Associate Director of Global Registry Programs and Medical Operations (Medical Affairs)
Job Title: Associate Director of Global Registry Programs and Medical Operations (Medical Affairs)
Date Available: Immediately
Location: Lexington, Massachusetts
Due to low awareness of LAL Deficiency within the healthcare community, a disease registry is an important longitudinal database that will complement our on-going clinical development program, sebelipase alfa, and help to answer the un-answered questions about the disorder.
The Associate Director, Global Registry Programs (Medical Affairs), will lead and manage the strategic and operational aspects of the LAL Deficiency disease registry (and future registries if applicable) in collaboration with a governing medical advisory board.
- Project Vendor and Budget Management
- Establish the strategic and tactical objectives of the project
- Identify and recruit sites
- Protocol and Case Report Form (CRF) revisions
- Develop and implement a plan for transfer of data from Synageva’s Natural History Studies into the LAL Deficiency Registry
- Work effectively with registry vendor teams
- Manage the vendor to ensure key milestones are met
- Manage the project to ensure the budget is maintained and funded within the established timelines based on key milestones
- Registry Advisory Board development, communication and coordination
- Ensure that the RAB recognizes Synageva’s priorities while maintaining independence with respect to scientific direction
- Coordinate and facilitate RAB meetings
- Coordinate and facilitate Registry meetings (regional, global as necessary)
- Hiring and management of contractors and FTEs
- Provide training, support and guidance
- Development of a training curriculum for internal and external stakeholders
- Type of training (e.g., web-based, live, etc)
- Development of materials
- Execution of training
Establish a process for effective and timely communication to/with internal and external stakeholders
- Registry updates, meetings, milestones, etc.
- Develop and manage a process that ensures timely and consistent enrollment and training of participating registry centers
- Develop a plan and key performance indicators to ensure timelines are followed with regards to data collection at the level of each participating center
- Develop a monitoring system to ensure timely and consistent resolution to requests and input by participating centers and to continuously improve the quality of data entered into the registry
- Best practices
- Maintain current on the utilization of data from disease registries for regulatory purposes (e.g., BLA and MAA filings, post-approval commitments) and provide recommendations to the senior leadership team on how to adapt the registry to ensure alignment
- This role will also be responsible for the organization of past, current, and emerging medical and scientific literature for Synageva’s research and development programs (primarily, sebelipase alfa for LAL Deficiency and SBC-103 for Sanfilippo B). This will require the management and oversight of the central search engine vendor with the ultimate goal of simplifying internal access to, and analysis of, the literature.
Job Requirements and Qualifications:
The ideal candidate will have a solid background in clinical development/operations within the biotechnology or pharmaceutical industry and direct experience in project management.
− BA/BS required
− 5 - 7 years of project management experience
− Understanding of clinical trials, registries and related clinical site management activities
− Understanding of clinical development and operations
− Understanding of information technology (e.g., Electronic Data Capture systems) and on-line data reporting tools
− Excellent verbal and written communication skills
− Ability to meet or exceed project timelines without sacrificing quality
− Ability to adapt to a dynamic work environment
− Advanced degrees (MS, MPH, PhD)
− Post-marketing clinical trial experience
− Management of medical and scientific literature
− Hands-on experience managing a disease registry utilizing EDC tools
− 3-5 years of site management experience
− Ability to work independently with minimal supervision
The position will be based in Lexington, Massachusetts and will report to the Vice President of Medical Operations. Domestic and international travel will be required (–up to 10%).