The Area Head, Clinical Site Management - Americas (CSM) within Clinical Development Operations oversees an Area organization of approximately 500 employees / contractor operating in in all countries within the respective Area with responsibility for the on time, within budget and on quality delivery of AbbVie’s Clinical Research pipeline [a small number of studies will be outsourced to CROs] to the highest levels of performance with operational excellence.
•Provides strategic leadership and direction to the respective Area (Clinical Site Management organization - Americas), which includes our team of Clinical Research Associates, Area Leadership, Area Site Management Leaders, Area Study Start-up and Country study start up to ensure the on time and within budget delivery of clinical research programs, regulatory submissions, and successful regulatory inspections across all therapeutic areas.
• Provides appropriate strategic framework, oversight, and operational flexibility to ensure the on time and on budget delivery of clinical programs which is an AbbVie enterprise level priority and CEO imperative as well as a critical success factor in realizing the LRP. This position is accountable for operationalization and execution of clinical trials within and across all respective countries while ensuring quality and integrity of clinical data to support subsequent Marketing Authorization Applications globally.
• Based within an AbbVie Hub Office Location (Headquarters in Lake County, IL USA). Works in partnership with peer senior leaders in Development, Medical Affairs and other functions across R&D and the broader company; partnering within the affiliates with Medical Director and General Manager One R&D Community to ensure successful delivery of the CSM strategy.
•Establishes the optimal geographic operational footprint for CSM to deliver the studies required by the clinical development plan and in line with AbbVie corporate strategy.
•Provides strategic direction into the planning for determining timelines and budgets for global clinical studies; as well as into the short- and long-range resource planning/models, staffing, and budgeting to meet the needs of Development.
• Manages the organization like a business. Accountable for driving continuous improvement to achieve global operational excellence and cost-effective clinical trials compared to alternative operational models;
• Maintains a working knowledge of current industry practices and future trends, as well as global regulations and requirements governing the clinical trial business; Participates in industry leading groups, such as TransCelerate / Linking Leaders, and other external leadership forums to advocate AbbVie’s position and drive industry level change in the conduct of clinical trials; Ensures that AbbVie is on the forefront of driving the change.
•Ensures organization is operating in compliance with ICH GCP Guidelines, AbbVie Quality System and local and worldwide regulatory (GCP, Ethics, Financial, Customs, Trade etc) requirements.
•Provides strategic direction and ensures oversight and operational excellence of the global contract management organization; works in partnership with Legal, Outsourcing, affiliate Finance to ensure that contracting is not on the critical path for startup of clinical trials.
•Provides strategic direction and ensures the highest possible ethical standards are applied and quality is maintained across the portfolio. Works in partnership with key stakeholders, include Clinical, Safety, and Data Sciences, within the centralized data review framework, processes and systems, to ensure, in part, patient safety and integrity of data at investigator sites
•Responsible for people growth and development within own organization, as well as the broader Development Operations organization.
- Minimum Bachelor’s degree with 15 years pharma-related/clinical research related experience, Advanced degree with 12 years.
- Demonstrated successful experience with leading through transformational change, global department building, setting, and driving study strategy and leading a global team.
- Thorough knowledge of the clinical drug development process and on market Medical Affairs, and experience across phases of clinical development.
- Big picture and strategic thinker – can formulate a vision of future state and lead the organization to build tactical plans to achieve this.
- Excellent collaborator – easily builds relationships and gains cross functional alignment.
- Robust business and financial aptitude, very analytical and uses data to drive the business and continuous improvements.
- Articulate communicator with “Executive Presence”
Clinical Development Operations Differentiating Behaviors
Mission-oriented/Leads with Integrity
Keeps the mission and strategy of AbbVie at the front of mind in all their activities. Recognizes that the ultimate goal is to get life-altering drugs in the hands of patients who need them most and is able to see how their role fits into that larger vision. Keeps patient safety, data integrity, and medical/inspection standards at the forefront when executing and planning for future and ongoing operations.
Thrives in ambiguity and able to look at processes from an overarching viewpoint to see what can be optimized; prepared to drive that optimization. Able to make decisions without complete information. Takes the long view as projects ae not measured in months but years. Able to learn from mistakes and “fail fast” while maintaining a positive mindset in leading the team. Continuously scans the environment for technologies and approaches which expand AbbVie’s capacity to deliver clinical trials and potentially accelerate the time to market. Allocates resources efficiently (e.g., uses technology to accomplish tasks formerly performed by humans) to drive competitive advantage and thinks beyond the status quo to foster innovation.
Challenge the Status Quo/Ensure Feasibility
Brings a “can-do” attitude while being able to challenge partners and be assertive, when necessary, around project timelines, finances, and scope; stretches development clinical development operations to deliver more, while also serving as the gatekeeper for new initiatives and studies when it comes to feasibility, regulatory issues, and prioritization within overall budget and resource constraints.
Seamlessly manages multiple and competing resources and product streams with a focus on financial health and delivering projects on or under budget. Able to allocate resources with ease in the face of changing priorities. Willing to focus on innovation and streamlining processes as well as “doing more with less”.
Proactively responds to the needs of others and makes their own needs and business strategy known. Works across the organization with leadership to fully integrate the Development Operations function with key stakeholders, including but not limited to, Discovery, Commercial, Search and Evaluation, Finance, GMA and within Clinical Development. Seeks alignment within the organization in order to deliver outputs and achieve overall strategy. Externally approaches stakeholders with customer service orientation in order to be perceived as a clinical study partner of choice.
Expert Communicator/Talent Leader
Able to translate difficult concepts into actionable, simplified steps and deliver information in a succinct and digestible manner to colleagues at all levels. Focused on minimizing confusion between groups working on the science itself and those in commercial roles; able to flex communication skills across a matrixed organization. Gives guidance and inspiration to their direct reports and teammates. Engenders trust throughout the organization and seeks to grow and stretch key talent for future possibilities.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.