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Director, Clinical Operations

Job Code: MB-MMB-115

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MarvelBiome, Inc. is a clinical-stage biopharmaceutical company with a vision to harness the power of microbes to treat a range of human diseases. The company is founded over years of advanced scientific research conducted by the co-founders at Massachusetts General Hospital/Harvard University, Boston, MA, including one co-founder who is a recipient of 2024 Nobel Prize in Medicine.

 

About the Job:

We are seeking a Director of Clinical Operations with extensive experience in strategic oversight and accountability for the delivery of specific clinical development programs. This role provides leadership to all operations functions involved in the implementation of clinical projects and represents clinical development functions. The Director is responsible and accountable for the operational strategy and overall execution of assigned clinical program(s), ensuring all activities are performed according to quality, schedule, and cost standards established by the MarvelBiome leadership team, and standard operating procedures.

 

Responsibilities:

  • Lead and oversee end-to-end clinical operations across all programs, ensuring inspection-ready, high-quality execution from study start-up through closeout.

  • Develop and maintain integrated clinical trial timelines and operational roadmaps aligned with corporate strategy, program objectives, and key development milestones.

  • Partner with executive leadership and cross-functional teams to translate clinical development strategy into actionable operational plans.

  • Provide strategic oversight of CROs, vendors, and clinical trial sites, including identification, qualification, selection, onboarding, and performance management.

  • Serve as the primary operational lead for external partners, ensuring adherence to timelines, deliverables, budget, quality expectations, and contractual obligations, including SOWs, proposals, and change orders.

  • Lead study start-up and trial execution activities, including feasibility, site selection, enrollment planning, risk management, and vendor oversight.

  • Oversee clinical trial budgets, resource planning, forecasting, and financial reporting, ensuring cost control and alignment with corporate goals.

  • Establish and drive risk-based operational strategies to proactively identify, escalate, and mitigate study risks impacting quality, timelines, and patient safety.

  • Monitor study progress through KPIs, KRIs, dashboards, and other trial metrics to enable data-driven decision-making and continuous improvement.

  • Collaborate closely with biostatistics to plan, review, and ensure the quality and timely delivery of statistical and data outputs (including TLFs and SAPs) to ensuring accurate integration into the TMF, clinical study reports, and regulatory submission documents

  • Build, optimize, and maintain Clinical Operations infrastructure, including SOPs, processes, workflows, governance, and scalable operating models.

  • Ensure compliance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements, and contribute operational input to regulatory submissions and agency interactions.

  • Partner with Quality Assurance and Regulatory Affairs to support audits, inspections, CAPAs, and ongoing inspection readiness.

  • Evaluate and implement CTMS, eTMF, EDC, and other clinical systems and technologies to support efficient, scalable, and compliant trial execution.

  • Act as a key strategic and operational partner to the Chief Medical Officer, driving execution of the clinical development plan across programs.

 

Qualifications: 

  • A minimum of 7+ years of prior experience in managing clinical trials and program teams, encompassing both early and late-phase programs.

  • Advanced knowledge of drug development principles, clinical trial implementation, and management.

  • Strong project management capabilities with demonstrated success in overseeing global CROs and other third-party vendors or functional service providers in clinical trial execution.

  • Proficiency in ICH GCP and a solid grasp of global regulatory prerequisites.

  • Exceptional time management, interpersonal, communication, decision-making, presentation, and organizational skills.

  • Ability to align operational strategies with company goals and ensure execution excellence.

 

Compensation:

The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for equity compensation and a benefits package.

  

Per Year Salary Range:

$170,000 — $210,000 USD, plus Equity

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