Medical Director, Medical Affairs, Americas (US, Canada, LATAM), Gen Med, RARE
Location: Raleigh, North Carolina, United States
Requisition Number: 3626
Position Title: Medical Director, Medical Affairs
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.
Medical monitoring of phase II/III clinical trials and therapeutic expertise in Rare Disease are required. Experience working at a CRO required.
- 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 (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
- 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 Worldwide’s electronic safety database
- 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.
Employment Type: Regular
Community / Marketing Title: Medical Director, Medical Affairs, Americas (US, Canada, LATAM), Gen Med, RARE
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.
Location_formattedLocationLong: King of Prussia, Pennsylvania US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.