Program Lead II

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Act as a strategic champion for pipeline assets, bridging clinical science with operational execution of clinical research initiatives.

• Formulate clinical operational strategies that align with asset objectives and oversee the execution of clinical studies/programs.

• Create operational timelines and enrollment strategies, evaluate patient population availability, and weigh trial complexity against speed.

• Assess programmatic risks and mitigation strategies while identifying strategic alternatives for asset teams.

• Influence management and cross-functional teams to meet program goals.

• Contribute to portfolio planning, including clinical development costs, resource forecasts, and timelines.

• Review and provide clinical operations content for essential clinical and regulatory documentation, including INDs, IBs, NDAs, BLAs, MAAs, and regulatory briefing books.

• Oversee external budgets across portfolios, which range from $20 million to $200 million.

• Lead extensive cross-functional innovation and process improvement initiatives while managing change.

• Develop, manage, mentor, and supervise clinical operations personnel, including 4–15 study managers and up to 30 indirect reports.

• Implement clinical programs in accordance with ICH/GCP, global regulations, and AbbVie policies and procedures.

⛳️ Requirements

• Bachelor’s degree or equivalent, typically in nursing or a scientific discipline; an Associate’s degree/R.N. or equivalent with relevant experience is acceptable.

• 12+ years of experience in pharma-related or clinical research roles and/or relevant work experience.

• 10 years of clinical research experience and/or relevant work experience demonstrating core, technical, and leadership skills.

• Proven experience in setting and driving study strategies and leading a global team to manage and complete multiple clinical studies.

• Expertise in risk management, decision-making, and strategic execution.

• Strong communication abilities.

• Successful track record in coaching, mentoring, and managing personnel; experience in remote management is preferred.

• Subject-matter expertise in standard business procedures, including ICH, global regulations, ethics, and compliance.

• Involvement in clinical operations initiatives or advancement of clinical operations strategies.

• Experience from study initiation to completion, including primary data analysis and/or multiple study phases (Phase 1–3, 4).

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) plan.

• Eligibility to participate in long-term incentive programs.

• Equal opportunity employer.

• Reasonable accommodations for applicants with disabilities.