Head of Oncology Early Development Clinical Operations
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.
The Head of OED Clinical Operations oversees a cross functional clinical operations study team leaders that are accountable for the strategic and operational design and delivery of all oncology first in human clinical trials up to clinical proof of concept. This candidate will report to the VP and Head of OED and will be a core member of the OED senior staff. S/he will play a critical role in the leadership, evolution, development, and representation of the broader Oncology portfolio, manage a group of clinical study leaders, study managers and actively interface with the post cPOC Development Operations group, Biometrics, OED Clinical, Research, Precision Medicine. This candidate will also be responsible for ensuring enrollment for trials are conducted by AbbVie and for managing CROs. AbbVie conducts oncology first in human clinical trials in North America, Western Europe, Japan & Asia Pacific.
- Provides strategic leadership and direction to the Oncology Early Development first in human clinical trials up to clinical proof of concept.
- Manage a team of ~40 clinical operations study team leaders and managers.
- Establishes an appropriate framework and oversight including input into strategy, prioritization, reviews, and decision making to maximize the probability of achieving the on time and on budget delivery of clinical programs which is an AbbVie top priority and a critical success factor in realizing the LRP. This position is accountable for the on-time and on- budget operational delivery of all of AbbVie’s early-Oncology clinical trials with speed, quality and data integrity.
- Is accountable to inform and execute the OED strategy, enrollment rates and other study enrollment metrics. Active participation in other Oncology specific leadership or governance forums as required.
- Proactively responds to the needs of other functions and influences appropriately to ensure the successful delivery of the portfolio in alignment with the broader Therapeutic Area portfolio strategy. Successful delivery requires establishing strong relationships working in partnership with key stakeholders across Development, R&D, and AbbVie. Seeks alignment within the organization to deliver outputs and achieve the overall strategy.
- Seeks to continually raise the bar for the operationalization of AbbVie oncology study teams, driving both timeline and resource efficiency, partnering cross-functionally for shared learning across the portfolio.
- Will seamlessly manage multiple and competing resource and product streams with a focus on financial health and delivering projects on or under budget. Able to reallocate resources with ease in the face of changing priorities while remaining focused on innovation and streamlining processes.
- Brings a “can-do” attitude while being able to respectfully challenge partners and be assertive when necessary around project timelines, finances, and scope; stretches Development Operations to deliver more, while also serving as a gatekeeper for new initiatives and studies when it comes to feasibility, regulatory issues, and prioritization within overall budget and resource constraints.
- Directly leads the OED Clinical Operations Therapeutic Area Leaders and their teams. Ensures the recruitment and development of the right talent and Oncology therapeutic area expertise to enable the appropriate level of strategic input into clinical program design and clinical study design. Responsible for the growth and development of talent within the Development Operations global organization; for building upon our One Dev Ops and One AbbVie culture; for building a safe and inclusive environment; for building a diverse, high-performing organization.
- Develops and implements strategic vendor selection and management/oversight program for the wide range of vendors that are used in Oncology early development clinical operations. Is accountable for resolving vendor issues that need to be addressed at the executive level.
- Thrives in ambiguity and able to look at processes from an overarching viewpoint to see what can be optimized; prepared to drive that optimization. Drives continual improvement across Development Operations practices, processes and performance to achieve World Class Clinical Execution while driving transformational change to take and keep AbbVie ahead of the competition change early stage oncology to OED or oncology early development clinical operations.
- A minimum of 10 years of bio-pharmaceutical industry experience in a oncology global pharma organization or biotech companies that have delivered oncology medicines.
- A Masters, PhD or Medical Degree with strong oncology background preferred; Bachelor’s Degree in a scientific discipline and extensive previous experience working directly in a oncology first in human clinical research setting is also acceptable.
- Broad knowledge and track record of successfully managing clinical trial operations through all stages of the drug development lifecycle. Knows what can go wrong and how to proactively prepare for all possible outcomes.
- Direct experience in oncology clinical research across early and late-stage programs
- Demonstrated high level of competency in the AbbVie leadership behaviors and ability to work in a matrix environment.
- Big picture and strategic thinker – can formulate a vision of future oncology state and lead the organization to build tactical plans to achieve a robust oncology early development pipeline and create a fast-paced rapid biotech like culture. Experience implementing large-scale change and process improvements relating to medical operations and/or clinical trials.
- Excellent collaborator – easily builds relationships and gains cross functional alignment. Experience with cross-functional leadership and a proven ability to influence and get things done within the intricacies of a highly matrixed organization.
- Excellent business and financial aptitude, very analytical and uses data to drive the business and continuous improvements.
- Experience leading scaled global teams; managing and developing talent; leader of leaders who is able to engage, inspire and align large, diverse teams of seasoned professionals.
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.