- Merck & Co. (Rahway, NJ)
- …at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director ... continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision and/or lead… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description Director -QP2-IO We are seeking an experienced talented scientist to join the - Quantitative Pharmacology and Pharmacometrics - - ... Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global Clinical Development organization and has oversight over drug… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or ... span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical development and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving ... Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and ... development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of highly… more
- Merck & Co. (Rahway, NJ)
- …pharmacodynamic endpoints/platforms, and early phase vaccine trials.Reporting to the Executive Director and Head of TMS (in EDS/BARDS), the incumbent will manage ... and its applications in clinical drug development. Primary Activities :Report to the Executive Director and Head of TMS (in EDS/BARDS).Serve as a member of the EDS… more
- Merck & Co. (Rahway, NJ)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business… 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 and ... in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design . Lead the team to define Critical to Quality factors, select critical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for ... to access for patients across our portfolio of products. The Associate Director will develop, in partnership with other key stakeholders, innovative solutions for… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...including, but not limited to dose selection, clinical trial design , and go/no-go decisions. Represent QP2 on cardiometabolic and… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Director , Quantitative Systems Pharmacology (QSP) . QP2-IO team is part of the ... of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative,… more
- Merck & Co. (Rahway, NJ)
- …stakeholders on matters related to privacy compliance, including privacy by design , Privacy Impact Assessments, Data Protection Impact Assessments, and adherence to ... our Policies, Rulebook Standards, and Specifications.Monitor the evolving global regulatory landscape, including tracking and analyzing new data protection laws, assessing potential impact to ensure timely adaptation of existing business practices, and… 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 ... data and programming standards; emerging data capabilities and methods. Implements quality-by- design approaches to confirm the quality, integrity, and fit-for-use of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Job SummaryThis role is responsible for design and overseeing, coordinating, and managing activities related to the ongoing ... as Global Technical Owner for the relevant area.ResponsibilitiesResponsible for the design , configuration, customizing and further development of the relevant SAP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pipeline for critical rolesProvides expert advice and support for organization design and change management to business leadersIdentifies, analyzes issues and ... opportunities which are within established policies and procedures and engages stakeholders to gain alignment and endorsement of solutions.Builds the Daiichi Sankyo workforce plan to increase the skills, engagement and productivity of the workforce to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the effective strategy, design , execution, and interpretation of Oncology clinical trials. Position...provide clinical input into the eCRF (Case Report Form) design , participate in the UAT (User Acceptance Testing) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates ... as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for robust R&D data management processes (including but not limited to CRF/eCRF design , all steps from database development to database release, data review and ... cleaning, database lock), to ensure data quality/integrity and regulatory complianceEnsures that Data Management Plans are consistent and regulatory compliant across studies and programs.Promotes Risk Based approaches to data cleaning and reviewProactively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 plan, and ... achieving planned forecast spend, including but not limited to managing healthcare databases of claims and electronic health records data, vendors, and ensuring compliance to contractual terms and data security requirements.- Develop, review, and contribute… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level. Responsible for clinical program planning and execution (from study design , operational planning, start-up, conduct, reporting, and close out) including ... Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies.… more
