See Yourself at Telix

As a Medical Monitor, your goal will be to contribute to the achievement of the Company’s strategic goals through the management and development of the Regional medical function which is responsible for the medical oversight of Company-sponsored clinical trials (Phase 1-4), Investigator-Initiated trials (IITs), expanded access programs (EAPs) and compassionate use programs (CUPs) to ensure that the clinical data supports the study objectives and meet development milestones of Telix’s product portfolio.  You will ensure that all medical study activities are conducted within the required timelines and budget, are compliant with ICH guidelines, Good Clinical Practice (GCP) and according to relevant regulatory guidelines, laws and Standard Operating Procedures (SOPs).  To represent the Deputy CMO and Group CMO in the Region working closely with the Clinical Development Leads, Regional leadership, scientific and commercial partners in all product development-related medical activities.

Key Accountabilities:

• Regional medical monitoring activities such as medical review of study data, assessment, and interpretation of clinical and safety data to ensure that data is correct and presented with the appropriate medical interpretation.
• Ensure that all studies are being conducted in compliance with the study protocol and regulations.
• Develop and provide medical input into study documentation including, but not limited to, informed consent documents, regulatory submissions, study protocols, investigators brochures, clinical study reports, patient narratives and safety reports, Protocol Deviation Plan, Safety and Data Review Charters, Safety Management Plans.
• Review and analysis of aggregated clinical trial data to identify patterns, trends, outliers, and potential safety signals and where necessary develop corrective strategies and actions.
• Develop and maintain relationships with KoLs and investigators in the region.
• Provide support to all clinical trials by participating in Investigator Meetings and SIVs.
• Provide site identification lists for further clinical trial site selection and feasibility.
• Assist the study team with recruitment efforts, as required.
• Represent Telix with regional clinical sites, commercial and scientific partners.
• Business partnership functions appropriate for a senior clinical role, including competitive analysis, market / product intelligence, support in partnering and collaboration discussions and treatment landscape analysis.
• Participation in the review and business case development for new pipeline opportunities, production indication expansion, etc.
• Support due diligence activities in collaboration with business development.
• Work with development partners as the key medical person.
• Work in collaboration with clinical science and medical affairs to develop product advisory boards lead advisory boards steering committees and with global thought leaders in appropriate indications and build a regional network of key thought leader relationships.

Education and Experience:

• MD, MBBS or MBChB or equivalent Medical Degree is required.
• Additional Board certification in oncology, hematology, nuclear medicine, radiology or medical oncology is preferred.
• Prior radiopharmaceutical experience preferred.
• 5 years minimum experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs.
• A proven success record in providing medical oversight of Phase 1-4 clinical research studies.
• Demonstrated ability to function in a collaborative, cross-functional matrix environment to develop clinical assets.
• Ability to communicate medical/clinical concepts by preparing clearly written documentation and via presentation.
• Knowledge of relevant regional regulations such as FDA, EMA, TGA, PMDA regulations and guidelines, and experience in interactions with health authorities is essential.
• Experience with, or strong knowledge of oncology drug development.
• Experience or knowledge of orphan or genetic rare disease drug development is desirable.
• Excellent knowledge of the competitive environment for drugs in the oncology marketplace and in research and development pipelines.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills