Clinical Operations Program Lead (Director Level)

• Represent Clinical Operations on the Drug Development Teams (Clinical Strategy Team, Asset Development Teams, and Project Safety Teams) for programs in the Neuroscience therapeutic area
• 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 or equivalent is required, typically in nursing or scientific field. An Associate’s degree/R.N. or equivalent with relevant experience is acceptable.
• Must have 12+ years of Pharma-related/ clinical research related experience (and/or applicable work experience)
• Must have 8 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical and leadership competencies through setting and driving strategy
• Proven ability in leading a global team in the management and completion of multiple, complex clinical studies
• Ability to demonstrate successful coaching/ mentoring and people management (remote management experience preferred)
• Expertise in Subject Matter and competent in application of standard business procedures (SOPs, 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 in multiple phases of studies (Phase 1-3, 4)
• Must possess good communication skills

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.