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Associate Director, Clinical Trial

Job in Boston, Suffolk County, Massachusetts, 02298, USA
Listing for: Draig Therapeutics
Full Time position
Listed on 2026-01-22
Job specializations:
  • Healthcare
    Clinical Research
Job Description & How to Apply Below

Title:
Senior Manager Clinical Trial (open to Associate Director level)

About Draig Therapeutics

Draig Therapeutics is an exciting, rapidly growing clinical-stage biotech backed by a transformative $140 million Series A financing - one of the largest ever in neuropsychiatric drug development. We are pioneering innovative small-molecule therapies aimed at fundamentally transforming the treatment landscape for depression and neurological disorders.

Why Join Draig

At Draig Therapeutics, you’ll join a science-first, mission-driven biotech that is redefining what a small, agile, and deeply collaborative organization can achieve. Backed by strong investors and propelled by a bold CNS discovery pipeline, Draig brings together world-class scientists, a caring culture, and the energy of a company on an incredible growth trajectory. Here, innovation and speed aren’t just encouraged - they’re expected.

You’ll partner closely across Discovery, Nonclinical, and Clinical Development, helping to shape programmes that have the potential to transform patient lives. This is an environment where your voice matters, your expertise has real impact, and your work directly influences how promising molecules move from concept into the clinic. At Draig, you won’t just contribute to groundbreaking science - you’ll help build a biotech with purpose, speed, and heart.

For more info, please visit our website.

Responsibilities

This role provides strategic clinical leadership across the asset’s development program, shaping and executing clinical development plans and individual study designs in line with the overall lifecycle strategy. The position serves as the clinical lead for fully outsourced trials, overseeing sponsor responsibilities for protocol design, medical monitoring, data interpretation, and vendor/CRO performance to ensure studies are conducted in accordance with ICH GCP, regulatory, and internal quality standards.

As a core member of cross-functional asset and project teams, the role partners with clinical operations, regulatory, safety, and biostatistics colleagues to integrate clinical insights into program decisions, drive delivery of key milestones, and maximize the therapeutic potential of the asset.

  • Provide clinical and scientific leadership to asset and clinical project teams, ensuring that study objectives align with the overall clinical development plan.
  • Collaborate with cross-functional partners (clinical operations, regulatory, safety, biostats, CMC, commercial) to design and implement early- and late-phase clinical trials.
  • Develop and optimise key clinical documents, including clinical trial protocols, investigator brochures, informed consent forms, and other core regulatory documents.
  • Review clinical data from ongoing clinical trials to ensure data quality and trial integrity.
  • Interpret clinical, safety, and biomarker data to inform go/no-go decisions, publications, and regulatory submissions.
  • Lead the setup and day-to-day oversight of fully outsourced, full-service clinical trials, ensuring adherence to corporate SOPs, ICH‑GCP, and applicable regulatory requirements.
  • Provide oversight of key outsourced activities, including clinical conduct at sites, data management, statistical analyses, drug supply management, and regulatory submissions.
  • Own clinical budgets and timelines for assigned studies, including forecasting, tracking, and proactively managing risks to ensure delivery against agreed milestones.
  • Prepare and present clear, accurate, and timely reports on clinical trial status, risks, and data quality to senior leadership and governance bodies (e.g., monthly and quarterly updates).
  • Serve as clinical lead for one or more trials/ programs, guiding the work of the clinical team and ensuring alignment with asset and portfolio strategy.
  • Represent the clinical function at asset project teams and, as needed, at Draig leadership or governance meetings, providing a clinical perspective and recommendations.
Education and Experience
  • Bachelor’s degree in a relevant scientific discipline (e.g., Biological Sciences, Psychology, Life Sciences) or equivalent experience in clinical research or drug development.
  • Extensive…
Position Requirements
10+ Years work experience
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