China)

NextCure Inc•Beltsville, MD

2d•Onsite

About The Position

NextCure is a clinical-stage biopharmaceutical company located in Beltsville, Maryland, focused on the discovery and development of first-in-class immunomedicines for the treatment of cancer and other diseases. We are committed to professional development in the context of learning, managing, and developing our employees. We create a unique environment for our employees, providing exposure to various facets of our operations to cultivate interdisciplinary career growth and development. We are seeking a highly motivated Senior Director/Director of Clinical Operations to provide input on the overall operational plans across programs including management and coordination of global relationships, including our China-based partnership. The Senior Director/Director of Clinical Operations will manage CROs and external vendors to ensure timelines and budgets align. The candidate must thrive and adapt to a fast-paced, innovative, and changing environment. This role is preferred to be located on-site in the Beltsville, Maryland office with the potential for Remote dependent upon qualifications. JOB SUMMARY The Director of Clinical Operations provides input on the overall operational plans across all programs. The role will include oversight of CROs and external vendors to ensure timelines and budgets align within programs.

Requirements

Bachelor's Degree in Sciences, Nursing, or a related field
Minimum of 10 years of work experience in clinical operations within the clinical research industry (biopharmaceuticals/CRO) to qualify for Director.
12 or greater years of relevant work experience in global clinical operation leadership roles, including work history of direct management of global partnerships required to qualify for Senior Director
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience along with a working knowledge of drug development
Experience managing and overseeing CROs and Partnerships; global experience preferred
Strong leadership, communication, and organization skills
Exceptional ability to plan, organize and conduct clinical studies with minimum oversight
Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)
Ability and willingness to travel up to 10% annually is required
Oral and Written fluency in English

Nice To Haves

Master’s Degree Preferred
Prior Oncology experience a plus

Responsibilities

Serve as primary lead for one or more global clinical trial(s) across therapeutic program/portfolio, including management and coordination of communications with NextCure's partner based in China.
Ensure conduct of clinical trial activities in accordance with Standard Operating Procedures, ICH/GCP, and all applicable regulations governing the conduct of clinical trials.
Deliver trial(s) on time, within budget, and with highest achievable quality.
Function as primary liaison for internal stakeholders and vendors, as appropriate.
Assists in the review, development and/or writing of clinical trial documents and manuals, required to execute the trial(s).
Contribute to study forecasting and tracking of enrollment, investigational drug, and financials.
Review/develop recruitment plans, risk-mitigation plan, monitor and implement contingencies as required.
Prepare reports to update management on conduct of trial(s).
Monitor, review, and summarize clinical trial data for ongoing studies.
Participate in preparation of regulatory filings (e.g. IND, pre-IND, etc.).
Prepare RFPs, oversee selection, and effectively lead the management of clinical study vendors and their deliverables including: CRO(s), Central Lab(s), Drug Depot(s), and other external service providers.
Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work.
Attend, participate in, and conduct meetings and training with internal and external collaborators as needed.
Ensure completeness of Trial Master File (TMF) and various tracking systems for assigned studies.
Participate in the preparation and follow-up of internal process audits, vendor and study site quality audits, as well as regulatory authority inspections.