Oncology Clinical Operations Program Lead
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.
Program Lead is a Clinical Operations Director within the Clinical Development Operations (CDO) organization accountable for successful implementation of one or more clinical development programs. A clinical development program consists of all studies for a portfolio asset in a variety of development phases (1-4), indications, and complexity levels. The Program Lead is responsible for 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 the leader of teams responsible for bringing the science embedded in a study protocol to life, the Program Lead 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 to the program. The Program Lead is the single point of accountability within CDO for his/her assigned program.
- Integral member of Integrated Evidence Strategy Team and strategic partner for Asset Strategy Team
- Development of Clinical Operations Strategy for the best path to deliver our medicines to patients and to maximize the value of the asset
- Evaluation of risks and development of mitigation plans across the program in alignment with asset’s strategy
- Interact with and influence all levels of management, stakeholders, and cross-functional team members to achieve program objectives.
- Effectively communicate 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.
- Review and provide clinical operations content to clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books)
- Overall external budget management across their portfolio (programs can be 20-200 million dollars)
- Lead 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.
- Develop, manage and mentor clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership, and direct supervision of 4 – 15 study manager(s) and up to 30 indirect staff
- Create an inclusive, innovative, and learning environment where staff, studies and programs will succeed
- Execute clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures)
- Bachelor’s degree in a life science discipline, or equivalent
- Must have 8-10 years of experience in Pharma/Biotech/CRO planning and executing global clinical trials demonstrating high level of leadership and core technical skills
- Must possess advanced problem solving, critical thinking, and analytical skills
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % 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.