Director, Clinical Operations

Director, Clinical Operations page is loaded## Director, Clinical Operations locations:
Remote - USAtime type:
Full time posted on:
Posted 30+ Days Agojob requisition :
R-100016
*
* Job Description:

** New Amsterdam is an innovative biotech company with the experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases. Our vision is that people at risk of heart disease can take control of their health and live longer, fuller lives. Our team is led by a world-class team of industry veterans and key opinion leaders, including some of the world’s preeminent cardiometabolic experts and we foster a passionate, supportive culture that is backed by a high level of integrity and inclusivity.

We are seeking an experienced Director of Clinical Operations to join our growing team. In this pivotal role, you will oversee the planning, execution, and management of clinical trials to ensure they meet regulatory requirements, timelines, and quality standards. You will support cross-functional teams, liaise and oversee clinical research organizations (CROs), and ensure that trials are conducted efficiently and ethically while maintaining patient safety.

Reports to:

Executive Director, Clinical Operations.

Location:

East Coast;
Remote position

Key Responsibilities:

• Support the design, planning, initiation, execution, and closeout of global clinical trials.  
• Coordinates clinical trial operational activities to ensure completion according to project timelines and budget  
• Ensure clinical trials are conducted in compliance with New Amsterdam Pharma SOPs, GCP/ICH and any other regulatory requirements and work cooperatively with Quality Assurance with respect to site audits   
• Develop, manage, and review clinical trial documentation, including protocols, informed consent forms, study plans, and reports  
• Ensure the collection, management, and reporting of clinical trial data meets the highest standards of quality.  
• Identify and resolve issues related to trial data, patient recruitment and retention, and site performance  
• Manages clinical trial timelines, enrollment and patient retention objectives, and study budgets in support of trial execution  
• Contributes to the writing and review of key regulatory documents including Investigator Brochures (IB), Annual Reports (AR), INDs and NDAs  
• Coordinates activities with cross-functional teams that include representatives from multiple disciplines (e.g. Regulatory Affairs, CMC, etc.)  
• Works with regulatory affairs to ensure key regulatory documents are maintained and filed in accordance with regulatory requirements  
• Manages and oversight of vendor and CRO activities, and tracks internal and external (CRO/vendor) project deliverables to ensure they remain within the timeline and budget  
• Oversees the construction and maintenance of the trial master file (TMF) with vendors and assure completeness and successful transfer from vendor to New Amsterdam Pharma  
• Stays current with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best practice standards  
• Actively communicates project issues and identifies emerging risks, then works with internal team to resolve challenges  
• Assists in the development of standard operating procedures  
• Remote position US, Northeast based with travel required based on business need Requirements:  
• Bachelor’s degree in a scientific discipline, RN, or equivalent. PMP preferred.  
• 8-10 years Phase 1-3 global clinical trial operations experience  
• Demonstrated experience running sponsor-based late-stage clinical trials required.  
• Experience managing external vendors/CROs required  
• Experience in cardiovascular disease strongly preferred  
• Demonstrated self-discipline, motivation, and entrepreneurial  
• Advanced knowledge of GCP, ICH and FDA regulatory requirements  
• Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision  
•…