Senior Global Clinical Lead, Prostate Cancer Therapeutics
Telix Pharmaceuticals Limited
Summary
Join Telix Pharmaceuticals, a fast-growing radiopharmaceutical company, as a Sr. Global Clinical Development Lead in Prostate Cancer. You will lead the design and execution of clinical trials for novel radiopharmaceutical products, ensuring alignment with regulatory requirements and stakeholder needs. This role requires strong leadership, clinical development expertise, and collaboration with cross-functional teams. You will contribute to the advancement of Telix's portfolio of late clinical-stage products addressing unmet needs in oncology and rare diseases. The position offers a unique opportunity to drive clinical development strategy in a high-impact area. Telix provides a supportive and collaborative work environment with competitive compensation and benefits.
Requirements
- Medical degree required
- Clinical experience in medical oncology or nuclear medicine is essential
- 7+ years of experience in clinical development
- Strong knowledge of clinical trial design, methodology, and regulatory requirements required
- Successful leadership and project management of clinical development programs required
Responsibilities
- Lead development of clinical development plans for therapeutic assets in prostate cancer
- Collaborate with global program heads, regulatory affairs, medical affairs, and translational medicine teams to ensure alignment of clinical trial objectives with overall asset strategy
- Develop clinical study plans from concept to synopsis to full protocol, ensuring alignment with the Company’s objectives, and the needs of regulatory authorities, healthcare professionals, patient groups, guidelines committees and payors
- Develop – in collaboration with relevant cross-functional teams and medical writers – clinical study documentation including, but not limited to informed consent documents, imaging charters, study manuals and final regulatory dossiers
- Lead clinical scientific input into documentation including investigator brochures, IMPDs, safety reports (e.g. DSURs, PSURs, and SUSARs), clinical study reports and regulatory documents such as briefing packages, INDs, BLAs, NDAs and MAAs
- Lead the analysis, review, and quality control of clinical data (e.g. study-related, aggregated) including efficacy, safety, and imaging data to ensure accuracy and quality
- Prepare and deliver presentations, proposals, and reports for senior management, partners, and other stakeholders
Preferred Qualifications
Experience with regulatory submissions (e.g., IND, CTA) and interaction with regulatory agencies (e.g., FDA, EMA) is preferred
Benefits
- Competitive salaries
- Annual performance-based bonuses
- An equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote employees located all around the world