Note: The job is a remote job and is open to candidates in USA. 4D Molecular Therapeutics is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The Director, Clinical Operations will provide strategic and operational leadership for global clinical trial execution across the lung portfolio, ensuring efficient and high-quality execution of Phase 1–3 clinical studies.
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
Skills
- B.S./B.A. in Life Science or related 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 direct line management experience
- Relevant experience in clinical trial execution across all phases
- 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
- 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
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