Program Director

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $160,900 - $200,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

Program Director, EDEN Study (ARPA-H)

Build the operation behind a national effort to answer one of the biggest open questions in reproductive health

The question

Nearly every adult in the United States carries measurable levels of PFAS, bisphenols, phthalates, and hundreds of other environmental chemicals. Patients trying to conceive are told constantly that these exposures may be hurting their chances. Nobody knows whether that is true, which chemicals matter, or at what levels. The advice patients receive is well meaning, expensive, anxiety-provoking, and unproven.

EDEN (Environmental Determinants in Reproduction) is a multi-year, milestone-driven program funded by the Advanced Research Projects Agency for Health (ARPA-H) to answer that question definitively. Led by Dr. Zev Williams, Chief of Reproductive Endocrinology and Infertility and Director of the Columbia University Fertility Center, in partnership with Dr. Gary W. Miller, a pioneer of exposome science at Columbia's Mailman School of Public Health, the study will measure thousands of chemical exposures in blood, follicular fluid, and semen from patients undergoing fertility treatment and link them to the most detailed reproductive outcomes available in medicine: egg and sperm quality, fertilization, embryo development, chromosomal status, implantation, and pregnancy. It begins at Columbia, one of the highest-volume fertility centers in the country, and expands to clinics across the United States and to a cohort of military veterans. In its second phase it moves from correlation to cause, through laboratory models, animal studies, and a first-of-its-kind intervention study in patients.

Answer changes practice. If specific chemicals impair fertility, the result is individualized guidance for patients, and the evidence base for regulation. If they do not, millions of people get a science-based reason to stop worrying. Very few studies are designed so that both outcomes matter this much.

The role

We are hiring the person who will turn this scientific plan into a running, growing, auditable operation. The Program Director is the first key hire on EDEN and will own execution end to end: specimen and data pipelines across Columbia's three currently identified CUFC clinical sites (Manhattan, White Plains, and Teaneck), with additional sites added in the future; regulatory and compliance infrastructure; budget and subawards; onboarding of national partner sites and the VA; the interface with analytical partners; and reporting to ARPA-H. You will report directly to Dr. Williams, work closely with Dr. Miller's team, and function as the operating partner for scientific leadership rather than as an administrator.

This is a ground-floor position. The systems, standard operating procedures, staffing plan, and partner network do not yet exist; you will build them, and then you will scale them. ARPA-H programs run differently from NIH grants: aggressive negotiated milestones, go/no-go decision points, and an ARPA-H program manager who is actively engaged in the work. The pace is fast, the bar is high, and the autonomy is real. The person we are looking for finds that combination energizing.

Responsibilities

What you will do

Build the engine

• Translate the scientific protocol and the ARPA-H milestone schedule into concrete project plans, timelines, budgets, and staffing needs, and keep all of them current as the program evolves.
• Design and run the specimen pipeline: capture of remnant serum, follicular fluid, and semen at the point of clinical discard across Columbia's Manhattan, White Plains, and Teaneck sites; coding through an honest-broker system; labeling, chain of custody, cold-chain logistics, and tracking to a standard that will withstand audit; and shipment to analytical laboratories.
• Stand up the data infrastructure: extraction of clinical outcomes, de-identification, linkage to chemical results, and quality assurance, in coordination with biostatistics and data management.
• Own regulatory and compliance: IRB protocols and amendments, material transfer and data use agreements, Good Clinical Practice where applicable, and readiness for sponsor visits and audits.

Grow it

• Identify, recruit, and onboard partner fertility clinics across diverse regions of the country and the VA / NAVREF cohort, including site agreements, reliance arrangements, subawards, harmonized protocols, and training.
• Prepare the operational groundwork for Phase 2: the interventional pilot, laboratory and animal studies, and any additional cohorts, so that the program can move the moment the science says go.
• Recruit, hire, train, and lead the research staff (coordinators, laboratory technicians, data personnel), and build the SOPs and training that let the team run without the PI in every loop.

Run it with ARPA-H

• Serve as the day-to-day operational counterpart to the ARPA-H program office: milestone reports, go/no-go documentation, budget justifications, and rapid responses to program-level requests, in close coordination with Dr. Williams.
• Lead operational planning and execution of the randomized controlled trial at the Columbia University Fertility Center, including protocol implementation, participant coordination, regulatory oversight, staffing, data quality, and milestone delivery.
• Manage the budget across performance periods, track spending against milestones, and lead subaward and multi-site budget development as scope expands.
• Anticipate risk (specimen capture rates, site delays, supply chain, staffing, data quality) and build contingency plans before a risk becomes a milestone problem.
• Help identify and pursue opportunities to expand the program's scope and funding as it succeeds.
• Directly supervise the two specimen collection technicians at the Fertility Center, including training, scheduling, performance oversight, and quality assurance.
• Provide operational leadership for multi-site research coordinators (two per participating site), including standardized workflows, training, performance monitoring, and escalation.
• Support other ongoing research studies at the Columbia University Fertility Center and, as assigned by the Principal Investigator, lead their operational execution, including staff coordination, protocol implementation, regulatory compliance, and delivery of study milestones.
• Perform general administrative functions, and related duties and responsibilities as assigned/requested.

Who thrives here

You have run complex, longitudinal human-subjects research with biospecimens before, and you know the difference between administering a system and building one. You are comfortable being the most organized person in the room and the person everyone calls when they need to know exactly where things stand. You write clearly, you communicate with sponsors and senior scientists as peers, and you would rather own an outcome than a task list. You want to work on something whose answer will change what doctors tell patients, and you are excited rather than daunted by the idea that the operation you build will be several times larger in two years than it is today.

Minimum Qualifications

• Bachelor's degree and at least five years of progressively responsible experience managing complex human-subjects research, including clinical trials and direct experience with biospecimen collection, handling, and tracking.
• Five or more years of experience supervising research staff.
• Demonstrated success building operational systems, processes, and teams from the ground up in a research or clinical-trial setting.
• Direct experience with IRB submissions, regulatory compliance, and material transfer or data use agreements.
• Experience managing research budgets and tracking expenditure against deliverables or milestones.
• Exceptional organizational ability, independence, and judgment; a track record of managing many concurrent workstreams and driving them to completion.
• Strong written and verbal communication, including preparing progress or milestone reports for sponsors or senior leadership.

Preferred Qualifications

• Advanced degree (MPH, MS, MBA, PhD, or related). We are open on background and degree for the right operator.
• Experience with a federal sponsor that uses active program management (ARPA-H, DARPA, IARPA, BARDA, or similar) and with milestone-based, go/no-go funding structures.
• Multi-site study coordination and management of subawards or multi-institutional partnerships.
• Familiarity with fertility care, reproductive medicine, environmental health, or exposome science.
• Experience with LIMS or biospecimen tracking systems and with cold-chain or biobanking logistics.
• Evidence of having grown a program's scope, headcount, or funding over time.

What success looks like

At six months, specimen and data pipelines are running across the three currently identified CUFC clinical sites (Manhattan, White Plains, and Teaneck), of the full program structure; the regulatory file is complete and audit-ready; the first ARPA-H milestone report has been delivered on time; and Dr. Williams is spending his time on science rather than operations. At twelve months, national partner sites and the VA cohort are enrolling under a harmonized protocol, Phase 2 studies are staffed and approved, and ARPA-H regards the Columbia team as the program it does not have to worry about. Over the life of the program, you are the person the sponsor, the PI, and partners rely on to know exactly where things stand, catch problems early, and keep the study growing in scope and rigor as it succeeds.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.