- Daiichi Sankyo, Inc. (Bernards, NJ)
- …early clinical safety for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director , Clinical Safety, will be a product safety lead or part ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in ... projects concurrently are crucial for this role. Advanced knowledge of Data Management , Biostatistics, Clinical Operations, Pharmacovigilance, handling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Director , Clinical Development Join a Legacy...Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assignment and oversight of the group. This position reports to the Associate Director Data Management Operations. Business administration activities within ... rare diseases and immune disorders. Job Summary: The Manager, Clinical Data Repository Administration is a member...response & management ; knowledge of industry standard clinical technologies including, EDC, Clinical Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting will drive ... creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global Oncology...Integrate with the Global Marketing teams and provide a data driven point of view for inline and pipeline… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …brands. Additionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management , IIS programs ... Affairs activities including strategy, communications, and medical affairs directed clinical activities across the oncology portfolio. The position has leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non-compliance such as: different approaches to data review in conjunction with Data Management and Clinical Science, audit trail review for non-logical ... achieve a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct....CSM to improve quality and ensure patient safety and data quality and integrity.Establish, measure, analyze and report on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assessments of scientific and therapeutic hypotheses, as well as preclinical and clinical data . preferredAbility to drive projects to deliver timely results ... feasibility analysis. Prepare documents for submission and presentation to management . Report to global business development leadership and cross-functional senior… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Data Management (CDM) serves as Therapeutic Area Head providing Clinical Data Management leadership to Data ... support of Regeneron key development programs. Works with Sr Director and Executive Director to set department...Manager (CCDM) experience. + Minimum of 12+ years of clinical data management experience in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for ... Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with… more
- Bristol Myers Squibb (Madison, NJ)
- …to the sustainability and success of the BMS R&D pipeline. This role reports to the Director , Clinical Data Management or Associate Director , ... and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager, Clinical Data Management ( Data Management Lead) is a… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment as ... to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review + Conducts clinical data review per Integrated Data Review Plan (IDRP) + ... ** Director , Clinical Development** **Join a Legacy...(MM): + Provides oversight to the CRO MM for clinical data review activities + May support… more
- Sanofi Group (Bridgewater, NJ)
- …problem solving skills. + Understand and keep updated with the pre- clinical , clinical pharmacology and clinical data relevant to the molecule of ... **Job Title** : Clinical Research Director **Location:** Cambridge, MA...drug safety, marketing. + Advance the CDP through internal management review. + Leads a clinical subteam… more
- Lilly (Branchburg, NJ)
- …(CT) Supply Chain Associate Director will provide operational leadership of clinical supply chain data , systems, and processes to drive operational ... assess, mitigate risk, and perform portfolio analyses through robust data and metrics analysis. o Lead and ensure operational...chain, health care or scientific field. o Experience with clinical supply demand management tools (such as… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** **Associate Director , Clinical Pharmacology - Virology** **_*This is a site-based ... cross-functional study team. + With input from others, designs clinical pharmacology study protocols, study data analysis,... pharmacology input into or otherwise authors study documentation, data analysis / management plans and scientific… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Director of Clinical Pharmacology will provide expertise and support to internal ... clinical pharmacology function in cross-functional project teams including Project Management , CMC, Analytical Sciences, Nonclinical, Clinical Operations, … more
