- Legend Biotech USA, Inc. (Piscataway, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team ... cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo...execute experiments, document, and interpret scientific results, present the data to cross-functional teams In vivo study design and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for ... collaboration in cross-functional and multicultural settings including leading implementation of data standards practices within vendor relationships. - Project … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …best practices as well as strong technical skills in working with (clinical) data . The position holder will require strong skills in continuous improvement, ... project management, change management and risk management.Responsibilities ...and translation of business needs to AI/ML tasks, over data understanding and preparation, to modeling, validation and dissemination-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project (s).Strategize and plan for FDA meetings for assigned product. ... within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Review and interpret regulatory guidelinesContinuing Education:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for patients who are likely to benefit from our therapeutics.ResponsibilitiesLeads CDx project teams for the diagnostic, in full alignment with Global Program Teams ... Leads and Regulatory Liasions to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary Position manages the end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs ... development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages ... Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …minutes, and communicate materials, in support of the PSL. Independently evaluates safety data of any source to identify potential safety signals and performs safety ... development of the Safety Management Plan for assigned product(s)Independently evaluates safety data of any source to identify potential safety signals and performs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... of submissions and identify deficiencies against regulatory guidance's or internal data bases.- Facilitate and support liaison activities with functional groups… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities ... TA including at all PMRT meetings and through ad hoc meetings with project owners. Partner with colleagues responsible for PGC medical review to ensure seamless… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... to address prioritization across the portfolio within Oncology/Immuno-OncologyCollaborate with multidisciplinary project teams to develop and apply QSP models to aid… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …handles sensitive documents that may impact multiple Global organizational units or Global project teams. The incumbent may be tasked under the direction of the ... content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate- In collaboration with Head, Global QA Strategy and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Phase 1 studies and multiple dose scenarios, PK/PD M&S analysis data structures and analysis tools requirements, simple disease models, regulatory guidelines ... This position works independently in simpler studies/models and interacts with internal project teams. Responsibilities Analyzes and presents MS Analyses of Phase 1… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …excellence in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex ... procurement for Global RD - for their specific categories.- Data Analysis Based Decision-Making- Uses rigorous analyses of ...Data Analysis Based Decision-Making- Uses rigorous analyses of data as well as market supply base information for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will ... and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is ... oversight and leadership across clinical programs/trials in areas of project management and planning, including related systems/tools, timelines, study metrics,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director FP&A - HQ Finance Transformation The Animal Health Manufacturing (AH MFG) Associate Director - ... financial master data requirements.Provide support to the finance AH MFG Director Actuals COE and team for ad hoc and standardized analysis. This would… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe HR Organizational Readiness, Associate Director is an experienced employee engagement, change management and internal communications ... better inform change and comms plans for HR initiatives.Leverage a data -driven approach/employee listening insights to inform strategies and measure the… more
