- Merck & Co. (North Wales, PA)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... Job DescriptionThe drug development Project Manager is part...Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core… more
- Merck & Co. (North Wales, PA)
- …OR Master's + 6 years OR PhD/PharmD + 2 years Pharmaceutical and/or-clinical drug development experience. Degree in life sciences, preferred.NOTICE FOR INTERNAL ... of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members through… more
- Merck & Co. (North Wales, PA)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Executive Director / Associate ... of clinical medicine experienceMinimum of 1 year of industry experience in drug development or biomedical research experience in academiaDemonstrated record of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... Pharmacometrics/ Quantitative Clinical Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. SummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... generation (checklist, process map, etc.), change management and detailed analyses. The Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submissions and approvalsExtensive experience developing companion diagnostics and devices.Experience of drug development and drug regulatory procedures. ... and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with developing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... development and application.Align QSP model deliverables with the Model-Based Drug Development (MBDD) plansUtilize virtual population workflows and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of established and new assay technologies such as NGS, IHC, PCR etc.Knowledge of drug development process and an understanding of how diagnostic development ... support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role...CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and formulating business relevant strategic recommendations Strong understanding of drug development , commercialization, and lifecycle management Works ... and recommendations through formal and informal channels Leadership and development : Capable of assuming role of Director ...and development : Capable of assuming role of Director MAPA Insights when needed, such as representation on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …. Are you ready to maximize your potential with us? The Position The Associate Director of Enterprise Functions Insights & Analytics will provide holistic, ... and formulating business relevant strategic recommendations Strong understanding of drug development , commercialization, and lifecycle management Works… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.Participate in global product team meetings ( development ... implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and other vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. This position provides leadership ... ensures quality delivery of medical coding for clinical trials, clinical development , and regulatory submissions. Develops and proposes strategies for medical coding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Drug Substance, Drug Product, or New Modality) process and product development preferred Travel Ability to travel up to 30%. Global and domestic travel ... rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality)...and associated teams for internal and external sites and development projects. Serve as the main interface to internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Experience Qualifications- At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical ... activities assigned, eg for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Review CRF;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC ... plan.- Represent CMC development project teams on cross-functional drug development project teams with a predominately operational focus; ensuring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Bristol Myers Squibb (Princeton, NJ)
- …decision-making process with a BMS Global Program Team (GPT) in early and/or late development . The Associate Director PM will provide content expertise to ... for development and lifecycle management programs, the Associate Director GPM works to ensure that...operating model. **Key Responsibilities** + **General expectations of a Drug Development Project Manager (PM) at BMS:**… more
- Merck (North Wales, PA)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... **Job Description** The drug development Project Manager is part...Division organization of our company. **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core… more
- Bristol Myers Squibb (Princeton, NJ)
- …, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development , Regulatory, IT, Audit, Finance and HR to build and ... compliance program into the Worldwide Medical, R&D and Global Drug Development Organizations . In this role,...their decisions. + Under the direction of the Senior Director , US and Above Market Medical and Market Access… more
- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Commercial Drug product Manufacturing and Packaging** ... technology platforms and advanced analytics capabilities to accelerate discovery, development , and help bring novel therapies to patients sooner....The Associate Director , Commercial Drug product Manufacturing and Packaging… more
