Global VP of Clinical Operations

vedantabiosciences; Cambridge (MA); Hybrid; USD 230,000 - 300,000; Full time

Job summary

Vedanta Biosciences, based in Cambridge, MA, is seeking a Vice President of Clinical Operations (hybrid) to lead our global clinical programs, driving on-time, on-budget execution in line with GCP and regulatory standards.

The leader will oversee CROs and vendors, manage budgets and timelines, mentor the Clinical Operations team, and partner with executives across departments to represent Vedanta exernally in a fast-paced biopharma environment.

Qualifications

• BS, RN, MS degree or higher with 15+ years in pharma.
• 10+ years in Clinical Research or Clinical Operations leadership.
• Extensive knowledge of GCPs; FDA/EMA/ICH guidelines.
• Experience selecting CROs and managing vendor relationships.
• Deep drug development experience in Phases 1-3.
• Strong leadership in a matrix environment; ability to mentor.

Responsibilities

• Provide strategic and operational oversight of clinical trials to ensure on-time, on-budget delivery per GCP and regulatory requirements.
• Develop and manage the Clinical Operations budget and resource forecast.
• Serve as a member of the corporate Operations Leadership Team.
• Ensure goals and objectives of development programs are met with strategic input into planning and execution of trials.
• Develop, maintain, and manage relationships with CROs and other vendors to support clinical trials.
• Ensure inspection readiness of clinical operations.
• Lead, train, and develop the Clinical Operations team.
• Partner with CMC and Clinical Supply teams to ensure adequate and timely clinical supply to sites.
• Collaborate with Medical Affairs on study design, data dissemination strategies, and scientific communication initiatives.
• Oversee preparation of clinical study documents including protocols, investigator brochures, informed consent forms, and study reports; plan investigator meetings.
• Develop and report key executional metrics for oversight of clinical trials.
• Develop and revise corporate SOPs and policies with Clinical Quality Assurance.

Skills

Leadership

GCP knowledge

CRO management

Drug development

Education

BS, RN, MS degree or higher

Job description

Vedanta Biosciences, based in Cambridge, MA, is seeking a Vice President of Clinical Operations (hybrid) to lead our global clinical programs, driving on-time, on-budget execution in line with GCP and regulatory standards.

The leader will oversee CROs and vendors, manage budgets and timelines, mentor the Clinical Operations team, and partner with executives across departments to represent Vedanta exernally in a fast-paced biopharma environment.