- 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 ... Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership… 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
- 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)
- …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)
- …stakeholders. He or she will aid in the construction of clinical development plans, clinical protocols, and in submission of certain regulatory documents. ... defining key scientific questions and plan. Align closely with the Senior Translational Strategy Lead.Construct translational plan documents, biomarker data analysis… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the real-world setting.Contributes to creation and improvement of Clinical Development processes. Education :MD required; prefer Board certification in ... areas centered around rare diseases and immune disorders. Summary A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development … 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads ... guidances. Serves as RA CMC representative supporting company initiatives. Qualifications: Education and Experience:Bachelor's Degree in Life Science required.M.S./PhD. preferred… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of strategic ... implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new...Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior … 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) ... globally in partnership with other cross-functional leaders.- Contribute to Clinical Development initiatives, global education , and process development … 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 ... education and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within legal… 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
- Tris Pharma (Monmouth Junction, NJ)
- …to hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior ... privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet patient needs.… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- OverviewReporting to the Senior Director of Facilities & Safety and under limited direction, the Facilities Director will oversee the day-to-day operations ... of the Institute's facilities and physical plant. The Director will play a pivotal role in effectively managing the Facilities Department to ensure a safe and… 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)
- …Project Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III ... approved budgets.- Functional Budget Planning - Manages and is accountable for the development and control of functional budget in support of global operations of RD… 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)
- …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)
- …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
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