The AMCP BBCIC, a multi-stakeholder research collaborative, is seeking a Program Director (PD) 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 PD has responsibility for leading and developing the BBCIC program 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 design, development, implementation and growth of all aspects of the BBCIC and a broader managed care pharmacy research utility, with biosimilars being the first generation activity and second generation utilities to include such areas as guidelines monitoring. •Responsible for managing the BBCIC governance structure including the BOMD, Planning Board, Science Committee, Research Teams, Communications Committee and Coordinating Center. Ensure ongoing communication, consultation and collaboration among the Committees and ad-hoc working groups and compliance among BBCIC Participants with adopted policies and strategies. •Fundraising for BBCIC Participants, research contracts and grants. •Fiscal management including working with the financial services provided by AMCP to oversee financial management, budget preparations and presentation of budget to the Planning Board and ultimately to the Board of Managing Directors for approval •Responsible for BBCIC contract management including developing and monitoring compliance with agreements between the BBCIC and its partners and vendors. Includes managing external consultants including the Coordinating Center and data partners. •Works in conjunction with BBCIC Participant Organizations in representing the BBCIC externally through coalitions, agencies, associations and alliances and serves as the primary point of contact for the BBCIC including serving as the official spokesperson and coordinating external communications. Coordinates with CSO on dissemination of BBCIC research findings.
Assists Chief Science Officer (CSO) with; •Managing the recruitment of world-class researchers and clinicians for the BBCIC research teams. •Supporting Science Committee and research teams in developing rigorous comparative effectiveness research (CER) protocols and specifications. •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. •Providing clinical, data and research utility issue insight and support to BBCIC Participants and Committees based on professional experience and expertise in health care, research and managed care pharmacy practice
Other Duties and Responsibilities: •Provide input for discussions and manage preparation of materials for BBCIC boards, committees and research teams. •Develop BBCIC conferences and webinars. •Leads strategic planning and its implementation for the BBCIC. •Other duties and projects as assigned.
SUPERVISORY RESPONSIBILITES: Delegates responsibility, works with and coaches staff to develop their capabilities. Provides helpful, timely feedback, gives assignments that will help develop their abilities. Responsible for hiring staff, delegating tasks, conducting performance appraisals and providing constructive feedback.
Supervises the BBCIC Chief Science Officer.
SKILLS AND ABILITIES REQUIRED:
Job Knowledge The BBCIC Program Director possesses extensive clinical knowledge as well as 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 PD is a recognized thought leader in managed care communities.
Budgetary Responsibilities 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.
Project Management •Ability to develop, coordinate and administer tasks, projects and activities to meet the deadlines. •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.
EDUCATION AND EXPERIENCE REQUIREMENTS: This position requires doctoral level clinical training (PharmD, MD). Training in medical research and/or equivalent training in epidemiology, biostatistics, health services research, or a related field is desired. •Strong knowledge of clinical therapeutics. •Three or more years’ experience evaluating treatment options or participating in clinically relevant drug research is required. •Knowledge of epidemiology concepts and statistical methods especially in its application to the creation and evaluation of published research. •Experience leading functionally diverse multi-stakeholder teams, including mentoring and encouraging consensus from stakeholders.
WORKING AT AMCP BBCIC In addition to a dynamic work environment, 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.
Working Conditions Offering the flexibility to be remotely based anywhere in the U.S.
Travel Moderate overnight travel, up to 15% by land and/or air.
Please apply at the AMCP career center link below.
It is the policy of AMCP to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AMCP will provide reasonable accommodations for qualified individuals with disabilities