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.” Theaforementioned job requirements are subject to change to reasonably accommodate qualified disabled individuals.
The BBCIC CSO possesses extensive knowledge of drug surveillance, data models and research networks, electronic health records, epidemiology and statistical methods especially those pertinent to observational research, medical conditions and their treatments, and managed care pharmacy practice; and demonstrates the ability to keep informed of current developments and trends in these fields. Further, the CSO is a recognized thought leader in the research and managed care communities, having extensive publications especially in CER.
Knowledge of appropriate business practices and procedures. Ability to allocate resources, plan and oversee budgets and contracts to ensure fiscal responsibility.
Excellent written and oral communication skills
Ability to communicate ideas, thoughts, and facts in writing and verbally. Expresses ideas clearly and concisely.
Strong attention to detail with ability to prioritize, develop, coordinate and administer multiple research projects to meet the deadlines.
Encourages outreach and dialogue programs, outside opportunities for synergistic and strategic data development and sharing, and invites public deliberation.
Invites deliberation and encourages outside opportunities for synergistic and strategic data development and sharing.
Responsible for hiring principal investigators (PI), delegating tasks and providing constructive feedback. Delegates responsibility, works with and coaches PIs to develop their capabilities. Provides helpful, timely feedback, gives assignments that will help develop their abilities.
Supervises the BBCIC Research Team Coordinator.
EDUCATION AND EXPERIENCE REQUIREMENTS
This position requires doctoral level training in a medical research and/or equivalent training in epidemiology, biostatistics, health services research, or a related field.
Strong knowledge of therapeutics including a clinical degree in pharmacy, medicine, nursing or dentistry is preferred.
Three or more years’ experience as a senior-level researcher with extensive experience conducting and leading observational CER, epidemiologic, and other relevant clinically relevant drug research is required.
Superior knowledge of advanced epidemiology concepts and statistical methods especially in the evaluation of healthcare claims and EMR data.
Professional senior management or executive role experience is required.
Experience leading functionally diverse multi-stakeholder research teams, including mentoring researchers and encouraging consensus from stakeholders
Additional Salary Information: BBCIC offers a competitive salary and an outstanding benefits program including a 401(k) plan; health, dental, and vision insurance; AD&D, short and long-term disability insurance coverage; and free parking. BBCIC is headquartered in Alexandria, VA. To learn more about us please visit www.BBCIC.org.