Director, Clinical Operations

Role Summary

Director, Clinical Operations is responsible for providing leadership to assigned clinical program(s) and ensuring studies within a program are managed in alignment with program goals, timelines, budgets, and quality expectations. This role ensures clinical trials comply with company procedures, regulatory requirements, GCP, and ICH, and may lead strategic improvements in clinical project execution and project management.

Responsibilities

• Provide leadership in the development of the clinical trial management, budget and resourcing strategy at a clinical program level as a Clinical Operations Program Lead.
• Collaborate with the SVP, Clinical Operations to align resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.
• Provide leadership to Clinical Projects to ensure trial/study teams are managed in alignment with clinical program and company goals.
• Provide Clinical Program updates, including trial status/metrics, budget, accomplishments and risks to relevant stakeholders.
• Oversee the strategic and operational delivery of clinical studies for one or more development products.
• Identify challenges or risks with clinical study conduct and implement mitigation plans.
• Represent Clinical Operations at Product Team discussions and provide strategic operational input.
• Resolve and/or escalate issues raised by the clinical operations team or SMT.
• Lead vendor selection, contract reviews and negotiation of work orders.
• Oversee CROs and other vendors at the product level, monitor KPIs, and ensure successful execution of programs/studies.
• Serve as main escalation point for strategic CRO partners and key stakeholders in clinical operations.
• Ensure consistency between studies for one or more products.
• Provide input on clinical trial design from an operations perspective.
• Author or oversee program level and study level documents to support clinical studies and regulatory submissions.
• Oversee financial aspects of assigned studies, including departmental operating plans and adherence to budgets.
• Direct strategic initiatives and oversee implementation for process and operational improvements.
• Oversee/co-lead inspection readiness activities and serve as SME during regulatory inspections.
• Work closely with Quality Assurance on SOP development.

Qualifications

• Advanced Degree in scientific or healthcare field preferred.
• 10+ years of clinical research and organizational management within the pharmaceutical industry; biotech/small pharma experience preferred.
• Global clinical trial research experience.
• Experience leading cross-functional teams.
• Experience in rare disease and/or liver disease is preferred.

Knowledge, Skills And Abilities

• Ability to present complex information to management, vendors and external audiences.
• Ability to create and manage program budgets and communicate overspend/underspend.
• Ability to manage vendor relationships, including negotiating contracts and analyzing scopes of work.
• Strong attention to detail and ability to set priorities for the team.
• Ability to work in a fast-paced environment across time zones and manage multiple tasks.
• Ability to work independently, take initiative and meet deadlines.
• Proven ability to lead, motivate and mentor staff and teams.
• Excellent written and oral communication skills.
• Professional demeanor with internal and external stakeholders.
• Ability to remove barriers to success.
• Detailed knowledge of current regulatory requirements governing clinical research (ICH/GCP).
• Previous line management experience.
• Strong knowledge of computer and project management software.
• In-depth knowledge of global regulatory/industry guidelines (ICH/GCP).