Clinical Operations Program Director [China]

 

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The Clinical Operations Program Director is responsible to connect science and operations to bring clinical studies to life through the execution of multiple clinical research programs for high visibility assets or a large, complex asset or number of assets with smaller programs or multiple indications within an asset. Responsible for the development of the clinical operational strategy and to ensure clinical research programs are executed with quality and efficiency, on-time, within budget, and to meet company objectives. The Clinical Operations Program Director serves as a strategic advocate for pipeline assets and provides operational reality to our scientific experiments, clinical operations and scientific expertise, strategic thinking, a global mindset and innovative solutions to address risks and challenges. The Clinical Operations Program Director also serves as a strategic people leader responsible for attracting, developing and retaining a pipeline of talent for the Development Operations organization and will play a key leadership role within the affiliate for Clinical Study Leadership, working with a One R&D and global mindset.

• Integral member of the Pipeline Commercialization Model’s Integrated Evidence Strategy Team (IEST) and a strategic partner for the Asset Strategy Team (AST) and Development Review Committee whose remit is to maximize the value of our assets and portfolio for patients and AbbVie. Partner and support in a hybrid manner, other Clinical Operations Program Directors leading their assets in order to strategically partner with IEST and AST teams.

• In alignment with the asset’s strategy and incorporating the science and the operations, develops or partners to develop the clinical operational strategy and is responsible for the execution of clinical studies/programs (e.g., generation of operational timelines, enrollment options, assessment of availability of the patient population, balancing complexity of trial designs vs speed)

• Responsible for the programmatic evaluation of risks and mitigations to achieving the asset strategy. Identifies strategic options for the Asset Strategy Team to evaluate in the face of competing priorities, interests or unanticipated challenges.

• Interacts with and influences all levels of management (globally, regionally and locally) and cross-functional team members to achieve program objectives: primary scope of influence is within Development Operations, cross-functional colleagues who support clinical trial execution, the Development and Global Medical Affairs Therapeutic Area MDs/SDs, and local affiliate leadership & stakeholders.

• Supports the Clinical Study Leadership Team [i.e. VPs, and Therapeutic Area Head(s) in applicable TAs where interventional clinical studies planned/conducted] to drive and influence regional strategy and operational execution of the broader Therapeutic Areas. Successful delivery requires establishing strong relationships working in partnership with key stakeholders across Development, R&D, and AbbVie, both locally as well as regionally/globally.

• 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.

• Reviews and provides clinical operations content to clinical and regulatory documents (e.g., INDs, IB, NDAs, BLAs, MAA, Regulatory Briefing Books)

• Responsible for overall external budget management across their portfolio

• Leads 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.

• Responsible for hiring, developing, managing, mentoring clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership and direct and indirect supervision of staff, career development of clinical operations staff and creating an inclusive, innovative and learning environment where staff and studies/programs will succeed

• Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures and applicable local requirements)

• 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)

• At least 8 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical, and leadership competencies and behaviours through setting and driving study strategy and leading a global team in the management and completion of multiple clinical studies.

• Considered a subject matter expert in the application of standard business procedures (International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance) with application in the China local setting and solid understating of local requirements

• Experience in risk management, decision-making, strategic execution is critical to project and program success and ensuring pipeline decisions can be made on sound data.

• Possesses good communication skills and strong stakeholder management skills. Able to easily build relationships and gains cross functional alignment

• Demonstration of successful coaching, mentoring, and people management (remote management experience preferred).

• Experience in successful study initiation through study completion, primary data analysis, and/or in multiple phases of studies (Phase 1-4).

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.

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