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Senior Director, Sponsor Oversight and Monitoring Effectiveness

Dyne Therapeutics · Waltham, MA · On-site

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About Dyne Therapeutics

Repairing muscle, reclaiming now. Life-transforming therapies for inherited muscle diseases. Backed by Atlas Venture.

About the role

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • Bachelor’s degree in a life science, nursing, or related field required. Advanced degree (Master’s, PharmD, or PhD) or RN licensure preferred
  • 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
  • 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
More about this role

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .

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 leader develops the operating model, standards,...

Read the full posting on Dyne Therapeutics's site ↗

GL - Clinical Operations

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