Director, Clinical Operations, Oncology Early Development
AbbVieSouth san franciscoUpdate time: October 18,2021
Job Description
About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. The Director, Clinical Operations Oncology Early Development (OED), is a key member of the Clinical Operations leadership team responsible for oversight and delivery of clinical trials for the OED portfolio. The Director manages a team of Program Directors and Study Leaders accountable for the strategic and global operational design, planning, and delivery of assets in OED. This Leader will be responsible for identification, planning, and implementation of activities and projects with key strategic importance within OED including implementation of a CRO Partnership Model for one or more CRO partners and oversight of operational strategies and execution for a portfolio of programs. The Director, Clinical Operations will play a critical role in organizational and program leadership representing OED across the broader Abbvie organization. Provides expertise, strategic leadership, and direction to the Oncology Early Development (OED) Clinical Operations organization; an organization responsible for planning and implementation of interventional clinical trials in 25+ countries. Contributes to the establishment of and implements an appropriate framework for oversight including input into strategy, prioritization, resourcing, reviews, and decision making to maximize the probability of achieving the on time and on budget delivery of OED clinical programs. Seeks to continually raise the bar for the operationalization of the AbbVie OED portfolio, driving both timelines and resource efficiency, partnering cross-functionally and with CRO partners to ensure shared-learning is applied across the portfolio Is accountable to inform and execute on the OED Clinical Operations strategy, actively participating in OED leadership and governance forums as required. Brings a “can-do” attitude while being able to respectfully challenge partners and be assertive when necessary with project timelines, finances, scope, and project complexity. Key contributor to the portfolio planning process including responsibility for the development of costs, resource projections and timelines for the clinical development programs under consideration. Successfully establishes strong relationships, working in partnership with and influences all levels of management and cross-functional team members to achieve program objectives: scope of influence extends across OED and AbbVie, including Regulatory Affairs, Medical Writing, QA, CMC, Precision Medicine, and Therapeutic Area Medical Directors. Serves as a leader for transformational projects with large organizational impact and ensures effective change management across the cross-functional areas that support clinical program execution. Develops and implements strategic vendor and partner selection. Accountable for resolving vendor issues that need to be addressed at the Sr Management level. Responsible for developing, managing, mentoring clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership and direct supervision of ~3-6 Clinical Operations Director/Associate Program Directors and ~12 Study Leaders, career development of clinical operations staff and creating an inclusive, innovative and learning environment where staff and studies/programs will succeed. Responsible for executing clinical programs in a dynamic environment ensuring compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures) Qualifications Bachelor’s degree in a life sciences or medical field, required. Advanced degree (Master’s, PhD, MD) preferred. Must have at least 12-14 years of pharma-related/clinical research experience At least 8 years in clinical research demonstrating a high level of cire, technical and leadership competencies through setting and driving operational strategy and leading global teams. Experience in risk management, decision making, and strategic execution are critical to success in this role, ensuring that pipeline decisions can be made based on sound data Demonstration of successful coaching, mentoring, and people management (remote management experience preferred) Considered a subject matter expert in the application of standard business procedures (ICH, Global Regulations, Ethics and Compliance) Experience leading initiatives or advancement of strategies for clinical operations Experience in successful study initiation through study completion, primary data analysis and in multiple phases of studies (Phase 1 – 3) Experience leading Clinical Operations strategy and delivery in early oncology setting highly preferred Significant Work Activities N/A Travel Yes, 25 % of the Time Job Type Experienced Schedule Full-time Job Level Code D Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
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