Medical Director, Medical Monitor, Medical Affairs, Endocrinology; Rare, Americas (US, Canada, LATAM) Remote
Location: San Francisco, California, United States
Requisition Number: 3790
Position Title: Senior Medical Director, Medical Affairs
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 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.
- 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 teams 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
- As directed 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 (company-wide project tracking, medical management meeting, etc), 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
- Assists in the mentoring of 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 WORLDWIDEs electronic safety database
- Medical Degree from an accredited institution of Medical Education.
- Oncology Specialty
- At least 2 years of medical monitoring in clinical research or related industry
- Valid passport and ability to travel as required.
Employment Type: Regular
Community / Marketing Title: Medical Director, Medical Monitor, Medical Affairs, Endocrinology; Rare, Americas (US, Canada, LATAM) Remote
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.