- Merck & Co. (Rahway, NJ)
- … supply chain across the full Company's Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, ... internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings .- Working independently, the Program CSPM… more
- Merck & Co. (North Wales, PA)
- …Documentation, Clinical Investigations, Clinical Judgment, Clinical Reporting, Clinical Research, Clinical Trial Documentation, Clinical ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical...the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of… 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 ... study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and… more
- Merck & Co. (North Wales, PA)
- …planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial Team lead . Leads and directs teams in key study ... (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management… more
- Genmab (NJ)
- …as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for ... immune disorders. Summary: Provide leadership and guidance as the lead statistician dedicated to safety on one or more...and characterization for ongoing studies and compound level pooled clinical trial data of project(s). Act as… more
- Merck & Co. (San Francisco, CA)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas....seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions… more
- Merck & Co. (San Francisco, CA)
- …Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills:Budget Development, Business, Clinical Supply Chain Management, Clinical ... data-driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt Lead , the Associate Director, DSCS Digital Project Manager, will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after… more
- Formation Bio (New York, NY)
- …in program execution, ensuring the team stays at the forefront of innovation in clinical trial operations. About You You're excited about the intersection of AI ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Eisai, Inc (Nutley, NJ)
- …and soft-skills training (eg medical insights workshops, presentation skills, understanding clinical trial design, statistics, etc.) to supplement MSL ... difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the… more
- Merck & Co. (North Wales, PA)
- …decision-making skills, expertise in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience in ... including regulatory submissionsDemonstrated history of development and execution of innovative clinical trial designs and exploration of novel analysis methods… more
- Protara Therapeutics, Inc. (New York, NY)
- …choline needs via oral or enteral routes. Job Overview: The Clinical Trial Manager (CTM)/ Clinical Research Associate is responsible for providing ... oversight of the Sponsor's outsourced Contracted Research Organizations (CRO) clinical trial services, with a primary focus... services, with a primary focus on ensuring quality Clinical Research Associate (CRA) monitoring and data… more
- Nurix (San Francisco, CA)
- … Clinical Operations, Clinical Development, Medical Affairs, Regulatory Affairs, Clinical Trial Sites and laboratories. This role may have future ... deficiencies to senior management, as appropriate Act as the lead Clinical Quality assurance point of contact...and procedures accordingly. Accountable for the QA review of clinical trial documentation and documents submitted to… more
- Regeneron Pharmaceuticals, Inc. (Tarrytown, NY)
- …internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, ... The Associate Manager, Clinical Drug Supply &...orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely… more
- Revolution Medicines (Redwood City, CA)
- …and technical documents, including but not limited to: clinical label text, clinical /master batch record, clinical trial protocol, pharmacy manual, IND, ... to support RevMed's clinical development programs. Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan.… more
- DermBiont (Emeryville, CA)
- …in support of preclinical studies and clinical trials. Audit and review clinical trial documents, reconcile audit results from multiple sources, and maintain ... Organization: DermBiont is a clinical stage biotech company with multiple active INDs...Assuming positive results in the current trials the two lead products will advance to Phase 3 trials in… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …aligned medical communications plans; adjust communications plans in accordance with clinical trial results/milestones and changes in the healthcare landscape ... Publication Professional (CMPP), and ISMPP active member highly desired Understanding of clinical trial design and execution, statistical methods and clinical… more
- BioSpace (South San Francisco, CA)
- …Completion of a subspecialty fellowship is desirable. At least 3 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent. ... trials or research activities of one or more clinical development programs. Participates in and may lead...PD modelling for dose optimization also valued. Knowledge of clinical trial methodology, regulatory and compliance requirements… more
- Fortrea (Dallas, TX)
- …interactions, etc.). Other key responsibilities : Provide high standard of care for clinical trial participants, utilizing nursing diagnosis and clinical ... We are currently seeking a Research Nurse , to lead and support our Clinical Pharmacology Start-up...Forms. Other duties as assigned. YOU NEED TO BRING Associate 's Degree or BS degree in nursing with current… more
