Job Title: Vice President / Head of Clinical Operations

Location: Hybrid to the Boston area

Company Overview:

We are a rapidly growing, innovative biotech company dedicated to developing transformative therapies for patients with unmet medical needs. With a robust pipeline spanning from early discovery to late-stage clinical trials, we are focused on advancing science to deliver life-changing treatments. Our collaborative and dynamic environment fosters creativity, accountability, and scientific excellence, offering a unique opportunity to make a meaningful impact.

Position Overview:

We are seeking an experienced and strategic Vice President / Head of Clinical Operations to lead all aspects of clinical development programs. Reporting directly to the Chief Medical Officer, this role will oversee clinical operations, including the planning and execution of clinical trials, vendor and CRO management, and operational excellence. As a critical member of the leadership team, you will drive the strategy and execution required to advance our clinical pipeline through all phases of development.

Key Responsibilities:

• Strategic Leadership:
• Develop and execute clinical operations strategies to support the successful delivery of clinical programs across multiple therapeutic areas.
• Partner with cross-functional leadership to ensure alignment of clinical operations with overall corporate goals.
• Clinical Trial Management:
• Oversee all aspects of clinical trial planning, initiation, execution, and close-out, ensuring studies are completed on time, within scope, and on budget.
• Ensure compliance with regulatory requirements, GCP, and company SOPs.
• Vendor/CRO Oversight:
• Lead the selection, negotiation, and management of CROs and other external vendors to optimize quality, timelines, and cost.
• Build strong relationships with external partners to drive accountability and performance.
• Team Building and Leadership:
• Build, mentor, and manage a high-performing Clinical Operations team, fostering a culture of collaboration and innovation.
• Identify talent needs and drive recruitment to scale the team as the company grows.
• Operational Excellence:
• Drive the development and implementation of best practices, systems, and tools to enhance operational efficiency and scalability.
• Develop and monitor KPIs to track trial progress and proactively identify and address risks.

Qualifications:

• Advanced degree in life sciences or a related field (MS, PhD, PharmD preferred).
• 15+ years of clinical operations experience in the biopharmaceutical industry, including leadership roles in biotech companies.
• Proven track record of successfully managing global clinical trials across all phases (Phase 1-3).
• Experience in building and scaling clinical operations teams in a fast-paced, entrepreneurial environment.
• Strong knowledge of GCP, regulatory requirements, and clinical development processes.
• Exceptional leadership, communication, and organizational skills.
• Ability to thrive in a collaborative, dynamic, and results-driven environment.

What We Offer:

• Competitive compensation package, including base salary, bonus, equity, and benefits.
• Opportunity to lead clinical operations in a company with a promising pipeline and significant growth potential.
• A collaborative and innovative environment where your contributions will directly impact patients' lives.

If you are a strategic, hands-on leader passionate about advancing innovative therapies, we encourage you to apply and become a vital part of our mission to transform patient care.