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Legend Biotech Corp.
, NJ, United States
Legend Biotech is seeking Director, Clinical Operations as part of the Clinical Operations team based in Somerset, NJ. Role Overview The Director, Clinical Operations is responsible for leading the planning and management and oversight of the Legend Biotech pipeline studies. The Director, Clinical Operations will be responsible for all aspe
Job Source: Legend Biotech Corp.Legend Biotech US
Somerset, NJ, United States
Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural k
Job Source: Legend Biotech USLegend Biotech
Trenton, NJ, United States
Legend Biotech is seeking Director, Clinical Operations as part of the Clinical Operations team based in Somerset, NJ. Role Overview The Director, Clinical Operations is responsible for leading the planning and management and oversight of the Legend Biotech pipeline studies. The Director, Clinical Operations will be responsible for all aspec
Job Source: Legend BiotechJohnson & Johnson
New Brunswick, NJ, United States
DePuy Synthes , part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical a
Job Source: Johnson & JohnsonJ&J Family of Companies
New Brunswick
Director Clinical Operations DPS - 2406189771W **Description** Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovativ
Job Source: J&J Family of CompaniesJ&J Family of Companies
New Brunswick, NJ, United States
Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ) J&J Family of Companies Director Clinical Operations DPS in New Brunswick , New Jersey Director Clinical Operations DPS - 2406189771W Descripti
Job Source: J&J Family of CompaniesDaiichi Sankyo
, NJ, United States
Associate Director, Global Clinical Operations in Remote at Daiichi Sankyo Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our w
Job Source: Daiichi SankyoMerck
Trenton
**Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific
Job Source: MerckPrinceton, NJ, United States
The Director, Clinical Operations will provide operational and implementation expertise to the project teams under the guidance of the Chief Medical Officer. He or she will lead activities associated with the evaluation, initiation, and management of clinical studies ensuring compliance, managing timelines, budgets and review of all clinical data. The Director, Clinical Operations will serve as the primary contact for the contract research organizations (CROs), laboratory vendors and clinical sites involved in the clinical trials. The Director will need to execute effectively as a member of a cross-functional team, leveraging colleagues from many functions in the company, influencing and leading all clinical operations outcomes. The right candidate willhave the depth of clinical research experience and regulatory knowledge necessary to make independent operational decisions and be comfortable in executing daily operational tasks.
JOB RESPONSIBILITIES
Oversight of clinical trial site management in conjunction with selected CRO and CRA’s, oversight of clinical trial site monitoring and source documentation verification
Development of in-house operations SOPs, guidelines and systems
Lead development and maintain departmental/clinical trial budget
Assist the Chief Medical Officer in protocol design and provide advice on logistical issues
Input/prepare patient informed consent document (ICDs)
Ensure timelines and milestones relating to the clinical trial are being met including but not limited to site activations, enrollment, first patient in, last patient last visit, and reviews for data safety monitoring boards and data monitoring committees.
Preparation and updates of Investigational Drug Brochures (IBs)
Preparation and management of clinical trial site budgets
Preparation of regulatory documents including INDs, IND annual updates, briefing documents, CTAs, and regulatory meeting briefing documents as requested
Guide clinical trial report preparation and data interpretation
Preparation of Investigator Alert letters and SAE reports as required and ensure reporting timelines are met
JOB REQUIREMENTS
Bachelor’s degree in a scientific discipline; advanced degree preferred.
8 or more years of drug development experience, at least 4 of which in clinical operations in a pharmaceutical or biotech company
4 or more years of oncology drug experience
2 or more years immunotherapy experience
Strong working knowledge of the drug development process, with experience in clinical studies from Phase 1 to Phase 3
In-depth knowledge of ICH/GCP guidelines and FDA regulations.
Ability to work independently
Excellent oral and written communication skills
Travel requirements – international, approximately 20-25%
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Email Alert for Director, Clinical Operations jobs in Princeton, NJ, United States
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