Telix Prescribed drugs is a dynamic, fast-growing radiopharmaceutical firm with workplaces in Australia (HQ), Belgium, Japan, Switzerland, and the US. Our mission is to ship on the promise of precision medication by means of focused radiation. At our core, we exist to create merchandise that search to enhance the standard of life for folks residing with most cancers and uncommon ailments. You can be supporting the worldwide roll-out of our authorized prostate most cancers imaging agent and serving to us to advance our portfolio of late clinical-stage merchandise that deal with vital unmet want in oncology and uncommon ailments.
See Your self at Telix
We’re searching for a dynamic and skilled Sr. World Medical Lead in Prostate Most cancers Imaging as a part of our Medical Technique and Innovation staff. The profitable candidate will likely be accountable for designing and executing scientific trials for novel radiopharmaceutical merchandise in prostate most cancers imaging. This place affords a singular alternative to drive scientific growth technique in an space of excessive unmet want.
The Sr. World Medical Lead will make sure the prostate most cancers imaging packages are based on sound scientific decision-making and are capable of be progressed effectively and successfully in direction of industrial realization by producing scientific information to serve the necessities of each inside stakeholders and exterior stakeholders together with, however not restricted to regulatory authorities, healthcare professionals, affected person teams, tips committees, payors, and pharmaceutical and enterprise growth collaborators. The profitable candidate will operate underneath the Precision Medication Enterprise Unit, reporting to the Chief Medical Officer for Precision Medication or Senior World Medical Lead for Precision Medication.
The Sr. World Medical Lead will work carefully in a matrix organisation with the respective World Program Leads, Medical Operations, Medical Affairs, Regulatory Affairs, Manufacturing, Enterprise Unit Heads and different related cross-functional groups to advance Telix Group’s property in direction of the clinic. This will likely be undertaken by way of a deep working data of the prevailing and future aggressive panorama in prostate most cancers.
Key Accountabilities:
- Lead growth of scientific growth plans for imaging property in prostate most cancers
- Collaborate with international program heads, regulatory affairs, medical affairs, and translational medication groups to make sure alignment of scientific trial targets with general asset technique
- Develop scientific research plans from idea to synopsis to full protocol, guaranteeing alignment with the Firm’s targets, and the wants of regulatory authorities, healthcare professionals, affected person teams, tips committees and payors
- Develop – in collaboration with related cross-functional groups and medical writers – scientific research documentation together with, however not restricted to knowledgeable consent paperwork, imaging charters, research manuals and ultimate regulatory dossiers.
- Lead scientific scientific enter into documentation together with investigator brochures, IMPDs, security experiences (e.g. DSURs, PSURs, and SUSARs), scientific research experiences and regulatory paperwork akin to briefing packages, INDs, BLAs, NDAs and MAAs
- Lead the evaluation, overview, and high quality management of scientific information (e.g. study-related, aggregated) together with efficacy, security, and imaging information to make sure accuracy and high quality
- Put together and ship shows, proposals, and experiences for senior administration, companions, and different stakeholders
- Management and oversight of a the precision medication scientific growth staff
Schooling and Expertise:
- PhD or Medical diploma required
- Medical expertise in medical oncology or nuclear medication is crucial
- 7+ years of expertise in scientific growth required
- 5+ years main excessive functioning international matrix groups required
- Sturdy data of scientific trial design, methodology, and regulatory necessities required
- Profitable management and venture administration of scientific growth packages required
- Expertise with regulatory submissions (e.g., IND, CTA) and interplay with regulatory companies (e.g., FDA, EMA) is most popular
Key Capabilities:
- Inclusive mindset: Reveal an understanding and appreciation for variety, and actively work to create an inclusive surroundings the place everybody feels valued and revered
- Creativity and innovation: Possess a willingness to suppose outdoors the field and provide you with distinctive and artistic options to challenges
- Dedication to excellence: Take delight in your work and constantly try for excellence in every little thing you do
- Outcomes-oriented: Pushed to realize objectives and targets, with a powerful concentrate on delivering measurable outcomes
- Moral habits: Act with integrity and reveal a dedication to moral habits in all interactions with colleagues and stakeholders
- Adaptability: Comfy working in a dynamic surroundings, capable of regulate to altering priorities, and prepared to tackle new challenges
- Sturdy communication abilities: Capable of talk successfully with colleagues and stakeholders in any respect ranges, utilizing clear and concise language
- Collaboration: Work successfully as a part of a staff, actively sharing data and experience to realize widespread objectives
- Resilience: Reveal the power to bounce again from setbacks and persevere within the face of challenges
- Steady studying: Present a dedication to ongoing studying {and professional} growth, frequently searching for out alternatives to broaden your data and abilities
At Telix, we imagine everybody counts, we try to be extraordinary, and we pursue our objectives with dedication and integrity. You can be a part of an engaged and supportive group of colleagues who all have a shared objective: to assist folks with most cancers and uncommon ailments reside longer, higher high quality lives. Being a Telix worker means being part of a singular, international, interdisciplinary staff working to ship what’s subsequent in precision medication. We’ve got hybrid and distant workers situated all world wide. We provide aggressive salaries, annual performance-based bonuses, an equity-based incentive program, beneficiant trip, paid wellness days and assist for studying and growth.
Telix Prescribed drugs is an equal alternative employer. We consider certified candidates with out regard to race, shade, faith, intercourse, sexual orientation, gender id, nationwide origin, incapacity, veteran standing, and different legally protected traits.