GENERAL SUMMARY:

Provide strategic and operational leadership for global clinical trial execution across the 4DMT lung portfolio. This role is responsible for delivering clinical programs aligned with corporate timelines, budget, quality, and regulatory expectations while building scalable operational infrastructure appropriate for a fast-paced biotechnology environment. The Director, Clinical Operations will lead internal Clinical Operations teams and external partners/CROs and collaborate with external teams to ensure efficient, high-quality, inspection-ready execution of Phase 1–3 clinical studies.

This individual will serve as a key cross-functional leader and Clinical Operations subject matter expert, driving operational strategy, proactive risk mitigation, and execution excellence across global development programs.

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.
• Serve as Clinical Operations representative and subject matter expert on cross-functional product development teams and governance committees.
• 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.
• Ability to proactively identify operational risks and implement effective mitigation strategies.
• 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.

QUALIFICATIONS:

Education:

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

Experience:

• 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 direct line management experience.
• Relevant experience in clinical trial execution across all phases.

Other Qualifications/Skills:

• • Proven ability to recruit, retain, organize, and motivate clinical operations personnel
  • Ability to communicate to leadership team on Clinical Operations updates and priorities as well as to advocate for required budget and resources
  • Ability to manage and oversee large scale programs that have corporate-wide impact
  • Ability to develop and manage functional and clinical trial-specific budgets
  • Must be self-motivating; prioritize and manage a large volume of work; show attention to detail
  • Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance
  • Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
  • Ability to be flexible and adaptable to changing business needs
  • Excellent communication and interpersonal skills
  • Must be able to write clearly and summarize information effectively
  • Must be able to present complex information to various audiences

Base salary compensation range: $225,000 - 250,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.