Director, Clinical Operations

Responsibilities:
- Accountable for operational strategic planning, oversight, and delivery of all Clinical Operations activities within the development team and in accordance with the CDP.
- Provide direction, mentorship, and guidance to Clinical Operations staff assigned to the clinical program.
- Contribute at a strategic level, including input into risk management plans, business value assessment, and therapeutic area indication operational expertise; guide trials to be properly defined, planned, and executed across clinical-stage programs.
- Contribute to clinical asset life cycle and clinical development plans; establish operational plans for new programs/studies (scenario planning, timeline forecasting, feasibility assessment, resource/budget estimation using benchmarks, and operational strategy development); align with therapeutic area, Product Strategy Team, and functional leadership; communicate budgets/timelines/changes to governance.
- Provide proactive, innovative, and flexible operational solutions for the CDP.
- Ensure operational deliverables are met on time, within budget, and to quality; maintain program status/issue oversight and proactively communicate progress and impacts to stakeholders.
- Maintain internal consistency across studies within a program and alignment with functional standards.
- Contribute to asset and program management across the Product Strategy Team as the CPD.
- Collaborate with internal/external partners to align operational program goals.
- Provide program guidance to matrix Clinical Operations teams (trial management expertise, operational strategies, direction).
- Mentor and guide Clinical Operations staff (including junior CPDs); provide timely feedback on staffing needs and performance; may include line management/career development.
- May be assigned to one or more complex programs; may represent Operations in stakeholder initiatives and process/resource optimization.

Qualifications:
- BS in Scientific, Medical, or Healthcare subject (required).
- 12+ years Clinical Operations experience (10+ years for M.S.), including biopharmaceutical clinical trial management.
- Oncology experience (preferred).
- Extensive pharmaceutical industry/drug development experience; knowledge of applicable global regulations and industry guidelines.
- Demonstrated global clinical program management across phases I–III.
- Substantial experience organizing, implementing, and delivering global clinical programs.
- Thorough understanding of all aspects of clinical drug development; strategic planning; ability to assess global clinical development plans, protocol design, resources, global budgets, and timelines.
- Experience developing teams in matrix/growing environments.
- Analytical skills (forecasting and analyzing multiple data sources).
- Leadership, influencing, communication, and strategic project management skills.
- Effective verbal/written English communication; additional languages may be an asset.
- Ability to work self-guided with appropriate consultation.
- Travel: ~10–25% national/international (as needed).