Global Clinical Lead

 Posted 2 hours ago
     
5-10 years experience
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AI Summary

The Global Clinical Lead designs and implements the clinical development strategy for therapeutic assets, focusing on protocol design and high-quality data generation. They collaborate across a matrix organization to advance oncology and rare disease products toward commercial realization.

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

The Global Clinical Lead is a significant subject matter expert (SME) role that exists within Telix to design, lead and implement the clinical development strategy for the Company’s Therapeutic assets.  

The Global Clinical Lead will lead the design of therapeutic clinical trials, including but not limited to protocol design, endpoints, eligibility criteria, and statistical plans. Thereby, the Global Clinical Lead, will ensure the therapeutic programs are founded on sound scientific decision-making and are able to be progressed efficiently and effectively towards commercial realization by generating high quality clinical data to serve the requirements of both internal stakeholders and external stakeholders including, but not limited to regulatory authorities, guidelines committees, payors, patient advocacy groups, and relevant business partners.

In this role, the Global Clinical Lead will work closely in a matrix organization with the respective Global Program Heads, Clinical Operations, Regulatory Affairs, Medical Affairs, Therapeutic Business Unit Head and other relevant cross-functional teams to advance Telix Group’s therapeutic assets towards the clinic. This will be undertaken via a deep working knowledge of the existing and future competitive landscape in relevant cancer therapy areas.

Key Accountabilities:

  • Design, lead and implement Clinical Strategy: Define and drive the clinical development plans for Telix’s Therapeutic assets, ensuring alignment with Telix’s broader asset strategy and commercial objectives
  • Cross-functional collaboration: Partner closely with Global Program Heads, Clinical Operations, Regulatory Affairs, Medical Affairs, and the Therapeutic Business Unit Head to ensure clinical trial objectives are integrated into the overall development strategy and reflect the needs of internal and relevant external stakeholders
  • Clinical study design and execution: Oversee the development of clinical study plans from concept through to protocol finalization, ensuring scientific rigor and alignment with regulatory expectations, healthcare provider needs, patient advocacy perspectives, and market access requirements
  • Clinical documentation leadership: Lead the creation and review of essential clinical documentation - including informed consent forms, imaging charters, study manuals, and regulatory dossiers - in collaboration with medical writers and cross-functional teams
  • Regulatory and scientific contributions: Provide expert clinical input into key regulatory and scientific documents, including Investigator Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and global regulatory submissions (e.g., INDs, BLAs, NDAs, MAAs)
  • Data integrity and analysis: Lead the review, interpretation, and quality control of clinical data, including efficacy, safety, and imaging endpoints, to ensure data integrity and support decision-making across the development lifecycle
  • Stakeholder communication: Prepare and deliver high-impact presentations, proposals, and reports for senior leadership, external partners, and strategic collaborators to communicate program progress and clinical insights
  • External engagement and thought leadership: Cultivate relationships with Key Opinion Leaders (KOLs), organize advisory boards, and collaborate with subject matter experts, consultants, and vendors to inform clinical strategy and enhance program visibility.

Education and Experience:

  • Qualifications: Medical degree (MD/MBBS) is required
  • Therapeutic area expertise: Demonstrated experience in Oncologyor Nuclear Medicine is required, with a strong understanding of the clinical and scientific landscape
  • Clinical development experience: 5+ years of industry experiencein clinical development, with a proven track record of leading clinical programs through early-phase development. Experience in early-stage clinical trial design and execution is strongly preferred
  • Regulatory knowledge: Solid understanding of global clinical trial methodology, regulatory frameworks, and submission processes. Experience preparing and submitting regulatory documents (e.g., INDs, CTAs) and engaging with health authorities (e.g., FDA, EMA) is preferred
  • Leadership and project management: Demonstrated success in leading cross-functional teams and managing complex clinical development programs from concept through execution
  • Strategic and scientific acumen: Strong knowledge of clinical trial design, data interpretation, and the ability to translate scientific insights into strategic development plans.

Key Capabilities:

  • Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
  • Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
  • Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
  • Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
  • Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
  • Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
  • Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
  • Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
  • Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
  • Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

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 PRIVACY POLICY HERE

 

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