- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …across regions. - Interact with clinical investigators, academic organizations, co- development partners, and strategic outsourcing. CS Group Lead may ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical...will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. JOB SUMMARYThe Director , Clinical Project Management will manage assigned project (s), including program's ... strategic direction, integrated project plan, alliance management, cross-functional deliverables...development plans and corporate objectives. Advanced understanding of clinical research and the clinical drug … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical ...Phase 2 and Phase 3 registrational studies: Provides the strategic direction to BD&O for EDC, edit checks, data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory, ... and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role ... in working with the team to execute the global clinical development plans of brensocatib for the...company in outside groups.Contribute to the strategic development of early and late stage clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development . Internal relationships include ... strategic documents, including NNI Evidence Generation Plans and Product Development Plans Clinical study management: Provide regional medical & scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and global stakeholders, the Director of S&PE will establish the North America Clinical Development (NACD) strategy for the development and execution of ... Operational Excellence & Delivery function (OED) is seeking a Director of Site & Patient Engagement (S&PE). In collaboration...experience P referred 5 years of team leadership in clinical development /trials Expertise in ICH-GCP principles and… more
- Merck & Co. (Rahway, NJ)
- …technical device development team(s) supporting individual drug assets currently in clinical development with line of sight to commercial filing and launch. ... Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device... strategy, including line of sight to first device clinical entry, for drug assets in the preclinical /… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborations. The global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing… more
- Merck & Co. (Rahway, NJ)
- …innovation and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director , the Finance Senior ... financial planning, forecasting and analytical support to our Research & Development Division Oncology Clinical DevelopmentForecast grant spend as well… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (North Wales, PA)
- …Company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Executive Director /Associate Vice President in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (North Wales, PA)
- …execution of integrated project plans appropriate to the project's phase of development and complexity. This includes integrating strategic and tactical input ... Advanced degree (eg, MS, MBA, Ph.D., PharmD) preferredExperience and knowledge of clinical drug development strongly preferred; including the different phases of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GCO Leadership, GCO Study Management, CROs, Procurement, Legal, Compliance, Finance, Clinical Development , Global Project Management, and Functional Quality ... Financial Reporting & Strategy position provides leadership in strategy and process development for Global Clinical Operations (GCO) to ensure the implementation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for the development and implementation of the overall strategy, key strategic imperatives, positioning & messaging for all products within the Mature Business ... tactics and market shaping initiatives including but not limited to KOL development , advisory boards, clinical communications and medical education programs… more
- Merck & Co. (Rahway, NJ)
- …benchmarking, and recommendations for commercialization strategies, portfolio prioritization, clinical development /research strategies, and Business ... Development initiatives.Partnering with discovery and clinical colleagues to shape research programs.Analyzing select competitor activities through strategic … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (Rahway, NJ)
- …financial support to Global Clinical Supply (GCS) and Global Clinical Development (GCD) for Drug Supply (both externally-purchased comparators and ... but not limited to the Global Clinical Supply team and the Global Clinical Development Finance team to ensure coordinated planning and execution of client… more
