Telix Pharmaceuticals Limited एक वाणिज्यिक चरण की जैव-औषधि कंपनी है, जो कैंसर और दुर्लभ रोगों के लिए थेरानोस्टिक रेडियोफार्मास्यूटिकल्स विकसित और व्यावसायीकृत करती है। इसका दृष्टिकोण लक्षित इमेजिंग को विकिरण-आधारित उपचार के साथ जोड़ता है, ताकि अधिक सूचित नैदानिक निर्णय और व्यक्तिगत देखभाल में सहायता मिल सके।
कंपनी की पाइपलाइन में प्रोस्टेट और किडनी कैंसर, न्यूरो-ऑन्कोलॉजी और मस्कुलोस्केलेटल कैंसर शामिल हैं। Telix ने अपने प्रमुख इमेजिंग उत्पाद Illuccix® के लिए वैश्विक नियामकीय अनुमोदन प्राप्त किए हैं और दुनिया भर में क्लिनिकल परीक्षणों के व्यापक कार्यक्रम को आगे बढ़ाना जारी रखा है। इसकी टीम स्वास्थ्य सेवा, जैव-प्रौद्योगिकी और संबंधित वाणिज्यिक क्षेत्रों में मिलकर काम करती है, ताकि रेडियोफार्मास्यूटिकल नवाचारों को विकास से क्लिनिकल उपयोग तक पहुंचाया जा सके।
Associate Director, Clinical Operations (Remote, US)
Lead global clinical-trial operations at Telix Pharmaceuticals, a radiopharmaceutical company focused on precision medicine. Oversee studies, CROs, budgets, compliance, and clinical operations teams.
विवरण
- Keep clinical-stage programs on track for their objectives, timelines, budgets, and quality standards.
- Plan and deliver clinical studies from startup through conduct, reporting, and close-out.
- Coordinate project-team work across internal teams, development partners, and CROs.
- Oversee clinical trials throughout their lifecycle.
- Lead and manage clinical operations staff.
- Develop global participant recruitment plans and communicate with study principal investigators.
- Manage CRO and vendor relationships and establish key performance indicators.
- Develop contingency and risk-management plans.
- Support clinical project managers across programs.
- Prepare study budgets, timelines, forecasts, and variance analyses.
- Track study progress through regular communication with CROs and investigator sites.
- Coordinate cross-functional teams to support effective trial delivery.
- Review and complete study plans and systems.
- Contribute to Case Report Form design and user acceptance testing.
- Help develop protocols and informed-consent materials, assessing operational feasibility.
- Oversee study budgets, contracts, payments, and accruals.
- Maintain the Trial Master File and keep studies inspection-ready.
- Support audits and inspections.
- Work with regulatory and medical teams on safety management and monitoring.
- Initiate clinical change-control processes.
- Contribute to SOP development and improvements to departmental infrastructure.
आवश्यकताएँ
- Experience leading and managing clinical trials across their lifecycle.
- Experience planning and executing clinical studies.
- Knowledge of GCP and ICH guidelines.
- Knowledge of regulatory requirements and company SOPs.
- Experience managing multidisciplinary internal and external teams.
- Experience identifying, procuring, and selecting CROs and vendors, and managing their operations.
- Experience developing and managing KPIs.
- Experience with Case Report Form design and user acceptance testing.
- Experience developing contingency and risk-management plans.
- Experience preparing budgets, study timelines, and forecasts.
- Experience overseeing investigator and vendor contracts, budgets, and payments.
- Experience setting up, maintaining, and closing out Trial Master Files and preparing for audits.
- Experience supporting audits and inspections.
- Experience with clinical change-control processes.
- Experience managing, mentoring, and developing staff.
- Ability to collaborate with Clinical, Data Management, Medical Writing, Biostatistics, CMC, Pharmacovigilance, Regulatory, Program Management, CROs, and other stakeholders.
- Strong communication and collaboration skills, adaptability, ethical conduct, and commitment to continuous learning.
लाभ
- Annual performance-based bonus.
- Equity-based incentive program.
- Generous vacation allowance.
- Paid wellness days.
- Learning and development support.
- Hybrid and remote work arrangements.