Director, Clinical Operations (Lung Program)

Major Duties & Responsibilities

• Develop and execute global clinical operations strategies aligned with corporate objectives, program timelines, budgets, quality standards, and regulatory requirements.
• Provide strategic operational leadership for Phase 1–3 clinical trials, ensuring efficient and compliant study execution across multiple global programs.
• Lead sponsor-side oversight and governance of CROs and critical vendors, including vendor selection, performance management, issue escalation, quality oversight, budget accountability, and operational delivery.
• Proactively identify, assess, and mitigate operational risks impacting timelines, enrollment, quality, budget, or regulatory compliance.
• Drive operational scalability and process optimization while maintaining execution excellence in a lean, fast-paced biotechnology environment.
• Develop and oversee global study timelines, resourcing strategies, and organizational planning across multiple dynamic programs.
• Build, mentor, and lead high-performing Clinical Operations teams, including hiring, talent development, performance management, and organizational growth.
• Partner closely with Therapeutic Area Heads (TAHs), Project Team Leaders (PTLs), Clinical Science, Regulatory Affairs, Biometrics, Quality, and other cross-functional stakeholders to ensure aligned program execution and timely decision-making.
• Provide operational leadership and support for clinical trial protocol development, feasibility assessments, country and site strategy, enrollment planning, and study startup activities.
• Lead Clinical Operations contributions to annual budget planning, quarterly forecasting, resource planning, and financial oversight for assigned programs.
• Ensure continuous inspection readiness across clinical programs, including oversight of TMF quality, audit preparedness, CAPA management, and health authority inspection support.
• Partner closely with Quality Assurance to maintain compliance with GCP, FDA, EMA, PMDA, ICH, and other applicable regulatory requirements and quality standards.
• Collaborate with Regulatory Affairs and Clinical Science to support regulatory submissions and ongoing compliance requirements, including ClinicalTrials.gov disclosures and global regulatory obligations.
• Contribute operational expertise to business development and due diligence activities, as applicable.
• Develop and present program updates, operational metrics, key risks, and mitigation strategies to senior leadership and executive management.
• Support development, implementation, and continuous improvement of SOPs, operational processes, and scalable infrastructure to support organizational growth.
• Foster a culture of accountability, collaboration, operational excellence, and clear cross-functional communication.

Core Competencies, Knowledge & Skill Requirements

• Demonstrated leadership in sponsor-side clinical operations within biotechnology and/or pharmaceutical environments.
• Proven ability to lead global Phase 2 and/or Phase 3 clinical trials with accountability for operational delivery.
• Strong experience managing CROs and external vendors from the sponsor perspective.
• Demonstrated ability to influence cross-functional stakeholders and drive decision-making in ambiguous or rapidly evolving environments.
• Strong operational and strategic leadership skills with ability to balance high-level portfolio strategy and detailed execution oversight.
• Proven ability to recruit, develop, retain, and motivate high-performing Clinical Operations teams.
• Strong financial acumen with experience managing clinical trial budgets, forecasts, and resource planning.
• Deep understanding of FDA, EMA, PMDA, ICH-GCP guidelines, and global clinical trial regulations.
• Experience supporting inspection readiness activities, audits, and regulatory inspections.
• Excellent organizational skills with the ability to manage multiple complex global programs simultaneously.
• Strong communication, presentation, negotiation, and interpersonal skills.
• Ability to operate effectively in a lean, fast-paced, and evolving biotechnology environment.
• High degree of accountability, ownership, adaptability, and execution focus.

Communication & Interpersonal Skills

• Excellent verbal, written, and presentation skills.
• Ability to communicate complex operational information clearly and concisely to technical and non-technical audiences, including executive leadership.
• Strong collaboration and relationship-building skills across internal teams and external partners.
• Demonstrated ability to influence without authority and drive alignment across cross-functional stakeholders.

Education

• B.S./B.A. in Life Science or related discipline.
• Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred.