4D Molecular Therapeutics

4D Molecular Therapeutics

Director, Clinical Operations (Lung Program)

Remote, United States · Director

Sponsorship not specified$225k-$246kDetected 8 days ago
GCPBusiness DevelopmentNegotiationForecastingBudgetingProcess ImprovementRecruitingPerformance ManagementClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationAdaptabilityOrganizational SkillsRegulatory Affairs

About the role

  • Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team.
  • No unsolicited resumes will be accepted.
  • The 4DMT Talent Acquisition team must expressly engage agencies on any requisition.

Responsibilities

  • 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.
  • 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.
  • Develop and execute global clinical operations strategies aligned with corporate objectives, program timelines, budgets, quality standards, and regulatory requirements.
  • 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.
  • Develop and present program updates, operational metrics, key risks, and mitigation strategies to senior leadership and executive management.

Requirements

  • 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.
  • Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
  • Education:
  • 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

Nice to have

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

Skills

  • Proven ability to recruit, retain, organize, and motivate clinical operations personnel
  • 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
  • Other Qualifications/Skills:

Compensation

  • 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.
  • $225,000 - 246,000
  • Lead Clinical Operations contributions to annual budget planning, quarterly forecasting, resource planning, and financial oversight for assigned programs.

Benefits

  • Ensure continuous inspection readiness across clinical programs, including oversight of TMF quality, audit preparedness, CAPA management, and health authority inspection support.

Equal opportunity

  • Employer/Protected Veterans/Individuals with Disabilities
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Visa & Work Authorization

  • Lead sponsor-side oversight and governance of CROs and critical vendors, including vendor selection, performance management, issue escalation, quality oversight, budget accountability, and ope
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