- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director - Launch Operations will play a pivotal role in guiding the therapeutic areas ... to business growth and success. Relationships Reports to Executive Director Launch Excellence. Collaborates with cross-functional teams, including finance, HR,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Executive Director , Head of Launch Excellence will play a pivotal role in guiding the therapeutic ... managers, business operations and analytics. Essential Functions Strategic Launch Planning: Lead with strategic approach to launch plans, ensure a unified view… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... determining audit targets for GxP systems.ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director , Data Quality and Integrity is essential in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision ... expertise in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors,… more
- Merck & Co. (Lower Gwynedd, PA)
- …Bioanalytics (PDMB) Regulated Bioanalytics at Spring House Innovation Park (SHIP) is seeking a Director to join our company and lead a team of approximately 10 ... solutions that enable and accelerate vaccine clinical development. The Director will report to the Executive Director ...primary role of the successful candidate will be to lead a team to support vaccine early development (Phase… 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 ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of ... clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of laboratory data deliverables to support drug development processes and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... professionals at strategic non-project team and at MA strategic discussions. Lead the Quality Reviews of respective product...team and at MA strategic discussions. Lead the Quality Reviews of respective product profile to ensure appropriate… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable to ensure a holistic Regulatory centric D ata M anagement ( R DM) capability ... c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level strategic...are not limited to: - - Data Centric Submissions: Lead the data submissions team that is accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …training and support materials for end-users, handling of queries, troubleshooting, and quality control. Lead or support consulting and implementation projects in ... formats, correct inaccuracies, and validate the cleansed data against defined quality metrics.Implement and manage robust data governance processes to ensure ongoing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product ... commercialization).Responsibilities- Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of group members. This position also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and leads the execution for ... of the global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs ... Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management. Drives and leads the successful execution of ... Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies.… more
- Merck & Co. (North Wales, PA)
- …reaching patients around the world.Under the broad guidance of the Executive Director , GPAM, the core responsibility of this Value and Implementation Project Manager ... their team's strategy.- The staff manager will be expected to monitor quality of project management deliverables and assign accountability for the maintenance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensuring treatments are cost-effective and have a positive impact on patient quality of life. This involves analyzing data to inform decisions about medical use, ... with the Daiichi Sankyo US Business, and the Daiichi Sankyo Global IEP network.- Lead the design and execution of the US HEOR RWE strategy and evidence generation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject matter ... submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... bring the latest knowledge in these fields, ensuring high quality and efficiency. This role will be responsible for...a meaningful impact on clinical development at the program level. Lead projects to enhance processes within CSPV, including the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionAs Formation Bio's dedicated IP Counsel at the Director level, you will own the IP function for our rapidly growing pharma ... company. Reporting to the Senior Director , you will operate autonomously to create and execute...competitive, evolving market.Responsibilities IP Strategy & Execution: Develop and lead IP strategies to maximize the value of both… more
