The AMCP BBCIC, a multi-stakeholder research collaborative, is seeking a Chief Science Officer (CSO) with extensive experience in drug surveillance and observational research methods. The BBCIC is a science-based, non-profit, public service initiative that will monitor biosimilars and their corresponding novel biologics for effectiveness and safety. The research draws on a distributed research network (DRN) with de-identified medical, pharmacy and EMR data covering 100 million people. The BBCIC framework applies the same scientific, analytic methods used by the FDA Sentinel initiative, a post-market surveillance system that harnesses cutting-edge distributed research network and surveillance methods to track the safety of pharmaceuticals and other therapies once they reach the market
The BBCIC Chief Science Officer has responsibility for leading and developing the BBCIC surveillance research in compliance with the BBCIC Charter and Policies and Procedures. This includes working in conjunction with all BBCIC Participant organizations, the BBCIC Coordinating Center and data partners, surveillance and outcomes researchers, and other surveillance organizations including the U.S. FDA.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Responsible for the BBCIC conduct of observational CER for biosimilars and biologics, including assessment and modeling of DRN data as it pertains to development of protocols. This includes providing scientific oversight for clinical, data, epidemiology, research methods, and data utility insight and support to BBCIC Science Committee and Research Teams.
- Manages the recruitment of world-class researchers and clinicians for the multidisciplinary BBCIC research teams appointed by the BBCIC to conduct research. Convenes, supports, and works closely with the BBCIC Science Committee and Research Teams which include scientists, clinicians, observational data experts, patients, and other stakeholders to prioritize research topics and methods and to develop rigorous comparative effectiveness research (CER) specifications.
- Responsible for capacity building and growth of all aspects of the BBCIC observational research data infrastructure (BBCIC DRN) and the engagement and collaboration of BBCIC and synergistic stakeholders in these processes.
- Works in conjunction with BBCIC Participant Organizations to disseminate BBCIC research findings and represent the BBCIC externally through coalitions, agencies, associations and alliances and serves as the primary point of contact for the BBCIC research effort including serving as the official spokesperson on research findings.
OTHER DUTIES AND RESPONSIBILITIES
- Collaborates with BBCIC’s Program Director in evaluating and improving the processes used by BBCIC to engage stakeholders
- In conjunction with Program Director, leads or supports proposal development and initiatives that leverage and enhance BBCIC’s research environment.
- In conjunction with Program Director, supports development BBCIC conferences and webinars.
- Participate in strategic planning and its implementation for the BBCIC.
- Other duties and projects as assigned
The AMCP BBCIC reserves the right to modify, interpret, or apply this job description in anyway the association desires. This job description in no way implies that these are the only duties, including essential duties, to be performed by the employee occupying this position. This job description is not an employment contract, implied or otherwise. The employment relationship remains “at-will.” The aforementioned job requirements are subject to change to reasonably accommodate qualified disabled individuals.