Director Clinical Operations

Responsibilities:
- Develop program-level operational strategy; ensure cross-functional alignment, lessons learned consistency, and KPI monitoring.
- Deliver operational strategy aligned with the Clinical Development Plan (resourcing, budget, change control, CDST partnership, and timeline creation).
- Represent assigned programs in cross-functional/executive governance; present operational strategy, risks, trade-offs, and drive data-informed decisions; attend CDST and provide study updates.
- Lead operational scenario planning; mitigate program-level risks affecting timelines/budget; ensure quality oversight; escalate issues to CDST, Quality, and functional leadership.
- Communicate, defend, and present operational plan and associated costs.
- Lead inspection readiness; provide leadership during Health Authority inspections and manage program-level risk/mitigation plans.
- Provide operational leadership/support to Associate Directors; build and develop a capable team for clinical trial setup and delivery.
- Oversee resource allocation; promote cross-functional collaboration.
- Set objectives aligned to company/program/department goals; ensure staff training on role procedures/systems; manage performance and individual growth.
- Present/discuss study data with development partners; collaborate with clinical development and scientific teams for data writing/presentation/publication.
- Direct CRO/vendor outsourcing strategy and KPIs to ensure high-quality regulatory-supporting data.
- Engage peers to share lessons learned/best practices across therapeutic areas.

Qualifications:
- BSc/BA required; advanced degree preferred.
- 10+ years’ experience with a CRO and/or biopharmaceutical company.
- 5+ years line management experience, or 5 years matrixed leadership experience.
- Ability to travel 10–15%.

Key Skills:
- Lead/manage externally outsourced cross-functional teams.
- Pharmaceutical development process knowledge.
- Clinical research operational expertise across phases 1–4; ability to manage all trial execution aspects.
- Excellent decision-making/analytical and strong financial management.
- Strong project planning/management; communication and presentation.
- Leadership skills; foster team productivity/cohesiveness.
- Experience leading without authority in global matrix environments; operate with limited supervision.
- Flexible, willing to work outside immediate responsibilities (“multiple hats”).
- Strategic problem-solving across drug discovery/development; credibility to represent company externally.