4D Molecular Therapeutics

Clinical Operations

• Provide strategic and operational leadership for global clinical trial execution across the 4DMT lung portfolio.
• Responsible for delivering clinical programs aligned with corporate timelines, budget, quality, and regulatory expectations.
• Lead internal Clinical Operations teams and external partners/CROs.
• Collaborate with external teams to ensure efficient, high-quality, inspection-ready execution of Phase 1–3 clinical studies.
• Serve as a key cross-functional leader and Clinical Operations subject matter expert.

Director, Clinical Operations – Lung Program

Translator

• Set, communicate and drive strategy for Translational products in alignment with the broader organization of 4DMT
• Prioritize and allocate resources, both within Translational and beyond, to meet portfolio needs
• Lead the decision-making process with other relevant functional group heads regarding indications, targets and products’ progression from concept, design, preclinical development and Phase 1-2 clinical testing.
• Provide input on scientific strategy from the earliest consideration of new targets through development, including risk, scientific challenges, timing of resource investment and development of go/no go decisions
• Direct and coordinate the implementation of preclinical study programs for pharmacology studies in support of the lead to candidate optimization process
• Design, implement and write-up comprehensive series of pharmacology studies to address preclinical exposure, develop pharmacokinetics and pharmacodynamics profiles and generate GLP toxicology and bio-distribution packages suitable for supporting IND filings
• Manage budgets and headcounts
• Design, implement and manage externally facing in vivo studies with CROs and academic centers, including drafting proposals, budget oversight and managing deliverables
• Resource planning; hiring and mentoring talents; building the team and technical capabilities
• Build collaborations with relevant functions at 4DMT; represent own function at the corporate level and externally
• Provide direct hands-on responsibility for all Translational interactions as well as grant writing and management with rare disease advocacy groups
• Participate on project teams and direct activities to ensure regulatory compliance of pre-clinical and clinical research activities
• Support regulatory affairs in their preparation, review and submission of necessary pre-clinical and clinical regulatory information to regulatory agencies worldwide
• Contribute to defining of clear human POC study outcome criteria for decision-making on new product candidates
• Contribute senior level expertise to alliance, business development, due diligence exercises with external entities and licensing meetings as well as other critical external interfaces such as public health regulatory bodies
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

Executive Director – Preclinical and Translational Sciences

Research Analyst

• Support study execution across start-up, conduct, and close-out phases
• Serve as a primary point of contact for assigned clinical sites and CRO field CRAs/monitors
• Communicate directly with sites and CRO partners to obtain updates, resolve issues, and support study timelines
• Support site initiation, ongoing site management, and site close-out activities
• Assist with identification, documentation, tracking, and follow-up of site issues
• Support oversight of CRO monitoring activities
• Review monitoring visit reports and follow up on action items and unresolved findings
• Track monitoring deliverables and escalate issues to the Associate Director, Clinical Operations as appropriate
• Support inspection readiness and audit activities
• Maintain accurate tracking tools for assigned studies, including:
• Site start up and activation status
• Subject enrollment and visit status
• Essential document collection and TMF status
• Vendor reconciliation
• Assist with preparation of study status reports and metrics
• Collect, review, and track site regulatory documents for completeness, accuracy, and compliance with applicable SOPs and regulatory requirements
• Ensure timely filing of documents in the TMF/eTMF in accordance with TMF plans
• Perform TMF quality control activities and support TMF audits and study close out
• Support organization and coordination of internal team meetings, investigator meetings, and other study related meetings
• Prepare meeting materials, take meeting minutes, and maintain action item logs
• Support communication of study updates to internal stakeholders

Clinical Research Associate – Contract

QA Engineer

• Provide Quality oversight for multiple 4DMT Clinical Studies, including the following study-specific activities:
• Develop and implement Clinical Study Quality Plans for specific 4DMT clinical studies, focused on ensuring subject safety/rights, study data integrity, and GCP compliance.
• Provide guidance and support to clinical study teams, including via attendance at Study team meetings and via investigation and management of Clinical Study Quality Events.
• Ensure principles of Risk Management are applied to the Clinical Study per ICH E6.
• Identify, communicate, and escalate significant incidents of GCP non-compliance and follow to resolution, acting at all times with an appropriate sense of urgency.
• Plan, perform, and/or oversee GCP Compliance audits of high-risk clinical vendors/sites, including clinical investigator sites.
• Ensure audit findings are communicated to audit stakeholders and collaborate with auditees and vendors to track, review, approve, and assess the adequacy of CAPAs.
• Perform Clinical Document reviews, ensuring the quality, accuracy and completeness of various documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 Tabulated and Written Summaries, and Integrated Summaries.

Director, Clinical Quality Assurance – CQA

Recruitment

• Manage full-cycle recruitment for assigned roles, including sourcing, screening, interviewing, and offer negotiation
• Partner with hiring managers to understand hiring needs, define role requirements, and develop candidate profiles
• Proactively source and engage candidates using a variety of channels, including LinkedIn Recruiter and networking
• Draft and refine job descriptions in partnership with HR and Total Rewards, ensuring alignment with leveling and compensation frameworks
• Coordinate and drive interview processes, including scheduling, debrief facilitation, and delivery of structured feedback
• Support offer development and negotiation in alignment with company compensation philosophy
• Partner with external search firms and staffing agencies as needed; help ensure quality and cost-effectiveness of vendor support
• Track and maintain recruiting data, ensuring accuracy in systems such as Greenhouse and contributing to hiring metrics and reporting
• Support execution of hiring plans in alignment with approved headcount and business priorities
• Identify opportunities to improve recruiting processes, tools, and candidate experience
• Stay informed on industry trends and talent market dynamics within biotech/pharma
• Promote inclusive hiring practices and support efforts to mitigate bias in the recruiting process
• Participate in special projects and broader Talent Acquisition or HR initiatives as needed

Senior Recruiter – Contract

Clinical Research

• Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial
• Lead cross-functional study execution team in support of study deliverables
• Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
• Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents
• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
• Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files
• Negotiate and finalize site contracts and budgets
• Manage clinical trial budgets, providing ongoing financial reporting and projections
• Perform and manage data review process on an ongoing basis
• Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed
• Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues.

Director, Clinical Operations – Lung Program

Executive Director – Preclinical and Translational Sciences

Clinical Research Associate – Contract

Director, Clinical Quality Assurance – CQA

Senior Recruiter – Contract

Clinical Trial Manager – Contract