- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary The Global Oncology Medical Affairs (GOMA) Director , Program Management & Operational Excellence provides strategic planning ... and operational management oversight of GOMA projects, activities, and budgets.The Director , Program Management & Operational Excellence is responsible for… more
- Merck & Co. (Rahway, NJ)
- …development teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager ( Program CSPM) serves as the ... spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic and operational plans for all clinical supply… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department ... at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (Rahway, NJ)
- …decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of ... pharmacometricians.The Director -Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating one or more of the following… more
- Merck & Co. (Rahway, NJ)
- …drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong, ... to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of pharmacometricians with diverse… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and execution ... release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs,… more
- Merck & Co. (Rahway, NJ)
- …to join the Global Safety Center of Excellence (CoE) team as an Associate Director , Safety Programs CoE.- This individual will be responsible for the management of a ... control safety hazards for manufacturing, research and office personnel.Conduct safety program reviews at company facilities across the globe.Audit safety records… more
- Merck & Co. (Rahway, NJ)
- …journey to become the premier "Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the HHDDA ... domain level analytics ready datasets.experience in large scale multi country program rollout with cross divisional and market stakeholdersStrategic thinking, risk… more
- Merck & Co. (Rahway, NJ)
- …one or more V&I, Outcomes Research teams across the Oncology GI cancers program . Primary Responsibilities: Support value evidence teams in Oncology and contribute to ... value evidence strategies for in-line and pipeline products. Obtain senior management approval of value evidence generation plans. Provide outcomes research leadership on cross-functional regional and global teams.Critically assess drivers and barriers to… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management, enterprise strategic planning, risk management, as well as strategic ... ensure effective implementation and cross-functional engagement. Position Description: The Director of Commercial Strategy will support strategy development for… more
- Merck & Co. (Rahway, NJ)
- …procedures, and tools.Maintain a high level of engagement in the program -specific design controls process and design history file development.Stay current with ... new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.Enhance our Company's professional image and competitive advantage through publications, presentations, patents, and professional… more
- Merck & Co. (Rahway, NJ)
- …design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and commercial market(s) ... approval(s).Define design input(s)/ output(s) and lead associated combination product design verification plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s).Lead establishment of test methodologies, including method… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, leadership,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product into and out of CMO's organizations.Deviation and Complaint Investigation Program : Provides support to the investigation of deviations and complaints in ... order to ensure a timely manner activity and a protective solution to avoid any risk to the quality and safety of commercial and investigational drug products supplied through DSI and DS affiliates. Qualifications: Successful candidates will be able to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... development and implementation of DM reporting strategy and solutions at the program level to achieve/exceed quality, time, and cost objectives embracing agile… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L. ... gaps and influences the project environment to address gaps that impact the program /project.Manages the planning and use of program /project resources and works… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due ... diligence activitiesQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Master's Degree or equivalent preferred… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... events based upon approved Safety Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Lead the development and roll out of a broader training and development program for GBD and extended members engaging in external innovation. This will range ... from working with GBD leadership and HR Training and Development to identify the core competencies and determining where we can leverage external programming and where internal training and communications are required. In addition this role will create and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …define problem statements and provide efficient solutions required- Demonstrated project/ program management experience required- Certification in one or more ... SuccessFactors modules including Employee Central, Onboarding, Recruiting, Performance, or Compensation preferred- Hands-on experience implementing a global HRIS solution preferred- Solid influence and negotiation skills. Strong vendor management skills… more
