Director, Clinical Operations
3 weeks ago
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%
#J-18808-Ljbffr
-
Director, Clinical Operations
5 days ago
Princeton, United States Sun Pharma (Taro Pharma) Full timeDirector, Clinical Operations/CPM Sun Pharma Advanced Research Company, Limited Summary The Director, Clinical Operations/CPM is responsible for the development of a Clinical Operations Team in the United States. Work with Function Head in Resource planning and assignments across studies. Responsibilities Assigned: Team Mentoring, Motivating,...
-
Associate Director, Clinical Operations
1 month ago
Princeton, United States Sun Pharmaceutical Industries Full timeAssociate Director, Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. This is a hybrid role and based in...
-
Associate Director, Clinical Operations
2 weeks ago
Princeton, United States Sun Pharmaceutical Industries Full timeAssociate Director, Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. This is a hybrid role and based in...
-
Associate Director, Clinical Operations
4 weeks ago
Princeton, United States Sun Pharmaceutical Industries Full timeAssociate Director, Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. This is a hybrid role and based in...
-
Associate Director, Clinical Operations
5 days ago
Princeton, United States Sun Pharma (Taro Pharma) Full timeAssociate Director, Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. This is a hybrid role and based...
-
Director, Clinical Operations
5 days ago
Princeton, NJ, United States Sun Pharma (Taro Pharma) Full timeDirector, Clinical Operations/CPM Sun Pharma Advanced Research Company, Limited Summary The Director, Clinical Operations/CPM is responsible for the development of a Clinical Operations Team in the United States. Work with Function Head in Resource planning and assignments across studies. Responsibilities Assigned: Team Mentoring, Motivating,...
-
Director, Project Management
3 weeks ago
Princeton, United States WCG Clinical Full timeLocation 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 ) Director, Project Management (Remote) General Information Location: Princeton, NJ, Remote Organization: Medavante-Prophase, Inc Job Type: Full Time -...
-
Senior Director Project Management
3 weeks ago
Princeton, United States WCG Clinical Full timeSenior Director Project Management (Remote) General Information Location: Princeton, NJ, Remote Organization: Medavante-Prophase, Inc Job Type: Full Time - Regular Description and Requirements ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate...
-
Princeton, United States ACADIA Pharmaceuticals Inc. Full timePlease note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. The Sr. Director, Vendor Management, DEI & FSP Operations plays a strategic and operational leadership role in delivering clinical trial services to the Clinical Operations organization. As a member of the...
-
Princeton, United States ACADIA Pharmaceuticals Inc. Full timePlease note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. The Sr. Director, Vendor Management, DEI & FSP Operations plays a strategic and operational leadership role in delivering clinical trial services to the Clinical Operations organization. As a member of the...
-
Clinical Director-RN
3 weeks ago
Princeton, United States LHC Group Full timeSummary We are hiring for a Clinical Director-RN with a minimum of two years Director or above experience in Princeton, West Virginia. At PCH Home Health, a part of LHC Group, we embrace a culture of caring, belonging, and trust and enjoy the meaningful connections that come from it: for the whole patient, their families, each other, and the...
-
Clinical Director
6 days ago
Princeton, United States The Living Room at Princeton Full time**Job description** **Overview**:The Living Room is a private substance abuse treatment provider offering Partial Hospitalization (PHP), Intensive Outpatient (IOP), and Outpatient (OP) levels of care. The Living Room is a compassion-based model of recovery. We offer our clients the opportunity to experience a level of understanding and heart-felt care that...
-
Princeton, United States WCG Clinical Full timeABOUT WCG: WCG's clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to...
-
Princeton, United States WCG Clinical Full timeABOUT WCG: WCG's clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to...
-
Associate Director, Clinical Operations
5 days ago
Princeton, NJ, United States Sun Pharma (Taro Pharma) Full timeAssociate Director, Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey Summary The Associate Director, Clinical Operations is responsible for Oversight of the Project Management team, Clinical Research Associates, Clinical Trial Associates as well as motivating, mentoring and training. This is a hybrid role and based...
-
Director Clinical Research
1 month ago
Princeton, United States System One Holdings, LLC Full timeTitle: Director of Clinical Research Location: Must be local Princeton, NJ Type: Perm Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring a Director of Clinical Research w/ 10+ years industry experience. If you want to be a part of this groundbreaking work, please apply! Prefer a Rare Disease background but not required Must have...
-
Director Clinical Research
1 week ago
Princeton, United States System One Holdings, LLC Full timeTitle: Director of Clinical Research Location: Must be local Princeton, NJ Type: Perm Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring a Director of Clinical Research w/ 10+ years industry experience. If you want to be a part of this groundbreaking work, please apply! Prefer a Rare Disease background but not required Must have...
-
Director Clinical Research
3 weeks ago
Princeton, United States System One Full timeTitle: Director of Clinical Research Location: Must be local Princeton, NJ Type: Perm Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring a Director of Clinical Research w/ 10+ years industry experience. If you want to be a part of this groundbreaking work, please apply! + Prefer a Rare Disease background but not...
-
Director Clinical Research
1 week ago
Princeton, United States System One Full timeTitle: Director of Clinical Research Location: Must be local Princeton, NJ Type: Perm Start Date: ASAP Leading Pharmaceutical Company located in NJ is hiring a Director of Clinical Research w/ 10+ years industry experience. If you want to be a part of this groundbreaking work, please apply! + Prefer a Rare Disease background but not...
-
Executive Clinical Director
3 weeks ago
Princeton, United States Forge Health Full timeAbout Us:Forge Health is a mission-driven outpatient mental health and substance use provider dedicated to providing the highest quality, affordable, and effective "one-stop-shop" care to individuals, families, and communities in need. As the first and only behavioral healthcare provider with a proven, national payer-validated ability to drive clinical...
