Senior Medical Director, Medical Affairs
Worldwide Clinical Trials
Summary
To provide medical management and professional medical support for clinical research projects at WORLDWIDE as the assigned Medical Monitor (MM). To assist in activities requiring Medical & 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.
Job description
Responsibilities
- Medically manages clinical trials to which s/he is assigned as MM
- Serves as Global Lead MM (GLMM) for pan-regional and/or global trial(s) to which s/he is assigned
- Collaborates with the 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 s/he is 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 assist 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, review of relevant therapeutic/clinical literature and attendance in conferences and meetings
- Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through 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 GCPs and regulatory requirements relating to clinical development and safety 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, support 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 WORLDWIDEs electronic safety database
Other Skills and Abilities
- Excellent computer skills (Word, Excel, Access)
- Excellent spoken and written English skills
- Excellent organizational and time management skills
- Excellent communication skills
- Excellent presentation skills
Requirements
- Medical Degree from an accredited institution of Medical Education
- 6-8 years in the CRO, Pharma or Biotech industry with the 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
Benefits
- Competitive benefits package
Company overview
Worldwide Clinical Trials is a leading global contract research organization (CRO) that provides comprehensive clinical development services to pharmaceutical, biotechnology, and medical device companies. Founded with a mission to accelerate the development of innovative therapies, the company offers end-to-end solutions spanning from early-phase research through late-stage clinical trials and regulatory submissions. With expertise across multiple therapeutic areas including oncology, central nervous system disorders, cardiovascular diseases, and rare conditions, Worldwide Clinical Trials leverages its scientific knowledge and operational excellence to design and execute complex clinical studies. The organization maintains a global footprint with operations across North America, Europe, and Asia-Pacific regions, enabling it to conduct multinational trials efficiently. Known for its patient-centric approach and commitment to quality, Worldwide Clinical Trials plays a crucial role in advancing medical research and bringing new treatments to patients worldwide.