Senior Medical Director, Medical Affairs

Worldwide Clinical Trials • Austin, TX

1d

About The Position

The Senior Medical Director, Medical Affairs will provide medical management and professional medical support for clinical research projects at Worldwide Clinical Trials as the assigned Medical Monitor (MM). This role assists in activities requiring medical and scientific support, including but not limited to assistance with feasibility assessments, medical training, and provision of medical/clinical input to the design of study protocols and/or clinical development programs, as well as assistance with business development activities, as directed by the department head.

Requirements

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

Responsibilities

• Medically manages clinical trials to which they are assigned as MM
• Serves as Global Lead MM (GLMM) for pan-regional and/or global trials to which they are assigned
• Collaborates with other members of the Medical & Safety project team to process Serious Adverse Events (SAEs)
• Provides therapeutic and protocol-specific training to the project teams
• Contributes medical input into the design of clinical development programs, study protocols, research papers, client-focused white papers, etc.
• Provides after-hours medical support for projects to which they are assigned
• Independently supports Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors as directed by department senior management
• Reviews and/or assists in the preparation of final study reports (CSRs) or other study documentation (protocols, ISS/ISEs, etc.) as directed by senior management
• Maintains a high level of competence with assigned projects, including knowledge of project and therapeutic advances as well as marketplace developments by participating in internal meetings (company-wide project tracking, medical management meetings, etc.), reviewing relevant therapeutic/clinical literature, and attending conferences and meetings
• Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through the successful execution of projects
• Identifies, documents, and appropriately resolves out-of-scope work as directed by senior management
• Assists in the annual attainment of departmental revenue targets and any other activities as directed by senior management
• Maintains working knowledge of Good Clinical Practices (GCPs) and regulatory requirements relating to clinical development and safety to assure compliance with ethical, legal, and regulatory standards
• Mentors other medical staff as directed by senior management and, by consistently displaying exemplary work ethics, compassion, and integrity, supports senior management’s leadership of both the department and the company
• Maintains clinical/therapeutic acumen in medical subspecialty through online and/or in-person scholarly programs/lectures
• Demonstrates competence with the execution of SAE-related medical review in Worldwide Clinical Trials’ electronic safety database
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior