Senior Director, Compound Development (Radiopharmaceuticals)

Company Description

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

Job Description

We are seeking an experienced Senior Director of Compound Development with specialized expertise in radiopharmaceuticals. You will join a dynamic cross-functional team, shaping the development and execution of our radiopharmaceutical compound strategy. There is exciting potential for future leadership within Sirtex or its affiliates.

Responsibilities:

• Develop and implement comprehensive strategies for the development of radiopharmaceutical products, ensuring alignment with corporate goals and regulatory standards.
• Lead cross-functional teams to manage development projects from pre-IND, to clinical trial execution, and to commercialization, ensuring adherence to timelines, budgets, and quality standards.
• Collaborate closely with regulatory affairs and other stakeholders to prepare regulatory submissions and support interactions with regulatory authorities.
• Establish and maintain relationships with key opinion leaders, investigators, and contract research organizations to facilitate successful project execution.
• Identify and qualify potential suppliers, vendors, contractors, and partners, including CROs, CDMOs, radiopharmacies, and hospitals. Coordinate project operations such as CRO registration, production scheduling, supply management, and logistics. Facilitate communication between external partners and internal teams to ensure smooth project execution.
• Monitor project timelines for accuracy and follow up with internal personnel to ensure milestones are met.
• Monitor and analyze project data, interpreting results to inform decision-making and guide future development activities.
• Oversee the development of essential study documents, ensuring compliance with regulatory guidelines and ethical standards.
• Drive continuous improvement initiatives to optimize development processes and enhance operational efficiency.
• Stay current with advancements in radiopharmaceutical science, research methodologies, and regulatory requirements, integrating new knowledge into development strategies.
• Facilitate general business discussions and project management operations to align team efforts with corporate goals.

Qualifications

• Advanced degree (MD, PhD, or equivalent) in a relevant scientific discipline.
• Extensive experience in pharmaceutical development, with a focus on radiopharmaceuticals or oncology is required.
• Strongly prefer experience with compound strategy and CME with demonstrated program experience from feasibility through Phase III, and/or approval
• Strong understanding of clinical strategy, operations, and regulatory requirements governing clinical research.
• Excellent leadership and communication skills, with the ability to collaborate effectively across multidisciplinary teams and influence key stakeholders.
• Strategic mindset with the ability to think critically, solve complex problems, and make data-driven decisions.
• Demonstrated leadership in driving innovation, fostering a culture of excellence, and promoting a patient-centric approach to drug development.

Preferred Qualifications:

• Bi-lingual English/Mandarin Chinese preferred.
• Board certification or specialization in nuclear medicine or radiology.
• Experience working with radioactive isotopes and imaging technologies commonly used in nuclear medicine.
• Previous experience in ma