Vice President Clinical Development
Company: NextCure Inc
Posted on: September 25, 2022
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
- Discuss study design with investigators and key opinion
- 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
- Inform Clinical Development team of changes in the
efficacy/safety and/or risk benefit profiles of products if and as
- 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
- Assist with field site questions during conduct of trials as
- Evaluate safety enquiries and data from clinical trials in real
- 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.
- 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
- 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
- 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
- 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.
Keywords: NextCure Inc, Baltimore , Vice President Clinical Development, Other , Beltsville, Maryland
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