Senior Director, Sponsor Oversight and Monitoring Effectiveness

The Senior Director, Sponsor Oversight and Monitoring Effectiveness (SOME) is the founding leader of this function within Clinical Operations. This leader sets oversight strategy, designs risk-based monitoring approaches, and provides oversight capacity, including its forecasting. The role safeguards investigator site quality and confirms key vendor activities, and CRO monitoring meets the highest standards of quality, compliance, and patient focus. This role is based in Waltham, MA.

Responsibilities

Design and establish Dyne's sponsor oversight and monitoring effectiveness operating model, including governance, SOPs, templates, training, and capacity planning aligned with ICH GCP; Create and implement Study-Specific Oversight Plans (SSOPs) covering CRO monitoring and key vendors; Establish standards for assurance, escalation, and targeted intervention; Serve as Clinical Operations' accountable owner for sponsor oversight of CRO monitoring and key vendor performance during audits and regulatory inspections; Set Dyne's monitoring standards using quality by design and RBQM, including critical-to-quality factors, KRIs, QTLs, and centralized monitoring; Shape CRO monitoring plans during protocol development and study start-up; Analyze site and study risk, identify emerging issues, and drive timely intervention and corrective action; Establish and track monitoring-effectiveness metrics; Shape the monitoring model as Dyne transitions to a hybrid outsourcing model; Safeguard quality at investigator sites through risk-based surveillance, aggregate data review, and targeted Sponsor Oversight Visits (SOVs); Develop a portfolio-level view of site, study, CRO, and key vendor risk; Communicate oversight findings to study teams, CROs, key vendors, and Clinical Operations leadership; Define and monitor CRO, FSP, and key vendor expectations; Partner with cross-functional teams to integrate operational, clinical, and quality data into actionable risk signals; Report portfolio oversight status, trends, risks, and recommendations to leadership and governance forums; Model Dyne's values and leadership expectations

Requirements

Bachelor's degree in a life science, nursing, or related field; 12+ years of progressive responsibility in clinical operations at a biotech, pharma, or CRO, including at least 5 years leading people managers or functional teams; Hands-on monitoring experience as a Clinical Research Associate (CRA) or monitoring manager, plus direct experience overseeing CRO monitoring; Proven delivery of RBQM, centralized monitoring, or quality-by-design programs; Deep working knowledge of ICH E6(R3), ICH E8(R1) General Considerations for Clinical Studies, and FDA and EMA expectations for sponsor oversight of CROs and other service providers; Experience managing a CRO, or other key vendors: scope, metrics, invoices, and forecasting; Direct experience overseeing key clinical trial vendors beyond the CRO, such as central laboratories, imaging, physical therapy, and other providers; Direct experience hosting or supporting regulatory inspections; Executive presence, with a record of turning risk signals into clear recommendations for senior leaders; Demonstrated experience building capabilities and leading direct reports, subject-matter experts, consultants, or matrixed teams; Ability to travel (generally less than 50%, including local, regional, and international)

Nice to have

Advanced degree (Master's, PharmD, or PhD) or RN licensure; Experience establishing a new sponsor oversight, RBQM, or centralized monitoring capability; Experience with global Phase 2/3 or registration-enabling studies; Rare disease, pediatric, neuromuscular, or genetic-medicine experience; Experience operating in a hybrid outsourcing model; Experience with RBQM platforms, clinical analytics, CTMS, EDC, and eTMF data; Experience evaluating CRA capacity, quality, and monitoring-model effectiveness; Experience with FDA BIMO or comparable global GCP inspections; Experience supporting major regulatory submissions