Executive Director, Head of Clinical Development - Oncology

Lantheus • Bedford, MA

4d • $206,000 - $381,000 • Hybrid

About The Position

The Executive Director, Head of Clinical Development, Oncology is the senior leader responsible for shaping and executing the global clinical development strategy for oncology across the United States and EMEA. This position is based in Bedford, MA and requires a presence on-site of two - three days per week and is open to applicants authorized to work for any employer within the United States.

Requirements

• Doctorate degree in a relevant scientific field; board certification in Nuclear Medicine and/or Radiology. Experience in oncology is highly preferred.
• A minimum of 15 years of experience in drug development, with a proven track record in clinical trial planning and execution.
• Experience in Diagnostic Imaging development.
• Minimum of 8 years’ experience in leading an international Team; track record of success in building and leading teams. Strong managerial experience essential. Candidate must know the regulatory strategies of Diagnostic agent approval
• Deep understanding of regulatory requirements and industry guidelines (FDA, EMA, ICH) related to clinical development.
• Understanding of PET imaging and other imaging modalities is preferred
• Experience in drug development (clinical phases I-IV)
• Strong teamwork skills required to work with a cross functional team, but also ability to work independently
• Results oriented and driven by objectives: initiative, flexibility, good organizational, prioritization and time management skills
• Strong communication, presentation, and interpersonal skills to internal and external stakeholders
• Ability to travel as required
• MS Office skills, especially Word, Excel, and PowerPoint. Image analysis experience strongly preferred

Nice To Haves

• Experience in oncology is highly preferred.
• Understanding of PET imaging and other imaging modalities is preferred
• Image analysis experience strongly preferred

Responsibilities

• Development and execution of the overall strategy for Lantheus’ pipeline in oncology indications.
• Build clinical development capabilities across the US and EMEA teams, ensuring consistent execution and alignment.
• Oversee company sponsored clinical research in oncology indications, including input on study-related documents.
• Supervision of medical and safety aspects of ongoing clinical trials
• Support launch strategies, life-cycle management, and expansion of indications for use (Phase 1-4 studies)
• Provide guidance and support for medical publications
• Liaise with regulatory authorities (early access, compassionate use or registry programs)
• Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan
• Attend relevant scientific meetings and conferences and support development of summaries of key data, presentations, or symposia
• Implementation of applicable guidelines of the quality assurance system of Lantheus
• Ensure compliance with applicable local and global laws, regulations, guidelines and company policies and procedures

Benefits

• comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage.
• life and disability benefits
• pre-tax accounts
• a 401(k) with company contribution
• a variety of other benefits.
• generous time off package including paid vacation, holidays, sick days, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree