Program Lead II, Clinical Program Development (Director Level)
About The Position
The Clinical Operations Program Director connects science and operations to bring clinical studies to life through the execution of one or more clinical research programs. The role serves as a strategic advocate for pipeline assets, translating scientific experiments into operational plans through scientific expertise, strategic thinking, a global mindset, and innovative solutions to address risks and challenges. It also provides people leadership and develops talent for the Development Operations organization. The position works across the Pipeline Commercialization Model’s Integrated Evidence Strategy Team, Asset Strategy Team, Development Review Committee, and cross-functional partners to maximize the value of assets and the portfolio for patients and AbbVie. It develops operational strategies aligned with asset strategy and oversees clinical program execution, planning, risk management, budgets, resources, timelines, regulatory content, and process improvement. The role also manages and mentors clinical operations staff, including direct supervision of study managers and oversight of indirect staff, while ensuring program compliance with applicable quality standards.
Requirements
- Bachelor’s degree or equivalent, typically in nursing or a scientific field; an Associate’s degree/R.N. or equivalent with relevant experience is acceptable.
- 12 or more years of pharma-related or clinical research-related experience, and/or applicable work experience.
- 10 years of clinical research experience, and/or applicable work experience, demonstrating core, technical, and leadership competencies through setting and driving study strategy and leading a global team in the management and completion of multiple clinical studies.
- Experience in risk management, decision-making, and strategic execution.
- Good communication skills.
- Demonstrated success in coaching, mentoring, and people management.
- Subject matter expertise in applying standard business procedures, including ICH, global regulations, ethics, and compliance.
- Experience successfully advancing studies from initiation through completion, including primary data analysis and/or work across multiple study phases (Phase I–III or IV).
Nice To Haves
- Remote management experience.
- Integral participation in clinical operations initiatives or advancement of clinical operations strategies.
Responsibilities
- Serve as an integral member of the Pipeline Commercialization Model’s Integrated Evidence Strategy Team and as a strategic partner to the Asset Strategy Team and Development Review Committee.
- Develop clinical operational strategies aligned with asset strategy and scientific and operational considerations, and oversee execution of clinical studies and programs.
- Develop operational timelines and enrollment options, assess patient population availability, and balance trial-design complexity against speed.
- Evaluate program risks and mitigations, and identify strategic options for the Asset Strategy Team in response to competing priorities, interests, or unexpected challenges.
- Influence management and cross-functional team members to achieve program objectives, including colleagues in Development Operations, clinical trial execution, and Development and Global Medical Affairs Therapeutic Areas.
- Contribute to portfolio planning, including developing cost and resource projections and timelines for clinical development programs.
- Review and provide clinical operations content for clinical and regulatory documents, including INDs, IBs, NDAs, BLAs, MAAs, and regulatory briefing books.
- Manage external budgets across the portfolio; programs may have budgets of $20 million to $200 million.
- Lead large-scale, cross-functional innovation and process-improvement initiatives with significant business impact, and ensure effective change management.
- Develop, manage, and mentor direct and indirect clinical operations staff, including strategic leadership and direct supervision of 4–15 study managers and up to 30 indirect staff.
- Support staff career development and foster an inclusive, innovative, and learning environment.
- Execute clinical programs in compliance with ICH/GCP, global regulations, and AbbVie policies and procedures.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance.
- 401(k).
- Eligibility to participate in long-term incentive programs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
