drawing on expertise in clinical and regulatory requirements, both local and...Director , MSLS will be responsible for MSLS strategy, clinical program oversight, and support of clinical … more
