- Tris Pharma (Monmouth Junction, NJ)
- …and maintain the GCP QA programs, policies, and SOPs.Ensure GCP compliance of clinical trials .Oversee and manage the qualification and auditing process and other ... and Partners during internal audits and Health Authority inspections.Conducts audits at Clinical trial sites and Contract Research Organizations to ensure the… more
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key...) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … 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
- 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… more
- Merck & Co. (Rahway, NJ)
- …and indication expertise relevant to the asset and uses that to inform trial designs under consideration. Applies criteria to assess unmet medical need and value ... Epidemiology, Pharmaceutical Administration, Public Health, Health Policy, Medicine, or Clinical Pharmacy)5+ years relevant experience following advanced or professional… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring that market access considerations and needs are incorporated into future clinical trials , pre-launch, and commercialization initiatives for inline and ... and inputs to shape Global Market Access / Global HEOR strategies and trial design Ensures alignment on access strategy and key account plans and initiatives… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including evaluation and interpretations of safety and efficacy data generated in the clinical trials and translation of these findings into a benefit-risk ... biotechnology industry experience (including roles in research and development (R&D), clinical trials , regulatory affairs, or medical affairs Leadership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial Management, and Clinical Development. Essential ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Nordisk, Inc. RelationshipsThe fellow will report to the Fellowship Director throughout the two-year program and will also have… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and ... ensure fact-based decisions are generated. Relationships Reports to the Senior Director , Rare Value Communications & Pricing. Interacts internally with team… more
