- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development , an organization dedicated ... for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated ... for coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if… more
- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the ... to the development of new compounds The Senior Clinical Director may: Oversee the Clinical...To accomplish these goals, the Senior Clinical Director may: Author detailed development documents, presentations,… more
- Merck & Co. (Rahway, NJ)
- …activities in his/her area of responsibility.To accomplish these goals, the Senior Director may:Author detailed development documents, presentations, ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in… more
- Merck & Co. (Rahway, NJ)
- …for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for development and implementation ... associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role ... of the progress includes the stakeholders at the Alliance Partner.- Drive the development of Areas of Interest (AOI) for Externally Sponsored Research (ESR). Align… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development ... patients treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role, the incumbent will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area ... requirements/precedence.Represent Daiichi Sankyo's regulatory group in internal and external development project meetings.Provide guidance to peers and cross-functional team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads ... submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with supervision. Prepares content templates and leads technical team in preparation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will...transition of rising star early assets to late phase development , based on the vision for the function. As… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively ... wide range of functions in Daiichi Sankyo (DS). Reporting to the Sr. Director , Enterprise Program Management, this position requires a capable leader with strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director , GMA Oncology ADC (Global Medical Affairs team lead for ... medical education and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders.SummaryThis position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development ... Team leader as the Project Management lead on drug development projects. This position can be assigned to any...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ADC portfolio plus emerging pipeline assets to advance our research and development . This role will lead workstreams with highly matrixed cross-functional and ... and Commercial, and Medical Affairs. Responsibilities will be both process/capability development for a relatively new functional group and high-complexity disease… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... & Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on ... quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical issues,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... global regulatory authority requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) ... level, and interacts with regional and global project team members, senior management, and outside vendors.Responsibilities:Responsible for all aspects of Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direct reports or staff of the global function to support drug development and life cycle management. Represents the function in global regulatory/heath authorities' ... vision and strategy for the function. Accountable for the management, performance, and development , both technical and career, of direct reports, and mentors or acts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic… more
