Director, Clinical Development (Clinical Trial Physician)

NextCure Inc•Beltsville, MD

2d•Onsite

About The Position

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.

Requirements

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).

Nice To Haves

Demonstrated clinical development and medical monitoring experience attained in a Biotechnology company within knowledge or pre-IND to Phase III monitoring or similar work environment.
Excellent clinical judgement and ability to communicate complex clinical issues to internal and external stakeholders.
Expertise in regulatory submissions including safety and/or monitoring and serious adverse event reporting preferred.
Ability to work on-site in Beltsville, Maryland within a reasonably commutable distance to the office.
History of collaboration both as an individual contributor and on a cross-functional team.
Ability to direct activities while encouraging a positive team-based culture.
Capacity to provide leadership and creativity in the work environment.
Excellent verbal and written communication skills.

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.