- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical ... and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval...KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound, on regular basis ... in collaboration with the study team and outsourcing procurement management . Lead the creation of the CRO scope...or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …etc.) preferred Experience Qualifications- 10+ years of previous experience at senior management level leading quality organization and demonstrated track ... the Oncology and Specialty Medicine portfolios, in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or senior director level, depending on the scope and size of the asset program . This Clinical Science (CS) lead will be responsible for leading and managing ... Reports (CSRs)/outputs throughout the project life cycle. The CS lead will also contribute to the program ...lead will also participate in the creation and management of new clinical science group from existing pool… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety reporting (eg, Periodic ... research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and working closely with the virtual platform vendorProvide weekly dashboard and program metrics to field sales.Vendor Relationship Management :Manage 3rd party ... More Years Pharmaceutical experience required4 or More Years Experience in data analytics/ management preferred, speaker program /peer to peer program … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDescription:The Senior Principal Scientist reports to the Senior Director Chemical Biotechnologies of Process Research & Development Enabling ... of others, and in driving the scientific strategy of the CBT group. The Senior Principal Scientist manages and prioritizes a portfolio of work that includes direct… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This position can be assigned to ... scope change proposals and stage gate proposals for formal presentation to senior management .Is comfortable working independently within a matrix environment and… more
- Merck & Co. (Rahway, NJ)
- …without formal authority; ability to influence and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management , and ... Job DescriptionDevice Development Principal Scientist - Device Development Lead (Director Equivalent) Our company's Device Development (DD) Team designs, develops,… more
- Merck & Co. (Rahway, NJ)
- …or supporting the QP2-I/O Function Lead on oncology development teams.Data management and analysis.On the job, working with senior scientists you will ... join the-Quantitative Pharmacology and Pharmacometrics --Immune/Oncology-(QP2-IO)-team in the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people management , and ... Director, Clinical Operations on plans for successful implementation of studies. Responsible for management of compounds at the program and franchise levels. May… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development ... plans for the Therapeutic Area.- Additional Non-Study related activities: Routine senior management interactions; Influential relationship with top KOLs; Thought… more
- Merck & Co. (Rahway, NJ)
- …Governance Lead collaborates across all levels of the organization, from senior management to tactical execution, to understand information governance needs ... and propose solutions for information governance, data quality, reference data management , data governance and metadata management . Working in a matrixed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple program -level CS Asset ... life cycle is optimized across multiple programsThe CS group lead will also contribute to the program ...to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical Operations, BDM and DLT membersHe/she will… more
- Insmed Incorporated (Bridgewater, NJ)
- …support in medical affairs activities, collaborating closely with Biometrics senior management and key business stakeholders.Provide leadership, guidance ... to the VP of Biometrics presents a unique opportunity to establish and lead a team of statisticians to collaborate closely with the Medical Affairs organization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program medical ... medical readiness activities for market launches and life cycle management for select indications/projects. Gains strategic and planning alignment across… more
- Insmed Incorporated (Bridgewater, NJ)
- …of the pharmaceutical development process from pre-clinical development through life-cycle management and be willing to engage with cross-functional teams seeking to ... techniques in support of preclinical stage small molecule research projects. Lead activities related to analytical testing and method qualification, including… more
- Insmed Incorporated (Bridgewater, NJ)
- …matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall development strategy and ... to contract research organizations. Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on… more
- Merck & Co. (Rahway, NJ)
- …releases are delivered on time, within budget, and with minimal risk.The Release Management Senior Specialist is responsible for the following:Work with various ... located in various geographical locations.Effectively communicate complex issues and challenges to senior management in a summarized manner, both written and… more
