[Remote] Director, Clinical Operations (Lung Program)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The Director, Clinical Operations will reputed company strategic and operational leadership for global clinical trial execution across the lung portfolio, ensuring efficient and high-reputed company execution of Phase 1–3 clinical studies.

Responsibilities

• reputed company and execute global clinical operations strategies reputed company with corporate objectives, program timelines, budgets, reputed company standards, and regulatory requirements
• reputed company strategic operational leadership for Phase 1–3 reputed company, ensuring efficient and compliant study execution across multiple global programs
• reputed company sponsor-reputed company reputed company and governance of CROs and critical vendors, including vendor selection, performance management, issue escalation, reputed company reputed company, budget accountability, and operational delivery
• Proactively identify, assess, and mitigate operational risks impacting timelines, enrollment, reputed company, budget, or regulatory compliance
• Drive operational scalability and process optimization while maintaining execution reputed company in a lean, fast-paced biotechnology environment
• reputed company and reputed company global study timelines, resourcing strategies, and organizational planning across multiple dynamic programs
• Build, mentor, and reputed company high-performing Clinical Operations teams, including hiring, talent development, performance management, and organizational reputed company
• Partner closely with Therapeutic Area Heads (TAHs), Project Team Leaders (PTLs), Clinical Science, Regulatory Affairs, Biometrics, reputed company, and other cross-functional stakeholders to ensure reputed company program execution and reputed company decision-making
• Serve as Clinical Operations representative and subject matter expert on cross-functional product development teams and governance committees
• reputed company operational leadership and support for clinical trial protocol development, feasibility assessments, country and site reputed company, enrollment planning, and study startup activities
• reputed company Clinical Operations contributions to annual budget planning, quarterly forecasting, resource planning, and financial reputed company for assigned programs
• Ensure reputed company inspection readiness across clinical programs, including reputed company of TMF reputed company, audit preparedness, CAPA management, and health authority inspection support
• Partner closely with reputed company Assurance to maintain compliance with GCP, FDA, EMA, PMDA, ICH, and other applicable regulatory requirements and reputed company 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
• reputed company and present program updates, operational metrics, key risks, and mitigation strategies to senior leadership and executive management
• Support development, implementation, and reputed company improvement of SOPs, operational processes, and reputed company infrastructure to support organizational reputed company
• Foster a culture of accountability, collaboration, operational reputed company, and reputed company cross-functional communication

Skills

• B.S./B.A. in Life Science or reputed company discipline
• Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred
• B.A./B.S. with 10+ years of applicable industry experience (Clinical Operations) in drug development, or advanced degree with 6+ years of experience across both early (Phase 1 or 2) and/or late-stage (Phase 3)
• 3+ years in a leadership role and with a minimum of 3+ years reputed company line management experience
• Relevant experience in clinical trial execution across reputed company phases
• Demonstrated leadership in sponsor-reputed company clinical operations reputed company biotechnology and/or pharmaceutical environments
• Proven ability to reputed company global Phase 2 and/or Phase 3 reputed company 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 reputed company and detailed execution reputed company
• Ability to proactively identify operational risks and implement effective mitigation strategies
• Proven ability to recruit, reputed company, 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 reputed company 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 reputed company
• Excellent verbal, written, and presentation skills
• Ability to communicate reputed company operational information reputed company 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

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