Director of Clinical Operations

3 weeks ago

Boston, United States EPM Scientific Full time

Director of Clinical Operations


Company Overview

We are representing an innovative, clinical-stage biopharmaceutical company focused on developing transformative therapies for patients with autoimmune diseases. Our mission is to harness the body's natural mechanisms to re-balance immune responses, addressing the root causes of chronic autoimmune conditions. Unlike traditional therapies, our approach aims to provide a safer, more effective solution without the long-term side effects or risks often associated with immunosuppressive treatments.


As an early-stage, rapidly growing company, this role provides a unique opportunity to make a significant impact while earning an equity position. Join a dynamic and collaborative team of industry veterans and forward-thinking scientists to help transform how autoimmune diseases are treated.


Position Overview:

The Director of Clinical Operations will oversee the implementation and management of multiple clinical trials, ensuring they are executed on time, within budget, and in compliance with regulatory requirements. This role involves leading vendor relationships, building operational infrastructure, and collaborating with cross-functional teams to support the company’s clinical development strategy. Reporting to the VP of Clinical Operations, the Director will play a pivotal role in the success of the organization’s programs.


Key Responsibilities:

Clinical Trial Execution and Oversight:

  • Develop and execute operational plans for clinical trials, managing timelines, budgets, and resources.
  • Ensure trials comply with GCP, regulatory guidelines, and internal SOPs while meeting corporate goals.
  • Lead the preparation of study documents, including protocols, Investigator’s Brochures, CRFs, ICFs, and study reports.
  • Oversee the selection, contracting, and management of CROs and other vendors to ensure timely and high-quality trial execution.
  • Review and approve vendor budgets and invoices, ensuring alignment with operational plans.
  • Collaborate with patient advocacy groups and external stakeholders to optimize patient recruitment strategies.
  • Build and maintain strong relationships with investigators and site staff to support study enrollment and quality.

Operational Infrastructure Development:

  • Partner with the VP of Clinical Operations to structure the department and create a highly effective clinical operations team.
  • Recruit, manage, and develop clinical operations staff to ensure the department’s success.
  • Establish and maintain SOPs, ensuring compliance with ICH-GCP, FDA regulations, and industry best practices.
  • Evaluate and implement innovative tools and processes to enhance trial efficiency and data quality.
  • Collaborate with senior leadership to align clinical operations goals with corporate objectives.

Compliance and Training:

  • Ensure all monitoring activities, study-related processes, and staff training are compliant with regulatory and company standards.
  • Oversee regulatory submissions and approvals, including IRB/IEC and country-specific requirements.


Experience, Skills, and Education:

  • Bachelor’s degree in life sciences or related field; advanced degree preferred.
  • Minimum of 8+ years of clinical operations experience, with strong expertise in managing complex trial designs across multiple phases.
  • At least 4 years of leadership experience in clinical operations, including team and vendor management.
  • Comprehensive knowledge of GCP, ICH guidelines, and global regulatory requirements.
  • Demonstrated ability to manage cross-functional teams and external partnerships effectively.
  • Strong problem-solving, analytical, and critical thinking skills.
  • Exceptional written and verbal communication abilities.
  • Self-starter with excellent interpersonal skills and the ability to build and maintain relationships across all levels.
  • Detail-oriented, with a proven track record of success in high-pressure, fast-paced environments.

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