Director of Clinical Development (Theranostics)

Overview

Responsibilities

• Lead the design and clinical implementation of Phase I through Phase III trials for theranostic products.
• Oversee the preparation of clinical trial protocols and investigator brochures for regulatory submissions.
• Collaborate with dosimetry experts to establish appropriate dosing regimens for radioligand therapies.
• Manage relationships with key opinion leaders in nuclear medicine and oncology to support program objectives.
• Review and interpret clinical trial data to ensure patient safety and demonstrate therapeutic efficacy.
• Provide strategic input for the development of companion diagnostics that identify suitable patient populations.
• Represent the clinical development program during interactions with global health authorities and regulatory agencies.

Qualifications

• A Medical Doctorate or a PhD in a relevant life sciences field is standard for this seniority level.
• Extensive experience in oncology clinical drug development within the pharmaceutical or biotechnology industry is required.
• Deep technical knowledge of radiopharmaceutical science and nuclear medicine procedures is essential.
• Demonstrated success in leading global clinical programs through complex regulatory approval cycles is mandatory.
• Proficiency in clinical data analysis and interpretation of imaging results is necessary for trial oversight.

Nice to have

• Board certification in nuclear medicine or oncology provides a significant competitive advantage.
• Prior experience with FDA or EMA advisory committee preparations is highly beneficial.
• A robust network of existing relationships within the global nuclear medicine clinical community is preferred.

Work environment

• The role is typically hybrid, involving a mix of office-based strategic planning and remote coordination.
• Frequent travel to clinical trial sites and global medical conferences is a standard expectation.
• Team culture is multidisciplinary, involving close cooperation between clinical, regulatory, and supply chain departments.
• Work hours are often irregular due to the global nature of clinical trials and time-sensitive isotope deliveries.
• Operations rely heavily on clinical trial management systems and advanced medical imaging software.

Benefits & growth

• Compensation packages typically include high base salaries supplemented by significant performance-based bonuses.
• Annual equity grants or stock options are standard components of executive-level pharmaceutical roles.
• Career progression paths often lead to Vice President of Clinical Development or Chief Medical Officer positions.
• The field offers extensive opportunities for professional development through participation in international scientific committees.
• High demand for specialized expertise in radiopharmaceuticals ensures strong job security and professional mobility.