Vice President Clinical Development

Company: NextCure Inc
Location: Beltsville
Posted on: September 25, 2022

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
                            • MD with 6-12 years' clinical development experience in the pharmaceutical or biotechnology industry and relevant therapeutic specialty experience in Oncology; board certification or eligibility in Oncology with an emphasis in solid tumors is desirable.
                              • Experience with clinical phase I-III of pharmaceutical or biotech product clinical testing, with experience involving solid tumors a plus.
                                • Experience implementing and complying with clinical and regulatory guidelines that include IND/NDH, GCP/ICH and their equivalent.
                                  • Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts.
                                    • Strong written and verbal communication skills (fluency in written and verbal English) as well as proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
                                      • Strong work ethic with expectation of excellence from self and others. Must have high personal credibility and outstanding written communication skills.
                                        • Adaptable, flexible, independent, and resourceful with ability to roll up sleeves and multi-task in order to thrive and lead in smaller and growing company environments.
                                          • Self-starter who works with a sense of urgency and functions as a strong team player, effectively working with other disciplines.
                                            • Interest in future career growth and executive leadership opportunities as the company expands.
                                            • Previous work history within a similar biotechnology and/or product development company as an Executive Medical Director, Vice President and/or Executive medical position highly desirable.
                                            • Large and small company experience preferred.
                                              • Willingness to travel as needed to support a variety of Company initiatives. NextCure, Inc. offers a competitive salary and benefits package in a scientifically engaged teamwork environment. NextCure, Inc. is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics. PI191799875

Keywords: NextCure Inc, Baltimore , Vice President Clinical Development, Other , Beltsville, Maryland