AbbVie Associate Director, Oncology Clinical Operations in South San Francisco, California
O ncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position is based at Stemcentrx, AbbVie's South San Francisco, CA location.
Associate Director/Program Lead II - 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 Associate Director, 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.
Bachelor’s degree or equivalent is required, typically in nursing or scientific field. An Associate’s degree/R.N. or equivalent with relevant experience is acceptable.
Must have 12 years of Pharma-related/ clinical research related experience (and/or applicable work experience).
Must have 8 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical and leadership competencies through setting and driving strategy.
Proven ability in leading a global team in the management and completion of multiple, complex clinical studies.
Ability to demonstrate successful coaching/ mentoring and people management (remote management experience preferred).
Expertise in Subject Matter and competent in application of standard business procedures (SOPs, 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 in multiple phases of studies (Phase 1-3, 4).
Must possess good communication skills.
Key Leadership Competencies:
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Learns, fast, grasps the 'essence' and can change the course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-California-South San Francisco
Organization: Research & Development
Travel: Yes, 10 % of the Time
Req ID: 1608205
Equal Opportunity Employer Minorities/Women/Veterans/Disabled