The Role

The Director, Clinical Operations will provide project management of all clinical development activities for Third Harmonic Bio in support of THRD’s clinical development programs and will deliver data-driven, actionable operational and strategic insights for execution of a clinical development program and all associated studies for Third Harmonic Bio. This role will lead Operational Insights Generation, Clinical Sub Team Goal Management and Cross-functional Engagements; successfully influencing leadership and cross-functional partners to develop strategies and execute plans to achieve program objectives.

Responsibilities

• Leads cross-functional teams, creation and management of appropriate clinical program development strategies for attainment of clinical program objectives. Provides traditional program management deliverables such as, but not limited to, MS/other Project schedules, team agendas and meeting minutes, program budget summaries, key drivers, decisions taken and other program history.
• Identifies and oversees CROs and other vendors to support the clinical development program; lead optimization of assigned Clinical Operations process, organization and decision making, including driving, and tracking KPIs.
• Manage/oversee all clinical trial related activities from feasibility and site selection through monitoring and study close out; ensure appropriate scoping of projects & contribute expertise/insights to develop, implement and lead key strategic initiative/plans.
• Provide operational input for clinical project plans, protocols, and timelines; plan, track, and manage project tasks, milestones, dependencies, and identify elements on critical path.
• Lead support for insight driven Clinical Operations strategic & operational decision-making by leveraging internally & externally available data sources.
• Leads the Clinical Operations Team in developing and continuously reviewing the overall clinical product development strategy. Ensures that alternative and backup scenarios are prepared and available to implement, as part of the living program plan. Will need to organize and execute periodic and frequent “re-planning” sessions.
• Supports the tracking of actuals to budget and communication of deviations to budget or prospectively identified variations. Ensures guidance is given to enable team and functional leads to estimate and monitor resource requirements (timelines, money,i people and other resource needs) for the program to meet its deliverables.
• Ensures timely action against development issues. Strong project management skills – organized, disciplined, comfortable following up on actionable / holding people accountable, able to think ahead and catch problems before they arise.
• Execute clinical programs in compliance with quality standards (THRD SOPs, GxPs, and CFR and ICH guidelines and all applicable procedures)
• Maintain a state of inspection readiness, and act as an expert during regulatory inspections.
• Perform operational decision making, risk mitigation, and contingency planning as well as operational efficiency and innovation at the program level.
• Review and provide clinical operations content to clinical and regulatory documents (IND, IB, NDA, MAA, Regulatory Briefing Books etc.)

Minimum Qualifications

• BA/BS in a related field required; advanced degree highly preferred.
• Strong project management skills with proficiency in use of project management software and web-based collaboration tools.
• At least 7-10 years of industry experience managing clinical programs at a pharmaceutical or biotechnology company. Experience managing a clinical development program and team through a successful NDA is preferred.
• Experience with global project teams is preferred.
• Highly adaptable, ability to work in an extremely fast-paced environment.
• Excellent communication skills
• Technical background sufficient to facilitate complex discussions and decisions surrounding pharmaceutical and/or medical device commercialization
• Must have demonstrated success in a high science organization
• Must have experience developing teams and be recognized as a strong leader
• Proven experience working at the senior management level required.
• Position is primarily remote with offices in Cambridge, MA and San Francisco, CA. Cambridge, MA is the primary office location for this position. Minimum in office attendance estimated at 1-3 days per week.
• Occasional travel required for this role
• Strong communications, comfortable negotiating and making decisions. Must be comfortable presenting, sharing opinions and recommendations as well as managing up and down.

The estimated base salary range for this role is: $194,000-$220,000.