- Merck & Co. (Rahway, NJ)
- …including clinical directors and study managers to lead/support clinical trial scientific activities.Job ResponsibilitiesResponsible for the clinical ... /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving ... investigational compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage...strategies;Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology… more
- Merck & Co. (Rahway, NJ)
- …Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisionsCollaborate with other functional areas,… more
- Merck & Co. (Rahway, NJ)
- …of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document disclosure, and data sharing with ... external researchers. The Executive Director in Medical Writing will... in Medical Writing will be responsible for overseeing clinical trial data registration, results postings, redaction… more
- Merck & Co. (Rahway, NJ)
- …facility with the capability to manufacture supplies for early and late phase clinical trials .- Close partnership with supply chain colleagues from Quality, ... provides a launch pad for the commercial formulation development and GMP clinical supply manufacture of our company's drug product pipeline.- The FLEx Non-Sterile… more
- Merck & Co. (Rahway, NJ)
- …or more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials , clinical trial design and Go/No Go decisionsServe as a ... advanced pharmacometrics capabilities like comparator modeling, model-based meta-analysis (MBMA) and clinical trial simulations (CTS) into programs and thereby… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck & Co. (Rahway, NJ)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high-quality clinical trial protocols, review of clinical data and Clinical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical... Director level for each respective program. This Clinical Science (CS) Group Lead will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Position Summary / Objective: Serves as a primary ... source of medical accountability and oversight for one or more clinical trials . Matrix management responsibilities across the internal and external network.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Position Summary / Objective Serves as a primary ... source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sciences, Global Clinical Operations, Biostats and Data Management and Clinical Development.Responsibilities:Designs and leads clinical trial sample ... regulatory submission or associated drug regulatory submissionsResponsible for implementation of clinical trial assays at Diagnostics Partners, reference labs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non- clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for the ... CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in clinical trials required.Demonstrated ability to define clear clinical trial translational strategies anchored in disease biology and drug mechanism ... enumerate key translational hypothesis that will drive scientific decision-making both from non- clinical and clinical translational aspects. In doing so, he or… more
