Program Manager of Therapeutic Development
1 day ago
San Francisco
Job DescriptionAbout Violet Research Institute Violet Research Institute (VRI) is building the future of personalized medicine for patients with genetic diseases. We're at the frontier of a new era in medicine — one where treatments can be designed for individual patients based on their unique biology. Recent breakthroughs in science, engineering, and regulatory pathways have made this possible, but much of this work remains nascent and distributed across disparate efforts globally. We're unifying, refining, and scaling these efforts into a cohesive platform. For each patient we serve, we deeply understand their biology, then design and manufacture a targeted treatment that can be delivered in months instead of years. We combine the urgency and execution mindset of a startup with the mission-driven openness of a nonprofit, allowing us to collaborate broadly and move quickly on behalf of the patients we serve. We've brought together leading researchers, engineers, and organizations across omics, therapeutic design, manufacturing, clinical care, and AI to move from insight to action as quickly as possible. VRI is founded by the family of our first patient, Violet, and is led by Michael Buckley, Siranush Babakhanova and Steve Turner. Our team is deeply cross-disciplinary and first-principles driven. We value builders, experts, and generalists who are excited to work across domains, challenge conventional approaches, and increase access to personalized medicine. What VRI Is Violet Research Institute is a Wyoming-based nonprofit (501(c)(3) determination pending) developing curative therapies for SYT1 Neurodevelopmental Disorder, an ultra-rare neurological condition caused by a dominant-negative mutation in the SYT1 gene encoding Synaptotagmin-1. There are approximately 100 patients globally. Our lead program, VRI-ASO-1, is an intrathecal allele-selective RNase H gapmer ASO (2'-MOE, 5-10-5 architecture) targeting the pathogenic allele via targeting a cis intronic deletion. We went from a family genetic diagnosis to human-dose manufacturing launch in three months. We have a pre-IND under FDA review, parallel regulatory paths in the UAE and Europe, a 300+ candidate ASO screening campaign with lead candidates in rat toxicology, and human-dose manufacturing underway at SynOligo. Our scientific advisory network includes former Ionis, Alnylam, and Denali leaders. We are not a typical nonprofit. We operate at biotech speed with biotech rigor, funded by private philanthropy with no institutional bureaucracy. Why This Role Exists VRI was built in an emergency. The organizational model that got us from zero to manufacturing in 90 days — founder-driven, network-heavy, parallel-everything — is now the bottleneck to the next phase. We have strong science leadership (CSO with 25+ years including PacBio founding), a deep bench of specialist consultants, and an extraordinary operations team. What we lack is a single person who owns the integrated critical path from lead candidate selection through IND filing and first-in-human dosing. Today, cross-functional program integration defaults to our Executive Director, who is simultaneously managing scientific strategy, external partnerships, regulatory geography decisions, recruiting, and CRO relationships. Our CSO spends time on operational tracking that should be beneath his scientific role. Our Head of Research is managing vendor sourcing alongside preclinical study design. These are misallocations of exceptional talent. The person in this role fixes that by owning the connective tissue between workstreams so that scientists do science and leadership does strategy. Reporting StructureReports ToScopeWhat You ProvideSteve Turner — Chief ScientistScience StatusConsolidated view of every workstream: compounds in screening, tox data status, manufacturing progress, CRO deliverables on track vs. at risk. Steve should never have to chase down operational status himself.Siranush Babakhanova — Executive DirectorStrategic ExecutionTranslate strategic decisions into operational plans and timelines. Build operational infrastructure for new collaborations. Flag when operational constraints should change strategic direction.What You'll Own — The Budget — You maintain a rolling view of all VRI spending: CRO contracts, manufacturing runs, consultant fees, material procurement, equipment, and travel. You know what's committed, what's forecasted, and what's at risk. You present a clear financial picture to Michael on a regular cadence and flag any spend that needs approval before it's committed. — The Integrated Program Timeline — You build and maintain a single source of truth for VRI-ASO-1's critical path — from ASO lead selection, through rat toxicology completion, in vitro tox battery, CMC, IND filing, and first dose. Even though we have already decided on at least 2 candidates that we are manufacturing, the data may come back requiring us to switch a candidate even after patient dose 1, so VRI-ASO-1 needs additional plan B ASOs for the same program in play. Every workstream leader knows what they owe, when, and what depends on it. When timelines slip, you're the first to know, and you've already identified the mitigation. — Nucleic Acid Drug Development Oversight — As PM for all of our nucleic acid drug development, you will additionally oversee: ASO-2 program (modified chemistry e.g. LNA, architecture e.g. 3-8-3, backbone e.g. PN moieties); ASO-3 shuttled ASO approach (derivative from ASO-1 and ASO-2); siRNA-1 (in collaboration with external design and screening partners); and potentially VRI-COMB-1 (combination therapy for siRNA and ASO together). — CRO Accountability — VRI works with 10+ external partners across screening (La Jolla Labs), neuronal assays (iXCells), toxicology (BioLegacy, Wuxi NJ), manufacturing (SynOligo), bioanalytics (WuXi), and others. You own the master schedule of deliverables, incoming data, quality checks, and escalation when CROs underperform. You know what's arriving when, from whom, and whether it meets spec. — Cross-Functional Data Flow — ASO screening data must flow into lead selection decisions and be influenced by our Clinical Advisory Board and Lead Consultants whom you need to help manage relationships with. Lead selection must trigger manufacturing sequences. Tox data must flow into the IND package. Bioanalytical results from rat studies must inform dose selection for the clinical protocol. Today, these handoffs happen through Slack messages and ad hoc meetings. You turn them into a system. — IND Package Assembly — Working with our regulatory lead (Kennedy Brooks) and CSO (Steve Turner), you ensure every section of the IND — nonclinical pharmacology, toxicology, CMC, clinical protocol — is being drafted, reviewed, and finalized against a shared timeline. You don't write the science, but you make sure the scientists' work lands in the right format, on time, in the right section. — Resource and Material Tracking — At any given time, VRI has ASO compounds at multiple sites, cell lines in various stages of expansion and differentiation, rat studies in progress, and manufacturing runs underway. You maintain visibility into what material is where, what's being consumed, and what needs to be ordered or shipped. You own or directly oversee the sample tracking system. What You Don't Own — Scientific Decisions — Steve and Siranush (with support of the rest of the scientific team) make decisions about which nucleic acid compounds to advance, what tox endpoints matter, and what the clinical protocol says. You provide them with the operational context and complete status picture to make those decisions well and on time — but you don't make the calls. — Strategic Direction — Siranush determines which regulatory geographies to pursue, which partnerships to activate, and how to allocate resources across VRI's portfolio. You execute the operational plan those decisions generate, and you push back when operational reality should change the strategy. — External Partnerships — Siranush manages relationships with Lilly, n-Lorem, academic collaborators, and funders. You may attend those meetings for operational context, but relationship management is not your role. What This Requires — Direct experience running IND-enabling programs in oligonucleotide or RNA therapeutics. This is not negotiable. You need to have personally managed the operational complexity of taking an ASO, siRNA, or similar modality from lead optimization through IND filing. You know what a CMC section looks like, what rat tox study reports contain, what FDA expects in a pre-IND package, and what goes wrong at each stage. Ionis, Denali, Alnylam, Arrowhead, n-Lorem, or similar lineage strongly preferred. — CRO management at scale. You've managed 5+ concurrent vendor relationships, held CROs to timelines, and caught quality problems before they became program problems. — Program budget ownership. You've directly managed a multi-million dollar preclinical or clinical development budget — not just tracked spend, but owned the forecasting, variance analysis, and trade-off decisions about where to allocate limited resources across competing workstreams. — Comfort with a founder-driven, high-speed, messy environment. VRI is three months old with ~30 team members, most part-time or consulting. There is no ERP system, no formal SOPs for most processes, no PMO. You are building the operating system while the plane is in flight. — Ability to work directly with world-class scientists without intermediation. Our CSO founded PacBio. Our Head of Research spent 8 years at Alnylam. Our advisors include former Ionis VP-level scientists. You need to earn their trust by demonstrating operational competence and scientific fluency — not by pulling rank. — Physical proximity or willingness to travel. Key sites are in the San Francisco Bay Area (Glyphic Biotechnologies), San Diego (La Jolla Labs, iXCells, BioLegacy, Wuxi NJ), and New York (Cornell, Mt Sinai, clinical site). Remote work is fine for day-to-day, but you must be willing to be on-site when it matters. — Comfort with AI and modern tools. At VRI we truly embrace using AI at every step of the process and constantly adopt better new tools that emerge. Comms on Slack and email, Claude and other AI integrations used 24/7, vibecoding with Claude or Perplexity custom tooling to manage your work required, automated reporting when prompted should be easy because all notes, conversation notes, chats should be all integrated with AI at all times. How to Think About This Role If you've spent your career at large pharma and are used to managing one workstream within a 200-person program team, this will overwhelm you. If you've been at a 20–50 person biotech where you were the person who made sure everything came together for an IND filing — where you were the one who knew that the tox report was three days late and the CMC section needed one more round of QC and the clinical site agreement wasn't signed yet — then you already know what this job is. The patient is an infant. The disease is progressive. The science is strong. The team is extraordinary. What's missing is you. Compensation The estimated US base salary range for this full-time position is $120,000-$220,000 + Benefits. This is a mission-driven nonprofit; the compensation reflects the urgency and importance of the work, not a startup equity play.