Clinical Program & Community Manager

About the foundation

NIPBL Therapeutics Foundation is a nonprofit advancing therapeutic development for NIPBL-related Cornelia de Lange syndrome (CdLS). Pathogenic variants in NIPBL, which encodes the cohesin-loading factor, are the most common cause of CdLS, a multi-system developmental diagnosis with no approved treatment.

We set a focused research agenda, fund critical science, and coordinate academic laboratories, clinicians, and biotech partners to advance the most promising approaches toward the clinic. Learn more at nipbl.org.

The opportunity

Lead the operational engine of our clinical and patient-data programs. You will turn the scientific roadmap into well-run studies, manage the budgets, vendors, and CROs behind them, and build the patient-data foundation that future trials will depend on.

What you will own

• Program roadmap and coordination. Develop and track integrated roadmaps across our therapeutic pathways, aligned with data milestones and regulatory filing targets.
• Portfolio and budget management. Manage program budgets and financial forecasting; monitor spend against the approved budget.
• Vendor and CRO management. Lead vendor and CRO selection, RFPs and contract negotiation; manage deliverables and KPIs; serve as the primary point for governance escalation.
• Natural history studies and registries. Direct the operational design, launch, and maintenance of natural history, non-interventional observational and prospective registry studies with existing CdLS initiatives, maximizing retention and longitudinal data.
• Patient data, RWE and data integrity. Oversee integration of EHR, registry, and patient-reported-outcome (PRO) data to regulatory-grade quality, and drive use of natural history data as external control arms in sparse populations.
• Regulatory and study documents. Contribute to the operational sections of regulatory filings (such as IND updates and annual reports); draft templates, protocols, and SOPs; manage IRB submission logistics and document control.
• Family engagement and the Research List. Serve as the primary operational contact for interested families, coordinate outreach with CdLS organizations and study teams, and maintain secure Research List records and consent preferences.
• Stakeholder reporting and communications. Deliver program-level updates, risk-mitigation plans and timeline forecasts; run family research updates and provide grant metrics.

Requirements

• Typically 5 to 7+ years in clinical research, with substantial hands-on experience managing clinical trials and cross-functional teams.
• A bachelor's degree in life sciences, public health, nursing, or a related field.
• Experience managing CROs and vendors, program budgets, and contract deliverables.
• Working knowledge of GCP, human-subjects research, informed consent, IRB processes and sensitive health-data handling.
• Strong project management and clear, compassionate communication with families.

Preferred experience

• Master's degree or PhD.
• PMP or clinical research credentials (such as CCRA or CCRP).
• Non-interventional studies, global patient registries, or using natural history data in regulatory interactions.
• Biomarker, bioanalytical or biospecimen operations.
• Pediatric or neurodevelopmental rare disease.