Title: ASSOCIATE DIRECTOR CLINICAL OPERATIONS PROGRAM LEAD
Location: USA-Illinois-Lake County
Job Number: 13000001FB
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
PRIMARY JOB FUNCTION:
Provides strategic clinical operations oversight and direction ensuring collaboration across a project(s) to translate our science into reality through high quality clinical trial conduct.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Ensure the activities that impact one or more projects are executed according to the clinical development plan.
• Develop and execute program-specific project and risk management plans (milestones, metrics, critical path) ensuring and appropriate escalation as needed
• Set program-level enrollment strategy including country and site selection plan and timelines to meet program objectives
• Ensure program-level Investigational Product supply strategy meets the needs of the clinical program (s)
• Oversee the strategic selection of program-wide vendors
• Develop and assess cost and resource projections of program for portfolio plan and business development opportunities and serve as point of contact
• Represent the clinical operations program on strategic governance bodies (e.g., Product Safety Team, Global Project Team, etc.)
• Co-lead Clinical Sub Team with Therapeutic Area representative
Ensure effective project or program communications to internal and external stakeholders through meetings, presentations, and other methods
• Ensure consistency and compliance across all studies within a program
• Partner with Quality Assurance to develop the strategic plan for regulatory audits and inspections
• Evaluate study-level issues for broader impact (e.g., cross-study, etc.) in a timely fashion and ensure resolution.
• Key contributor to a project or program documents (e.g. Investigator’s Brochure (IB), DSUR, PSUR, regulatory submissions)
• Represent the clinical operations function at advisories, interactions with regulatory agencies and evaluation of business opportunities (due diligence)
• Participate in resource prioritization across teams to ensure clinical operations strategic goals and milestones are achieved
• Management and development of direct reports
• Matrix management of a team of clinical operations personnel assigned to plan, implement and execute clinical trials
POSITION ACCOUNTABILITY / SCOPE:
• Strategic planning and execution of a project(s) in collaboration with the therapeutic area and relevant groups.
• Effective clinical operations oversight to ensure on time delivery of project(s) within the pipeline
• Core member of strategic governance body (e.g., GPT), interacts with all functions supporting clinical development.
• Responsible for developing and managing project budget (typically up to $500MM).
• Bachelor's degree or equivalent is required, preferably in a scientific field. Advanced degree is desirable.
• Must have 10 years of clinical research experience
• Experience in setting and driving strategy and leading a team in the management and completion of clinical studies
• Demonstrated strong leadership competencies in a matrix environment in a clinical study leadership role
• Demonstrated people management skills
• Global experience in clinical research preferred
• Demonstrated experience in managing multiple or complex projects
• Participation in a regulatory submission is preferred
• Considered SME for SOPs, initiatives and advancement of clinical operations as an organization
Job: CLINICAL RESEARCH