Associate Director, Clinical Operations (Retina)

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 for blinding retinal vascular diseases, offering multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection. The Company’s lead indication for 4D-150 is wet age-related macular degeneration (Phase 3) and diabetic macular edema. The second product candidate, 4D-710, 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.

About the role

The Associate Director, Clinical Operations will be responsible for implementation, execution, and oversight of all clinical trials within a clinical program, in coordination with cross-functional project teams to ensure that assigned clinical trials are executed on time, within budget, and in compliance with GCP and other applicable guidelines and regulations.

Responsibilities

• Partner with Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines.
• Provide operational leadership for the direction, planning, execution, and interpretation of clinical trials and data collection by developing and monitoring clinical trial/program timelines, budgets, risks, and mitigation plans.
• Mentor Clinical Trial Managers (CTMs) and junior team members in study document development, vendor and study management, study implementation, issue resolution, timelines, budgeting, and resourcing.
• Independently oversee day-to-day activities of the Clinical Trial Operations and Clinical Data Management groups.
• Collaborate with Finance/Business Operations on annual budget planning (external spend), quarterly budget reviews, and re-forecasts; design, implement, and oversee clinical vendor outsourcing strategy; participate in vendor selection and governance.
• Ensure each clinical trial is always inspection-ready and actively managed by a cross-functional Study Execution Team (SET).
• Serve as Clinical Operations subject matter expert (SME) on product cross-functional core teams.
• Partner with Quality to ensure programs and 4DMT remain inspection-ready.
• Collaborate with Regulatory Affairs and Clinical Sciences on regulatory submissions and compliance (e.g., ClinicalTrials.gov).
• Address escalated study issues in collaboration with CTMs and senior management, including risk mitigation plans.
• Coordinate the development and maintenance of clinical SOPs and provide review/input for cross-functional SOPs and documents.
• Support development and review of protocols/amendments, study documents, and operational execution.
• Actively participate in CRO, site, and vendor selection to ensure alignment with corporate objectives; monitor progress and trigger contingency plans as needed.
• Contribute to Clinical Operations department processes and manage clinical resources for effective trial implementation.

Requirements

• B.S./B.A. in Life Science or related discipline required; advanced degree (M.S./M.A., MPH, MHS, MBA) preferred.
• Clinical Research certification preferred but not required.
• B.S./B.A. with 9+ years of industry experience in clinical development (minimum 3 years managerial experience) or M.A./M.S. with 4+ years of experience.
• Ophthalmology/Retina experience required.
• Relevant experience in clinical trial execution across all phases.

Skills

• Proven ability to recruit, retain, organize, and motivate clinical operations personnel.
• Ability to communicate updates and priorities to leadership and advocate for budget/resources.
• Experience managing programs with corporate-wide impact.
• Ability to develop and manage functional and clinical trial-specific budgets.
• Self-motivated with strong prioritization and attention to detail.
• Strong interpersonal skills for cross-functional collaboration.
• Thorough knowledge of FDA/ICH Guidelines, GCP, medical terminology, and clinical trials.
• Flexibility and adaptability to changing business needs.
• Excellent written and verbal communication skills.
• Ability to present complex information to diverse audiences.

Pay

Base salary compensation range: $179,000 – $196,000. Actual salary depends on factors such as geographical location, relevant work experience, skills, and years of experience.

Schedule

• Travel: Anticipate 20%, or as trial needs demand.

Physical Requirements and Working Conditions

• Physical Activity:
  • Repetitive motions: Substantial movements of the wrists, hands, and/or fingers.
  • Fingering: Picking, pinching, typing, or otherwise working primarily with fingers.
  • Talking: Expressing or exchanging ideas by spoken word.
• Physical Requirements: Sedentary work: Exerting up to 10 pounds of force occasionally; sitting most of the time.
• Working Conditions: Typical office or administrative work; not substantially exposed to adverse environmental conditions.