New · posted Nov 10
4D Molecular Therapeutics · Biotechnology
Associate Director, Clinical Operations (Contract)
- Remote, US
- Remote
- Contract
- Director
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.
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 biologics (aflibercept and anti-VEGF-C) with a single 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 and the second indication is diabetic macular edema, which are both in Phase 3 development. 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.
We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our Core Values drive the way we work together:
- Dare to Cure
- Break Boundaries
- Beyond Yourself
- Prepare & Execute Relentlessly
Join us in creating the future of genetic medicine.
What you need
Education
- 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.
Experience
- B.S./B.A. with 9+ years of industry experience in clinical development with a minimum of 3 years managerial experience, or M.A./M.S. with 4+ years of experience.
- Require 1+ years ophthalmology trial experience as well as late phase trial experience. Relevant experience in clinical trial execution across all phases
Other Qualifications/Skills:
- Proven ability to recruit, retain, organize, and motivate clinical operations personnel
- Ability to communicate to Clinical Operations and Development Leadership team updates and priorities as well as to advocate for required budget and resources
- Ability to manage and oversee 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; show attention to detail
- Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance
- 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
Travel: Anticipate 20%, or as trial needs demand
Physical Requirements and Working Conditions:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
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.
What you'll do
- Partner with Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines
- Provide operational leadership to the direction, planning, execution and interpretation of clinical trials and data collection by effectively developing and monitoring clinical trial/program timelines, budgets, risks and mitigation plans
- Provides guidance and mentoring to Clinical Trial Managers (CTMs) and junior level 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) as well as quarterly budget reviews and re-forecasts; designing, implementing, and overseeing clinical vendor outsourcing strategy; actively participating in the selection of vendors to support 4DMT clinical trials as well as active governance of them; participating and/or leading vendor governance committees
- Ensure that each clinical trial is always inspection ready
- Ensure that each clinical trial is being actively managed by a cross-functional Study Execution Team (SET)
- May sit on product cross-functional core teams as Clinical Operations SME
- Partner closely with Quality to ensure that the programs and 4DMT always remain inspection ready
- Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (eg, Clincialtrials.gov)
- Addresses escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans
- Coordinates the development and maintenance of clinical SOPs as pertains to the program and provides review/ input into cross-functional SOPs and other documents
- Supports development and review of protocols/ amendments, study documents and plans, and operational execution
- Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate
- Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials.
Pay
$191,360 – $222,560 a year
Employer provided$92.00 – $107.00 an hour · yearly at 2,080 hours (40 a week)
How this comparesBase salary compensation range: $92.00-$107.00/ HOUR
Equal opportunity, accessibility and legal notices4D Molecular Therapeutics's statements, word for word
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. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% below the US median for Clinical Operations roles at this level.
This roleEmployer provided
Director roles in the US41 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $191,360 | — | $222,560 |
| All US (middle half) | $202,000 | $233,000 | $244,000 |
This role: 4D Molecular Therapeutics's own published range, converted to a year at 2,080 hours. Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 102 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not 4D Molecular Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 46 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct16
- Collaboration and leadership14
- GMP and compliance6
- Documentation and SOPs4
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Operations work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
Company hiring pulse
4D Molecular Therapeutics on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 2
- Locations
By discipline
- Clinical4 67%
- Regulatory2 33%
By level
- VP & Executive2 33%
- Director2 33%
- Manager1 17%
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Associate Director, Clinical Operations (Contract) at 4D Molecular Therapeutics
Open until filled. $191K–$223K a year, employer provided.