Job description
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix
The Senior Clinical Project Manager (SCPM) reports to the Senior/Director of Clinical Operations who bears primary responsibility for the execution of Telix’s clinical trials. The SCPM is responsible for the successful execution of national and global clinical trials (early phase to registration) from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, quality, and team management in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The SCPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues.
Key Accountabilities
- Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial timelines, budgets, resources, and vendor relationships from protocol finalization through to study closeout.
- Forecast and identify opportunities to accelerate activities to bring spend forward or identify if spend will shift.
- Independently develop integrated study management plans with the core project team.
- Developing and managing all study-related documents such as study protocol, informed consent, clinical manuals, and implementing quality standards.
- Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
- Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs.
- Managing risks proactively and leading problem solving and resolution efforts
- Support the development and maintenance clinical SOPs & trial process’ as required.
- Developing project delivery strategy for RFPs. Lead in bid defense preparations. Understand project strategy and translate the agreed upon approach.
- Management of complex multi-national, multi-center clinical research projects
- Develop patient recruitment strategies
- Conduct contract and budget negotiations with sites and vendors
- Communicate trial status, issues, and mitigations to leadership and relevant cross-functional stakeholders
- Train study team members and act as mentor for CPMs
- Work independently with limited supervision
- Attend medical conferences and represent clinical operations through investigator engagement and/or presentations
Education and Experience
- A minimum of a Bachelor’s degree in life sciences, PMP preferred
- At least 5 years of relevant experience in Clinical Trial Project Management.
- Experience with late phase clinical trials (Phase 3 - 4, registration trials), oncology and/or radiopharmaceutical experience preferred.
- Excellent oral and written communication, organizational, and problem-solving skills while working under strict timelines.
- Team oriented mindset and demonstrates ability to work with cross functional teams.
- Experience managing global clinical trials.
- Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes. • Demonstrated ability to pivot study strategy quickly and lead teams in the right direction.
- Strong analytical, organisational, planning, decision making, negotiation, and conflict management skills.
- Fluent in Microsoft Office suite (Word, Excel, SharePoint, Teams, etc.) and experienced in working in mainly electronic record-keeping environment.
- Demonstrated leadership skills and ability to cultivate development of others
- Start-up experience (country and site feasibility, ethics & regulatory submissions in multiple regions (APAC, EMEA, NA)
- Flexibility in work hours that cater to international time zones across the US, Asia-Pacific, and EMEA
- Ability to travel
- Strong focus on quality work
- Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments
Key Capabilities:
- Strong communication skills, effective across all levels of the organization.
- Extensive experience in Regulatory Affairs, particularly with the TGA in Australia, and ideally, experience working with regulatory authorities across the Asia-Pacific region.
- Proficient understanding of both early and late-stage drug development processes, including clinical and non-clinical requirements, at an advanced level.
- Strong ability to collaborate effectively with teams across the region.
- Demonstrate a dedication to continuous learning and professional growth, actively pursuing opportunities to enhance your expertise and skill set.
- Uphold integrity and exhibit a steadfast commitment to ethical conduct in all dealings with colleagues and stakeholders.
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
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