NextCure, Inc. · 1 week ago
Senior Director/Director, Clinical Operations (Global/China)
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
10+ years expNextCure, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of first-in-class immunomedicines for cancer treatment. They are seeking a highly motivated Senior Director/Director of Clinical Operations to manage global relationships and oversee CROs and external vendors, ensuring that clinical trial activities align with operational plans, timelines, and budgets.
BiopharmaBiotechnologyHealth CareOncology
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
Qualification
Required
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
Prior experience in clinical operations within the clinical research industry (biopharmaceuticals/CRO); Prior Oncology experience a plus
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
Preferred
Master's Degree Preferred
Prior Oncology experience a plus
global experience preferred
Company
NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$333.5MKey Investors
Simcere Pharma
2025-11-12Post Ipo Equity· $21.5M
2025-06-16Post Ipo Equity· $2M
2019-11-12Post Ipo Equity· $150M
Leadership Team
Sourav Kundu
Senior Vice President
Recent News
Precedence Research
2025-12-01
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