Associate Director, OED ClinOps Strategic Operations & Learning
AbbVieSouth san franciscoUpdate time: April 18,2022
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. 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. 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 pull through 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: •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 Qualifications: List required and preferred qualifications (up to 10). Include education, skills and experience. Bachelor’s degree (or ex-US equivalent) is required, typically in scientific field. An Associate’s degree/R.N. (or ex-US equivalent) with relevant experience is acceptable 8+ years of experience in the pharmaceutical industry in a variety of roles associated with drug development (research and development, commercial, project management, operations) Minimum of 2 years supporting cross-functional teams in a core function (Program Management, Development, Regulatory, Operations) Demonstrates extensive understanding of adult learning concepts and methodology to effectively identify and lead high performing global teams. Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance). Preferred experience with clinical trial execution, instructional design principles and adult learning tools. Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility, and adaptability to changing requirements. Strong project management experience in the pharmaceutical, biotech or healthcare industry Preferred: Experience with both global and regional teams in the pharmaceutical industry Demonstration of leading teams. PMP, Change management, Lean Six Sigma or process improvement experience desirable Demonstrated proactive and positive team player who is resourceful and creative. Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with experience leading global projects/teams with competing deadlines. Demonstration of successful execution of compliance and training strategy in a fast-paced environment managing multiple priorities effectively using innovative and creative solutions. Significant Work Activities N/A Travel Yes, 10 % of the Time Job Type Experienced Schedule Full-time Job Level Code M 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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