Senior Medical Director, Medical Affairs

Worldwide Clinical Trials•Research Triangle Park, NC

1d•$175,000 - $348,000

About The Position

The Senior Medical Director, Medical Affairs provides medical management and professional medical support for assigned clinical research projects as the Medical Monitor (MM). The role also provides medical and scientific support across feasibility assessments, medical training, clinical input into study protocols and clinical development programs, and business development activities as directed by the department head. The position may serve as Global Lead Medical Monitor for pan-regional or global trials and provides after-hours medical support for assigned projects. The role collaborates with Medical & Safety project teams on serious adverse event processing, supports study documentation and reports, and helps ensure projects meet ethical, legal, regulatory, and GCP standards. It also contributes to business development, client satisfaction, departmental revenue targets, and the mentoring of medical staff. The position requires ongoing therapeutic and clinical knowledge development and competence in medical review using Worldwide’s electronic safety database.

Requirements

Medical degree from an accredited institution of medical education.
6–8 years of experience in the CRO, pharmaceutical, or biotechnology industry in a medical monitoring or study physician role.
Valid passport and ability to travel if required.
Excellent computer skills, including Word, Excel, and Access.
Excellent spoken and written English skills.
Excellent organizational and time-management skills.
Excellent communication skills.
Excellent presentation skills.

Responsibilities

Medically manage assigned clinical trials as the Medical Monitor.
Serve as Global Lead Medical Monitor for assigned pan-regional and/or global trials.
Collaborate with Medical & Safety project team members to process serious adverse events (SAEs).
Provide therapeutic- and protocol-specific training to project teams.
Provide medical input into clinical development programs, study protocols, research papers, and client-focused white papers.
Provide after-hours medical support for assigned projects.
Support business development through proposal generation, feasibility assessments, medical-services proposal and contract review, and sponsor meetings as directed by senior management.
Review and/or assist with preparation of clinical study reports and other study documentation, including protocols and ISS/ISEs, as directed by senior management.
Maintain competence and knowledge of assigned projects, therapeutic and project advances, and marketplace developments through internal meetings, literature review, conferences, and other meetings.
Work with staff in other company functions to support client satisfaction and successful project execution.
Identify, document, and resolve out-of-scope work as directed by senior management.
Assist with annual departmental revenue targets and other activities as directed by senior management.
Maintain working knowledge of GCPs and regulatory requirements and ensure compliance with ethical, legal, and regulatory standards relating to clinical development and safety.
Mentor other medical staff as directed by senior management and model exemplary work ethics, compassion, and integrity.
Maintain clinical and therapeutic expertise in the medical subspecialty through scholarly programs and lectures, online or in person.
Demonstrate competence in SAE-related medical review using Worldwide’s electronic safety database.
Perform other duties as assigned.