Director, Clinical Development Clinical Trial Physician

Benefits

Qualifications

• •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)
• •Qualifications 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
• •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
• •5 more items(s)

Responsibilities

• •and developing first-in-class immunomedicines for the treatment of cancer and other diseases
• •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
• •12 more items(s)