Rapport Therapeutics · 21 hours ago
Associate Director, Clinical Operations
99 High Street, Suite 2100 , Boston, MA 02110
Full-time
Hybrid
Lead/Staff, Director/Executive
$185K/yr - $205K/yr
10+ years expRapport Therapeutics is dedicated to developing precision neuromedicines aimed at improving patient outcomes. The Associate Director, Clinical Operations will lead and oversee all clinical trial activities, ensuring compliance with regulatory guidelines and managing vendor relationships throughout the trial process.
BiotechnologyHealth CareLife ScienceMedicalNeurosciencePrecision Medicine
Responsibilities
Ensure all trials are conducted according to relevant ICH/GCP guidelines and applicable local regulations
Responsible and accountable for planning and execution of clinical trials: oversight and directional alignment of timelines, budget, and key deliverables as well as contributing to overall clinical trial strategy
Establish and continuously monitor study timelines and budgets, promptly escalating significant risks or changes, as appropriate
Provide input into and oversee development of clinical plans, detailed study plans and clinical documents (synopses, protocols, ICF’s, IB’s and CSR’s)
Develop and manage study contracts, budgets and timelines
Author/review core study documents including protocol and Informed Consent Forms
Manage CRO, central lab, systems vendors, and ancillary vendors to ensure on target deliverables
Lead internal cross-functional Clinical Study Team meetings and participate in external study related team meetings with vendors
Able to support regulatory strategy and assess trial/program impact from multiple countries
May lead RFP process, budget development, and study forecast/planning including timelines
Manages oversight of clinical monitoring activities including monitoring trip report review and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
Manage team with direct reports within therapeutic area
Clinical Operations lead on cross functional project teams and alliance teams
Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies
Oversee clinical systems and technical integrations for databases, CTMS, eTMF, central reading, and other trial execution and/or data collection platforms
Qualification
Required
10-12+ years of Clinical Operations experience
Experience in the Biotech or Pharma industry required
Proven experience leading global Phase I-III clinical trials, with end-to-end ownership of study execution, timelines, and deliverables
Excellent knowledge and understanding of GCP/ICH and EU Guidelines for conducting clinical trials, and have inspection experience
Excellent communication and organizational skills, with the ability to manage complexity across multiple regions and stakeholders
Demonstrated ownership and accountability, with a genuine care for the work and its impact
Preferred
NDA submission experience a plus
Benefits
Unlimited PTO
Lifestyle spending account
Commuting reimbursement
Company
Rapport Therapeutics
Rapport Therapeutics is a clinical-stage biotechnology company that discovers and develops precision medicines for neurological disorders.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$500MKey Investors
Cormorant Asset ManagementThird Rock Ventures
2025-09-09Post Ipo Equity· $250M
2024-06-07IPO
2023-08-23Series B· $150M
Leadership Team
Troy Ignelzi
Chief Financial Officer
Cheryl Gault
Chief Operating Officer
Recent News
2026-01-08
Company data provided by crunchbase