https://www.linkedin.com/jobs/view/3962247485
Global Product Development Lead - TLX592 (Geneva, Switzerland)
The Program Lead will be responsible for the successful development of a Prostate-Specific Membrane Antigen (PSMA)-targeted therapy up to and including Phase 2 clinical trials. The role will be responsible for creating, implementing, managing and executing the drug development plan. The successful delivery of the development plan will require leading a cross-functional team including manufacturing, non-clinical, clinical, quality and regulatory and a strong understanding of oncology drug development.
Work as part of a cross-functional team to create product development and commercialisation plans for the PSMA-targeted therapy product.
Lead cross-functional teams to deliver the program and product development milestones up to the end of Phase 2 clinical evaluation.
Complete oversight of the successful delivery of product development plans and product approvals, more specifically:
Successful execution of all product development plans through to the end of Phase 2 clinical evaluation within project timelines and budget.
Oversight of Project Manager to ensure application of project management best practice, with the objective of progressing the Telix product portfolio through development within project timelines and budget.
Maintenance of up-to-date documentation of product positioning and target product profile.
Progress tracking of all activities against the development plan and notification of potential delays and/or other changes.
Documentation and tracking of the Program budget; working with Finance and the project manager to ensure contracts and costs are recorded in an accurate and timely manner.
Work with senior management to assess product development risks and compile risk mitigation and scenario plans
Conducting regular reviews to ensure appropriate Program documentation is in place and to monitor project progress, scope, timelines and budget.
Ensuring all Program Team members and the Executive are kept informed of project status, costs and risks.
Supporting Project Managers in preparing periodic reports to internal stakeholders, including senior management, on the status and progress of the Program.
Contribute to the definition and delivery of Corporate Objectives.
Preparing timely and accurate reports for Management.
Maintaining current awareness of Program-related scientific, clinical and commercial functional knowledge.
Postgraduate qualifications in science or life sciences
Minimum 5 years’ pharmaceutical/biotechnology industry experience including direct experience in drug development
An understanding of the regulatory environment in the US, EU and APAC
Experience working as part of, and managing, a cross-functional team
Line management experience
Minimum 5 years’ project and budget management experience
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