- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Senior Director, Forecasting & Business Analytics is to lead the forecasting and financial and analytical support of commercial assets. In addition, ... will lead the forecasting process supporting the Business Development team through financial analysis and valuation process for investment and other business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics ... centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring)...activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior Specialist to lead operations supporting enzyme process development and ... characterization. Our team is part of Continuous & Expression Technologies (CET) within the Process Research & Development - Enabling Technologies (PR&D - ET) group,… more
- Merck & Co. (Rahway, NJ)
- …in Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication ... its' Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (Rahway, NJ)
- …by identifying areas of high impact and translating into messaging that resonates with senior leadership.Develop and assess team data and analytics via KPI ... type role preferred (including experience working in managed care /health systems) Team lead or management experience preferred but not… more
- Formation Bio (New York, NY)
- …is ideal for someone passionate about building scalable infrastructure at the intersection of data engineering and applied AI. You'll lead efforts to ingest and ... to power retrieval, enrichment, and relationship modeling. Platform Operations & Infrastructure Lead architectural decisions across the data platform to support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and statisticians, and is tasked with ... and vision.Build and evolve the Data Science team to meet internal and market needs. Lead ...senior leaders to drive strategic analytics transformations.Partner with Data Strategy, AI Engineering, and IT teams to ensure… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls ... biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC team… more
- Formation Bio (New York, NY)
- …are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team ... and more efficiently.About the PositionWe are looking for a Senior Software Engineer, Applied AI to join our dynamic... Software Engineer, Applied AI to join our dynamic team at Formation Bio. As we continue to revolutionize… more
- Tris Pharma (Monmouth Junction, NJ)
- …our proprietary science and technology.Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and ... a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. We… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is tasked with providing strategy ... vision Build and evolve the AI Engineering & Automation team to meet internal and market needs Lead... Science, and IT teams to ensure a strong data and technology foundation Engage senior leaders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... of uniquely complex issues in a simple and understandable manner to ie team members. Relationships Reports to head of NAO Quality PV Oversight. Maintains positive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …designated programs.Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality ... other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is… more
- Merck & Co. (Rahway, NJ)
- …and Global Regulatory Affairs.--The AVP provides leadership and direction through senior -level and first-line managers and statistical staff focused on end to ... the Oncology therapeutic area. The AVP builds and oversees a statistical team of ~20 employees focused on effective, efficient, and seamless cross-functional… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has ... areas regarding clinical issues related to oncology compounds.-The Executive Director/PDT lead may:-Manage Directors and/or Senior Directors responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability to ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to ... basis. The Senior Director will be accountable for directing a team of pharmacometricians with diverse backgrounds and bringing subject matter expertise related… more
- Merck & Co. (Rahway, NJ)
- …Outcomes Research.Under the guidance of a senior leader, this individual will lead a team of outcomes research professionals to develop value evidence ... agencies, and health systems globally. The ability to successfully participate in and lead cross-functional teams is a critical part of this role. The Executive… more
