Director of Clinical Operations

1 month ago

Beltsville, United States NextCure Inc Full time
Job DescriptionJob Description

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 Director of Clinical Operations to provide input on the overall operational plans across programs. The 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.

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.

REQUIRED SKILLS & ABILITIES

  • Accountable to deliver trial(s) on time, within budget, and with highest achievable quality.
  • Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
  • Provide expertise for all aspects of clinical operations across all clinical trials, including coordination of associated cross-functional disciplines.
  • Lead internal budget, resource, and timeline management across Clinical Operations department.
  • Assist with strategic program planning consistent with departmental and corporate objectives and priorities resulting in optimized operation performance and efficiency.
  • Support authoring clinical protocols, investigator brochures, informed consent forms, annual reports, clinical study reports, and clinical documents required to execute the trial(s).
  • Participate in preparation of regulatory filings (e.g. IND, pre-IND.).
  • Prepare for and oversee delivery of data outputs of ongoing clinical trials, for key disclosures including Dose Escalation and Safety Cohort Review Meetings, Annual Safety Reports/DSURs, Scientific Committee Abstracts and Presentations
  • Prepare RFPs, oversee selection, and effectively lead the management of clinical study vendors including: CRO(s), Central Lab(s), Drug Depot(s), and other external service providers.
  • Ensure appropriate clinical trial plans are implemented and managed.
  • Present progress reports/updates to executive management.
  • As needed, assist in preparation of presentations for quarterly board meetings and directly interact with board members to support efforts in clinical.
  • Develop and implement department SOPs, training, on-boarding plans, and clinical systems for Clinical Operations.
  • Function as the primary liaison for internal stakeholders and vendors, as appropriate.
  • Attend, participate in, and conduct meetings and training with internal and external collaborators as needed.
  • Lead the preparation and follow-up of internal process audits, vendor and study site quality audits, as well as regulatory authority inspections.

REQUIRED EXPERIENCE

  • Minimum of 8 years of experience in clinical operations within the clinical research industry (biopharmaceuticals/CRO)
  • Prior Oncology Drug Development experience is a plus
  • Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience
  • Demonstrated understanding of the biotech/pharma industry and therapeutic product development
  • Outstanding project management and organizational skills and ability to multitask and perform in a fast-paced entrepreneurial and growing environment
  • Demonstrated leadership capabilities with ability to work independently to complete projects on time and within scope
  • Strong analytical, problem solving, critical thinking, organizational and planning skills
  • Excellent communication, negotiation and interpersonal skills
  • Proficiency in Microsoft Office Products including Word, Excel, PowerPoint, SharePoint)
  • Knowledge of electronic systems including CTMS, EDC and eTMF
  • Ability and willingness to travel up to 10% annually is required, both domestic and internationally
  • Oral and Written fluency in English

REQUIRED EDUCATION

  • Bachelor's Degree in Sciences, Nursing, or a related field
  • Master’s Degree in a related field Preferred

NextCure, Inc. is committed to equal opportunity and affirmative action in employment. The company ensures non-discrimination in all its employment practices. Every qualified applicant is considered for employment without attention to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, status as a protected veteran, genetic information, age, or any other characteristic protected by law.

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