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4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery
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