Program Lead I, Oncology Clinical Operations
Clinical Operations at AbbVie conducts/manages clinical trials and provides therapeutically aligned, scientific strategy and operations management for the planning, execution and reporting of clinical development programs to enable successful global registration and commercialization of drug development projects. We are currently growing our Clinical Operations team at AbbVie Stemcentrx, and have a rewarding opportunity for an Program Lead I, Clinical Operations. You will be contributing to developments on the leading edge of cancer research within the pharmaceutical industry and will be part of a nimble, biotech-like environment within a large, well established pharmaceutical company.
Key responsibilities include:
- Provide strategic clinical operations oversight and direction ensuring collaboration across a project(s) to translate our science into reality through high quality clinical trial conduct.
- 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.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- 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.)
- 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.
- 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).
- Ensure effective project or program communications to internal and external stakeholders through meetings, presentations, and other methods.
Qualifications : Basic:
- Bachelor's Degree typically in nursing, scientific or equivalent required; Associate's Degree, R.N., or equivalent with relevant experience is acceptable.
- Must have at least 10 years of Pharma-related/clinical research related experience (and/or applicable work experience).
- At least 6 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical, and leadership competencies through setting and driving study strategy and leading a global team in the management and completion of multiple clinical studies.
- Experience in risk management, decision-making, strategic execution are critical to project and program success and ensuring pipeline decisions can be made on sound data.
- Possesses good communication skills.
- Demonstration of successful coaching, mentoring, and people management (remote management experience preferred).
- Considered a subject matter expert in the application of standard business procedures (International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).
- Integral participation in initiatives or advancement strategies for clinical operations.
- Experience in successful study initiation through study completion, primary data analysis, and/or in multiple phases of studies (Phase1-3, 4).