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Senior Medical Director, Medical Affairs
Worldwide Clinical TrialsSenior Medical Director managing medical affairs for clinical research at Worldwide Clinical Trials. Collaborating on trial management and supporting business development activities with clinical oversight.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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
Benefits
Comp & perks- Health insurance
- Flexible working hours
- Paid time off
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical monitoringclinical trial managementprotocol designSerious Adverse Events (SAEs) processingclinical study report (CSR) preparationGood Clinical Practices (GCP)regulatory compliancetherapeutic acumenmedical reviewproposal generation
Soft Skills
collaborationleadershipmentoringclient satisfactioncommunicationproblem-solvingintegritywork ethicscompassionorganizational skills
Certifications
medical degree