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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.

Director, Clinical Operations Program Leader, Oncology Early Development

South San Francisco, California Req ID 2207504 Category Research and Development Division AbbVie
  • 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.

    Oncology 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 early development pipeline.  More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these sites. They combine their expertise in small molecules, 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.  

    The Clinical Operations Program Leader (COPL) is a Clinical Operations Associate Director/Director within Oncology Early Development (OED), Clinical Operations organization accountable for successful implementation of one or more clinical development programs for high visibility assets or a large, complex asset or number of assets with smaller programs or multiple indications. The COPL is responsible for development of the clinical operations strategy and for the efficient and on-time delivery of all clinical studies within the program(s) at highest level of quality in alignment with company goals and objectives. As a leader of teams responsible for bringing the science embedded in a study protocol to life, the COPL must display leadership qualities and apply operational know-how, scientific expertise, strategic thinking, analytical skills, global mindset, and innovative solutions to anticipate challenges and proactively manage the risks of the program. The COPL is the single point of accountability within OED for his/her assigned programs. The COPL is also a strategic people leader responsible for developing a pipeline of talents for the OED Clinical Operations organization.  

    Responsibilities:

    •Integral member of the Asset Strategy Team whose remit is to maximize the value of our assets and portfolio for patients and AbbVie.

    •Responsible for development of the clinical operational strategy and is responsible for the execution of clinical studies/programs (e.g., generation of operational timelines, enrollment options, assessment of availability of the patient population, balancing complexity of trial designs vs speed)
    •Responsible for evaluation of risks and develops mitigation plans across the program in alignment with the asset strategy. Identifies strategic options for the Asset Strategy Team to evaluate in the face of competing priorities, interests or unanticipated challenges.

    •Provides disease area expertise and input to the function and the TA while anticipating changes in the disease landscape (e.g., standards of care) and regulations that impact operational strategies

    •Provides strategic oversight of CRO partners, creating strong external relationships to ensure quality and timely delivery of outsourced programs.
    •Interacts with and influences all levels of management, stakeholders across OED and AbbVie more broadly, and cross-functional team members to achieve program objectives.
    •Effectively communicates program status and progress to stakeholders, senior management, and governance bodies.

    •Key contributor to the portfolio planning process including responsibility for the development of the costs, resource projections and timelines for the clinical development programs under consideration.
    •Reviews and provides clinical operations content to clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books)
    •Responsible for overall external budget management across their portfolio (programs can be 20-200 million dollars)
    •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.
    •Responsible for hiring, developing, managing, mentoring clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership and direct supervision of 4 – 15  study manager(s), 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 compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).


  • Qualifications:

    •Bachelor’s degree or equivalent is required, in a scientific or healthcare discipline is preferred. Master’s or advanced degree (e.g., MS, MPH, MD, PhD) is a plus.

    •Must have 12+ years of Pharma-related/ clinical research related experience (and/or applicable work experience) including 8-10 years of experience in Pharma/Biotech/CRO planning and executing global clinical trials demonstrating high level of leadership and core technical skills.

    •Experience in risk management, decision-making, strategic execution is critical to project and program success and ensuring pipeline decisions can be made on sound data.
    •Must possess advanced problem solving, critical thinking, and analytical skills

    •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 of strategies for clinical operations.

Significant Work Activities: N/A
Travel: No
Job Type: Experienced
Schedule: Full-time
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