Head of US Clinical Operations, Global Medical

Ipsen; Cambridge (MA); On-site; USD 215,000 - 315,000; Full time

Job summary

An established industry player is seeking a Head of US Clinical Operations to lead and oversee evidence generation activities. This pivotal role involves strategic alignment with global medical objectives, direct leadership of the US team, and collaboration with international counterparts. The ideal candidate will have extensive experience in pharmaceutical development, strong project management skills, and a deep understanding of regulatory compliance. Join a dynamic environment that values innovation and teamwork, where your expertise will directly impact clinical development goals and enhance patient outcomes.

Benefits

401(k)

Health Coverage

Parental Leave

Comprehensive Benefits

Qualifications

• Significant experience in pharmaceutical drug development or medical affairs.
• Proven leadership experience in managing teams.

Responsibilities

• Lead the US clinical operations team and collaborate with global teams.
• Manage relationships with sites and KOLs to facilitate study progress.

Skills

Clinical Study Design

Project Management

Regulatory Compliance

Leadership

Communication Skills

Education

Bachelor’s degree in life sciences

Master’s degree

Job description

Head of US Clinical Operations, Global Medical

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Job Overview

The Head of US Clinical Operations, Global Medical is responsible for leading and overseeing evidence generation activities within the US, ensuring strategic alignment with global and local medical objectives. This role involves direct leadership of the US team, collaboration with global teams, vendor oversight, and maintaining relationships with key external stakeholders such as sites and KOLs. The position requires ensuring compliance, managing resources, and providing strategic guidance to support Ipsen's medical and clinical development goals.

Key Responsibilities

• Lead the US clinical operations team and collaborate with global teams to ensure timely and high-quality evidence generation activities.
• Provide expertise in clinical study design, execution, and compliance, ensuring adherence to GCP and relevant regulations.
• Manage relationships with sites, KOLs, and internal stakeholders to facilitate study progress and issue resolution.
• Oversee project management aspects, including timelines, budgets, and KPIs, to ensure successful study delivery.
• Ensure documentation and inspection readiness, maintaining high standards of compliance and quality.
• Serve as a key liaison between US Medical Affairs and global teams, providing updates and escalating issues as needed.
• Manage vendor relationships and oversee external service providers involved in studies.

Qualifications and Experience

• Significant experience in pharmaceutical drug development or medical affairs studies, with project management expertise.
• Proven leadership experience, including managing teams and working within matrix organizations.
• Deep knowledge of GCP, data regulations, and clinical trial processes.
• Bachelor’s degree in life sciences required; Master’s preferred.
• Excellent communication skills in English, both written and oral.

Additional Information

Salary range: $215,000 - $315,000, with eligibility for incentive programs. Ipsen offers comprehensive benefits, including 401(k), health coverage, parental leave, and more. Travel within the US is expected as part of the role.