Global Clinical Development Lead, Neuro-Oncology Diagnostic

October 7, 2024

Telix Pharmaceuticals (EMEA)

Genève

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
We are seeking an experienced Global Clinical Lead as part of our Clinical Strategy and Innovation team to lead clinical development of neuro-oncology imaging assets. This position offers a unique opportunity to drive clinical development strategy and the successful advancement of innovative diagnostic programs in an area of high unmet need.
The Global Clinical Lead will ensure the neuro-oncology diagnostic programs are founded on sound scientific decision-making and are able to be progressed efficiently and effectively towards commercial realization by generating clinical data to serve the requirements of both internal stakeholders and external stakeholders including, but not limited to regulatory authorities, healthcare professionals, patient groups, guidelines committees, payors, and pharmaceutical and business development collaborators.
The Global Clinical Lead will work closely in a matrix organisation with the respective Global Program Leads, Clinical Operations, Medical Affairs, Regulatory Affairs, Manufacturing, Business Unit Heads and other relevant cross-functional teams to advance Telix Group's assets towards the clinic. This will be undertaken via a deep working knowledge of the existing and future competitive landscape in neuro-oncology.
Key Accountabilities:

Lead development of clinical development plans for diagnostic assets in neuro-oncology
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

Education and Experience:

Bachelor's degree plus 10+ years of clinical development within the pharmaceutical or biotechnology space or Advanced degree (e.g., MD, Ph D, Pharm D) in a relevant scientific discipline plus 5+ years of clinical development within the pharmaceutical or biotechnology space required
Radiopharmaceuticals experience strongly preferred
Strong knowledge of clinical trial design, methodology, and regulatory requirements
Successful leadership and project management of clinical development programs
Experience with regulatory submissions (e.g., IND, CTA) and interaction with regulatory agencies (e.g., FDA, EMA) is preferred

Key Capabilities:

Willingness to travel domestically and internationally, as needed
Strong understanding of the nuclear imaging market, products, and technologies
Excellent negotiation, communication, and interpersonal skills, with the ability to build and maintain relationships with diverse stakeholders
Self-motivated, goal-oriented, and able to work independently as well as collaboratively within cross-functional teams

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.
VIEW OUR RECRUITMENT PRIVACY POLICY HERE

We regret to inform you that this job opportunity is no longer available