Clinical Operations Program Lead I, Oncology Early Development - Remote
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.
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 hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) moving into a brand-new site in South San Francisco and focusing 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 AbbVie’s new South San Francisco, CA location or it can be Remote based with quarterly travel to San Francisco.
The Clinical Operations Program Lead I Oncology Early Development will be responsible for;
- Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
- Interacts with and influences all levels of management and cross-functional team members to develop clinical strategies and execute action plans to achieve program objectives.
- Represent Clinical Operations on the Drug Development Teams (Clinical Strategy Team, Asset Development Teams, and Project Safety Teams)
- Responsible for the development of the clinical strategy and plan for execution of clinical studies/programs (ie generation of operational timelines, enrollment models, assessment of availability of the patient population, complexity of trial designs etc)
- Responsible for the development of the costs and timelines for the clinical development programs submitted into the portfolio process
- Responsible for operational decision making, risk mitigation, and contingency planning and operational efficiency and innovation at the program level
- Review and provide clinical operations content to clinical and regulatory documents (IND, IB, NDA, MAA, Regulatory Briefing Books etc)
- Leads cross-functional and within function innovation and process improvement initiatives and ensures effective change management within the organization
- Responsible for developing/managing/mentoring clinical operations staff, including direct supervision of study manager(s), career development of clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed
- Bachelor’s Degree typically in nursing, scientific or equivalent required; Associate’s Degree, R.N., or equivalent with relevant experience is acceptable.
- Must have at least 10 years of Pharma-related/clinical research related experience (and/or applicable work experience).
- At least 6 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical, and leadership competencies through setting and driving study strategy and leading a global team in the management and completion of multiple clinical studies.
- Experience in risk management, decision-making, strategic execution are critical to project and program success and ensuring pipeline decisions can be made on sound data.
- 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 strategies for clinical operations.
- Experience in successful study initiation through study completion, primary data analysis, and/or in multiple phases of studies (Phase1-3, 4).
Significant Work Activities
Yes, 25 % of the Time
Job Level Code
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.