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Vice President, Clinical Operations

Lantheus
Bedford, MA Full Time
POSTED ON 1/16/2025
AVAILABLE BEFORE 4/13/2025

Description

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of Role

We are seeking a highly skilled and experienced Vice President of Clinical Operations to lead and oversee our clinical trial portfolio.

Key Responsibilities / Essential Functions

  • Leadership and Strategy :
  • 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.
  • Clinical Trial Oversight :
  • 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.
  • Collaboration with Internal and External Stakeholders :
  • 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.
  • Team Development :
  • 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.
  • Regulatory Compliance and Quality Assurance :
  • 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.
  • Budget Management :
  • 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.

Basic Qualifications :

  • 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.
  • Other Requirements

  • This position is site-based and requires a presence on-site of 3 days per week in Bedford, MA when not traveling.
  • Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Any applicant requiring an accommodation in connection with the hiring process and / or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com .

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