VP, Clinical Operations & Programs (Hybrid)

Vedanta Biosciences, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 275,000 - 330,000; Full time

Job summary

Vedanta Biosciences, a late-stage biopharmaceutical company, is seeking a Vice President, Clinical Operations in Cambridge, MA (Hybrid). This leader will oversee global clinical programs, manage budgets and timelines, and ensure quality and regulatory compliance across trials.

You will mentor the Clinical Operations team, build strong CRO partnerships, drive study design alignment with Medical Affairs, and ensure TMF readiness for inspections while representing Vedanta externally.

Qualifications

• 15+ years in pharma with 10+ years in Clinical Operations leadership.
• Deep knowledge of GCP, FDA, EMA and ICH guidelines.
• Experience selecting CROs and managing key vendor relationships.
• Proven track record in Phases 1–3 clinical trials and SOP development.
• Strong leadership skills in a matrix environment and team-building.

Responsibilities

• Provide strategic and operational oversight of clinical trials, ensuring on-time delivery, budget adherence, and compliance with GCP, FDA/EMA/ICH guidelines.
• Develop and manage the Clinical Operations budget and resource forecast.
• Lead and mentor the Clinical Operations team, building high-caliber contributors.
• Manage relationships with CROs and vendors, ensuring timely deliverables and risk mitigation.
• Ensure Trial Master File (TMF) readiness and audit preparedness.
• Collaborate with Medical Affairs to align on study design and data dissemination.
• Oversee preparation of clinical study documents and investigator meetings.

Skills

Leadership

Budgeting

Vendor management

GCP knowledge

CRO management

Cross-functional collaboration

Communication skills

Travel readiness

Education

BS, RN, MS or higher

Job description

Vedanta Biosciences, a late-stage biopharmaceutical company, is seeking a Vice President, Clinical Operations in Cambridge, MA (Hybrid). This leader will oversee global clinical programs, manage budgets and timelines, and ensure quality and regulatory compliance across trials.

You will mentor the Clinical Operations team, build strong CRO partnerships, drive study design alignment with Medical Affairs, and ensure TMF readiness for inspections while representing Vedanta externally.