Director, OED ClinOps Strategic Operations & Learning
AbbVieSouth san franciscoUpdate time: April 27,2022
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. Description - External Since 2013, AbbVie has expanded its commitment to the San Francisco Bay Area with the consolidation of three Bay Area facilities to a new Bay Area headquarters in South San Francisco. AbbVie employees in the Bay Area drive AbbVie’s research-based, innovation driven missions in healthcare. Specifically, Bay Area employees bring deep scientific expertise and commercial excellence to advance cancer care. Current oncology areas of focus include immuno-oncology, tumor targeting, tumor dependency and precision medicine. With facilities positioned in the heart of the biotechnology industry, we are able to collaborate with the best and brightest minds in oncology. The Director, OED ClinOps Strategic Operations & Learning is responsible to connect science and operations to bring clinical studies to life through the execution of multiple high-priority strategic projects. Responsible for development of the program strategy to ensure quality and efficient, on-time, within budget delivery. Serves as a strategic advocate for OED and provides strategic thinking, a global mindset, and innovative solutions to address risks and challenges. This leader will bring expertise in adult learning and process/program management to be a critical partner for on the Oncology Early Development (OED) Clinical Operations (ClinOps) team. This role will support the organization to enable scaling and maintaining an effective operating model built around strategic CRO-partnerships. This person will lead the design and build of impactful learning programs that foster compliance and performance excellence in global clinical trial execution. This person will also partner with the ClinOps Leadership Team to follow through on operational updates in a global, complex, cross-functional environment to achieve functional effectiveness and provide tactical input to support the scalability and sustainability of the OED operating model. Responsibilities: Strategic Operations •Integral member of the Clinical Operations Leadership Team and a strategic partner to the head of OED ClinOps whose remit is to build and maintain a high functioning organization and operating model •In alignment with Clinical Operations Priorities, develops and delivers roadmap of strategic operations projects •Responsible for the programmatic evaluation of risks and mitigations to achieving the delivery of key strategy operations projects. •Interacts with and influences all levels of management and cross-functional team members to achieve objectives: primary scope of influence is within OED, cross-functional colleagues who support clinical trial execution and CRO engagement •Leads large scoped, cross-functional innovation and process improvement initiatives with significant business impacts and ensures effective change management across the cross-functional areas that support clinical program execution. •Drives initiatives across a program of high-priority projects designed to build a scalable and sustainable operating model. This role will be integral in setting and ensuring alignment across key activities in OED ClinOps •Partners with the ClinOps Leadership Team, effectively translating strategy into operational process and practice that inspires and empowers stakeholders to achieve excellence. •Manages and oversees operational projects that are cross-functional, highly complex, and are of high priority for the organization •Develops and assesses integrated project plans, resource projections, risk plans, and effectiveness metrics •Accountable for helping teams navigate the change management process effectively and efficiently •Responsible for problem solving, risk mitigation and contingency plans at a global level •Leads or participates in global, cross-functional initiatives/teams in support of business priorities. •Actively shares learning and collaborates with ClinOps Leaders to apply best practices to supported projects Represents and communicates the vision and priorities of OED ClinOps Leadership with relevant stakeholders across the organization Technical Learning •Manages the development, implementation, and maintenance of ClinOps global learning programs supporting strategic operational objectives. •Establishes and executes the continuous learning strategy in alignment with business goals, portfolio prioritization, and ClinOps Leadership while adhering to global Regulatory requirements. •Directs or provides leadership to ensure processes, courses and curricula are aligned with the strategic objectives of the ClinOps organization. •Owns and evaluates the process used to assess new and revised documents (e.g., SOPs, work instructions) to ensure accurate and compliant learning assignments. Ensure periodic review of learning programs and content for accuracy and relevancy in alignment to compliance requirements. Responsible to understand AbbVie's Quality System, GCP, BPO framework and portfolio priorities and translate to learning programs and teams as appropriate. •Represents ClinOps Technical Learning during regulatory inspections, audits, and process improvement initiatives. •Collaborates closely with AbbVie and industry curricula leaders to ensure alignment, determine future focus, and share best practices. Develops learning material to support the technical execution of studies within the OED operating model. Qualifications •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) •At least 8 years (and/or applicable work experience) in clinical research and/or learning demonstrating a high level of core, technical, and leadership competencies through setting and driving strategy and leading the management and completion of multiple projects. •Possesses good communication skills. •Demonstration of successful coaching, mentoring, and people management (remote management experience preferred). •Experienced in the application of standard business procedures (International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance). •Integral participation in initiatives or advancement of strategies for clinical operations. Significant Work Activities N/A Travel Yes, 10 % 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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