NextCure is hiring a Director of Clinical Development with an active MD license to provide medical monitoring inputs. The Director of Clinical Development provides clinical trial inputs as a licensed physician and is located on-site in NextCure's Beltsville, Maryland office.

Company Overview

NextCure is a growing clinical-stage biopharmaceutical company located in Beltsville focused on discovering and developing first-in-class immunomedicines for the treatment of cancer and other diseases. NextCure is committed to professional development in the context of learning, managing, and developing its employees. We create a unique environment for our employees, providing exposure to various facets of our operations cultivating career growth and development. We are excited about the ongoing work at NextCure and invite you to come join us in the culture and build your career in an environment that nurtures professional growth and development.

Job Description

NextCure seeks a Director of Clinical Development to provide medical oversight and clinical leadership for clinical trials with a knowledge of pre-IND requirements through end-of-phase 3 requirements. The Director of Clinical Development will provide clinical inputs and scientific reasoning to ensure safety and efficacy of studies in progress.

The Director, Clinical Development is responsible for ensuring subject safety, data integrity, and protocol compliance across assigned studies. The Director, Clinical Development works collaboratively with cross-functional internal and external teams to support study design, execution, regulatory submissions, and monitoring activities. We seek an individual who thrives in a high-volume, fast-paced, high-performing, and collaborative small corporate environment.

Responsibilities

Monitoring the safety and efficacy of clinical trials and ensuring compliance with protocol and regulatory requirements.Developing and presenting medical monitoring plans. Advising on clinical products, drafting and reviewing key clinical documents from study execution to filing.Acting as the main point of contact for investigators and ensuring the integrity of clinical trial data.Reviewing clinical data, adverse event reports, and making decisions about the continuation or modification of the trial.Collaborating with clinical trial investigators, study coordinators, and other healthcare professionals to ensure the well-being of trial participants.Providing safety oversight and reviewing protocols and products.Excellent communication skills for direct interaction with investigators, regulators, and internal stakeholders.Designing protocols, developing Clinical Development Plans (CDPs), leading interactions with regulators (FDA/EMA), analyzing study data for publications.Required Education and Experience

Medical Doctor (MD or equivalent) degree required; an active MD license with ability to practice in the United States is required.8 years of working experience, preferably a combination of clinical development and medical monitoring experience in a related environment (i.e., biotechnology, pharmacovigilance, medical affairs, regulatory affairs).