Vice President, Clinical Operations

Lantheus Holdings - Bedford, Town of, MA

Full-time - Executive

Bedford, Town of, MA

Miscellaneous Manufacturing

About the position

Lantheus is seeking a highly skilled and experienced Vice President of Clinical Operations to lead and oversee our clinical trial portfolio. This role involves developing and implementing strategic plans for the clinical operations function in alignment with corporate objectives, leading the clinical operations team in the planning, initiation, execution, and completion of clinical trials, and ensuring compliance with regulatory requirements and industry standards. The position requires oversight of all phases of clinical trial management, collaboration with internal and external stakeholders, team development, regulatory compliance, quality assurance, and budget management.

Responsibilities

• Develop and implement strategic plans for the clinical operations function in alignment with corporate objectives.
• Lead the clinical operations team in the planning, initiation, execution, and completion of clinical trials, ensuring compliance with regulatory requirements and industry standards.
• Oversee all phases of clinical trial management, including protocol development, site selection, patient recruitment, data collection, and analysis.
• Ensure that all studies are conducted efficiently, on time, and within budget while maintaining high-quality standards.
• Partner with senior management of contracted CROs to solve trial problems efficiently and effectively as they arise.
• Collaborate with the Chief Medical Officer, Chief Scientific Officer, Chief Compliance Officer, and other senior management to ensure strategic alignment across departments.
• Build, mentor, and manage a high-performing clinical operations team, fostering a culture of collaboration, innovation, and continuous improvement.
• Identify and conduct training and development to enhance team capabilities and performance.
• Provide expert review and advice as needed on key documents or initiatives.
• Participate in governance of Asset Teams or, if needed, as Clinical Operations representative on a key Asset Team.
• Ensure that all clinical trials are conducted in accordance with Good Clinical Practice (GCP), local regulations, and company policies.
• In partnership with Compliance, implement processes to maintain compliance and enhance the integrity of clinical data.
• Participate as needed in FDA audits.
• Develop and manage budgets for clinical trials, ensuring resources are allocated effectively and efficiently.
• Monitor financial performance and work to optimize costs while maintaining study quality.

Requirements

• Advanced degree (PhD, or PharmD) preferred, with a strong background in clinical research, oncology, or neurology.
• Minimum 10 years of experience in clinical operations, with at least 5 years in a leadership role overseeing clinical trials in the pharmaceutical or biotechnology industry.
• Comprehensive knowledge of regulatory requirements in clinical development, including FDA and EMA guidelines.
• Proven experience managing multidisciplinary teams and collaborating across various functions.
• Excellent communication and presentation skills, with the ability to engage and influence key stakeholders.
• Strong analytical and problem-solving skills, with a results-driven mindset.