Telix Pharmaceuticals Limited ir biofarmācijas uzņēmums komercializācijas posmā, kas izstrādā un komercializē teranostiskus radiofarmaceitiskos preparātus vēža un reto slimību ārstēšanai. Uzņēmuma pieeja apvieno mērķētu attēldiagnostiku ar uz starojumu balstītu ārstēšanu, lai atbalstītu informētākus klīniskos lēmumus un personalizētu aprūpi.
Uzņēmuma izstrādes programma aptver prostatas un nieru vēzi, neiroonkoloģiju, kā arī balsta un kustību aparāta vēzi. Telix ir saņēmis globālu regulatīvo iestāžu apstiprinājumu savam vadošajam attēldiagnostikas produktam Illuccix® un turpina attīstīt plašu klīnisko pētījumu programmu visā pasaulē. Tā komanda darbojas veselības aprūpes, biotehnoloģiju un saistītajās komerciālajās jomās, lai radiofarmaceitiskās inovācijas no izstrādes posma nonāktu klīniskajā praksē.
Senior Clinical Project Manager, Remote (United States)
Lead global clinical trials for Telix Pharmaceuticals’ precision radiopharmaceuticals, overseeing study delivery from protocol finalization through closeout. Coordinate vendors, budgets, risks, and cross-functional teams across complex multinational research projects.
Apraksts
- Oversee national and global clinical trials from protocol finalization through closeout.
- Select vendors and sites, assess feasibility, and manage timelines, budgets, resources, and vendor relationships.
- Forecast spending and identify ways to accelerate work or shift expenditure.
- Create integrated study management plans with the core project team.
- Prepare and maintain study documents, including protocols, informed consent forms, and clinical manuals.
- Track external partners’ quality, timelines, and budget performance.
- Put effective project plans into operation in line with applicable SOPs.
- Anticipate and manage risks, leading teams through problem-solving and resolution.
- Help develop and maintain clinical SOPs and trial processes.
- Shape project delivery strategies for RFPs and lead bid defense preparation.
- Direct complex, multinational, multicenter clinical research projects.
- Create patient recruitment strategies.
- Negotiate site and vendor contracts and budgets.
- Update leadership and cross-functional stakeholders on trial progress, issues, and mitigations.
- Train study team members and mentor clinical project managers.
- Work independently with limited supervision.
- Represent clinical operations at medical conferences through investigator engagement and presentations.
Prasības
- A bachelor’s degree in life sciences is required.
- PMP certification is preferred.
- At least five years of relevant clinical trial project management experience is required.
- Experience with late-phase trials (Phase 3–4 or registration studies), oncology, and/or radiopharmaceuticals is preferred.
- Strong written and verbal communication, organization, and problem-solving skills, including the ability to meet tight timelines.
- Collaborative approach and ability to work across functions.
- Experience managing global clinical trials.
- Thorough knowledge of ICH Good Clinical Practice (GCP) and regulatory processes.
- Ability to quickly adjust study strategy and guide teams effectively.
- Strong analytical, organizational, planning, decision-making, negotiation, and conflict-management skills.
- Proficiency with Microsoft Office, including Word, Excel, SharePoint, and Teams, and experience working primarily with electronic records.
- Demonstrated leadership and ability to support others’ development.
- Study startup experience, including country and site feasibility and ethics and regulatory submissions across multiple regions (APAC, EMEA, and North America).
- Travel of approximately 10% is expected.
Priekšrocības
- Competitive salary.
- Annual performance-based bonuses.
- Equity-based incentive program.
- Generous vacation.
- Paid wellness days.
- Learning and development support.