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Vice President Clinical Development

NextCure Inc
Beltsville, MD
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
NextCure is a publicly traded (NASDAQ: NXTC) 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, providing exposure to various facets of our operations cultivating career growth and development.

POSITION OVERVIEW

The Vice President Clinical Development is a key member of the clinical team and will report directly to the Chief Medical Officer. Under the supervision of the Chief Medical Officer, the Vice President Clinical Development utilizes their therapeutic knowledge of oncology and solid tumors and/or related expertise to plan and execute study design protocol development, implementation, and monitoring of the company’s Phase I-III Oncology/Hematology clinical trials. The position will provide clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the department and the company to regulatory standards and procedures. A proven ability to work with and communicate with peers across all areas of the business is essential. An interest in growing beyond the Vice President role in the future is also desired. Being resourceful, working hands-on in an environment that values team work and being able to thrive in a small company environment are key attributes for this position.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Assist in or design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents.
  • Discuss study design with investigators and key opinion leaders.
  • Provide clinical input for clinical protocol monitoring guidelines and analysis plans.
  • Drive clinical interpretation of study data. Review and evaluate emerging efficacy safety data of drugs in on-going clinical trials.
  • Inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles of products if and as they occur.
  • Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams, and labeling).
  • Lead or assist in the development of publications - abstracts, manuscripts, slides, etc.
  • In collaboration with team members (e.g., Clinical Operations, Data Management) assist in identifying / evaluating / monitoring vendors, monitoring clinical trial conduct/status.
  • Assist in database finalization, reviews of study results, results interpretation and CSR’s.
  • Assist in planning and conducting investigator meetings and Advisory Boards.
  • Assist with field site questions during conduct of trials as needed.
  • Evaluate safety enquiries and data from clinical trials in real time.
  • Present interim and final study results, as appropriate, to company, investigators, and/or medical/scientific community.
  • Other Corporate Initiatives: Assist with key marketing and communication initiatives and perform other duties as assigned.

QUALIFICATIONS

NextCure Inc

Address

Beltsville, MD
20705 USA

Industry

Business