Associate Director- Early Development Lead
vor 2 Wochen
Associate Director - Early Development Lead CSL's R&D organisation is accelerating innovation to deliver greater impact for patients. With a project‑led structure and a focus on collaboration, we are building a future‑ready team that thrives in a dynamic biotech ecosystem. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. We are looking for an Associate Director, Early Development Lead who is a strategic safety leader responsible for designing and implementing safety surveillance and risk management strategies for preclinical and early clinical assets. Apply scientific and medical judgement to analyse safety data, develop risk mitigation plans, and contribute to regulatory submissions. Be the safety representative on research and early development teams, ensuring understanding of regulatory, company, and stakeholder safety expectations. Responsibilities Develop and implement risk mitigation strategies for early development assets (e.g., FIH/Phase 1 studies), ensuring endorsement by CSL Safety Governance. Review and interpret emerging safety data from preclinical and early clinical studies; contribute to aggregate safety data analysis and key safety documents (DSURs, risk management plans). Support the setup and evaluation of preclinical data packages, identify new risks, and determine needs for supplementary data. Respond promptly to regulatory agency safety requests. Ensure risk mitigations are reflected in clinical trial documents (protocols, investigator brochures, informed consent forms). Provide guidance on safety issues and facilitate internal/external safety reviews (e.g., DMCs). Represent GSPV in cross‑functional teams and chair safety management teams. Qualifications PhD degree or medical degree with exposure to basic research work. Minimum 5 years in pharmaceutical/biotechnology industry in a safety or research role. At least 3 years working with early clinical development assets (Phase 1/2, including FIH studies). Subject matter expertise in toxicology, pharmacology, and manufacturing aspects relevant to safety. Previous experience in performing qualitative benefit‑risk assessments. Strong communication skills with the ability to convey complex concepts, seek feedback, and tailor messages to audiences. Exhibit leadership skills like independent thinking, cross‑functional influence, conflict management, and adaptability to diverse situations and cultures. Knowledge in safety signal identification, evaluation, escalation, and risk mitigation. Deep knowledge of PV systems, regulatory frameworks, and safety documentation (e.g., DSURs, RMPs, IBs). How to Apply Please apply with your updated resume. About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life‑saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. #J-18808-Ljbffr
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Associate Director, Early Development Lead
vor 2 Wochen
City of Melbourne, Österreich CSL VollzeitAssociate Director, Early Development Lead Join to apply for the Associate Director, Early Development Lead role at CSL Your Opportunity CSL's R&D organisation is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech...
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Associate Director, Early Development Lead
vor 3 Wochen
City of Melbourne, Österreich CSL Plasma Inc. VollzeitAssociate Director, Early Development Lead page is loaded## Associate Director, Early Development Leadlocations: APAC, AU, Victoria, Melbourne, CSL Limited Melbournetime type: Vollzeitposted on: Heute ausgeschriebentime left to apply: Enddatum: 4. Dezember 2025 (Noch 13 Tage Zeit für Bewerbung)job requisition id: R- **Your Opportunity:**CSL's R&D...
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Associate Director, Early Development Lead
vor 3 Wochen
City of Melbourne, Österreich CSL Plasma Inc. VollzeitAssociate Director, Early Development Lead page is loaded## Associate Director, Early Development Leadlocations: APAC, AU, Victoria, Melbourne, CSL Limited Melbournetime type: Full timeposted on: Offerta pubblicata oggitime left to apply: Data fine: 4 dicembre 2025 (13 giorni rimanenti per candidarsi)job requisition id: R- **Your Opportunity:**CSL's R&D...
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Associate Director, Early Development Lead
vor 3 Wochen
City of Melbourne, Österreich CSL Plasma Inc. VollzeitAssociate Director, Early Development Lead page is loaded## Associate Director, Early Development Leadlocations: APAC, AU, Victoria, Melbourne, CSL Limited Melbournetime type: Full timeposted on: Posted Todaytime left to apply: End Date: December 4, 2025 (13 days left to apply)job requisition id: R- **Your Opportunity:**CSL's R&D organisation is accelerating...
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Associate Director: Early Development Safety Lead
vor 3 Wochen
City of Melbourne, Österreich CSL Plasma Inc. VollzeitA leading global biotechnology company in Melbourne seeks an Associate Director, Early Development Lead. This role involves overseeing safety surveillance and risk management for clinical assets, requiring a PhD or medical degree and significant experience in the pharmaceutical sector. Ideal candidates will possess expertise in toxicology and pharmacology,...
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Associate Director/Director – Corporate Development M&A
vor 11 Stunden
City of Melbourne, Österreich East Partnership VollzeitAssociate Director/Director – Corporate Development M&A Associate Director/Director – Corporate Development M&A High-growth, entrepreneurial business with global reach Tech-focused Melbourne based role This is a rare chance to join a rapidly growing and acquisitive corporate, operating in the technology sector. You’ll be part of a lean, high-energy,...
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Strategic Leader, Early Development Safety
vor 1 Woche
City of Melbourne, Österreich Csl VollzeitA leading global biotechnology company is looking for an Associate Director, Early Development Lead in Melbourne. The successful candidate will be responsible for designing safety strategies for clinical assets and developing risk mitigation strategies while ensuring compliance with regulations. The ideal candidate will hold a PhD or medical degree and have...
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Senior Safety Lead for Early Development
vor 3 Wochen
City of Melbourne, Österreich CSL Plasma Inc. VollzeitA leading biotechnology company in Melbourne seeks an Associate Director, Early Development Lead to oversee safety strategies for preclinical and early clinical assets. This role involves analyzing safety data, developing risk mitigation plans, and ensuring compliance with regulatory requirements. Candidates should have a PHD or medical degree and...
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Senior Early-Development Safety Lead for Phase 1
vor 3 Wochen
City of Melbourne, Österreich CSL Plasma Inc. VollzeitA leading biotechnology company is seeking an Associate Director, Early Development Lead to design and implement safety surveillance and risk management strategies for early clinical assets. The ideal candidate will have a PhD or medical degree, a minimum of 5 years' experience in the pharmaceutical industry, and strong communication skills. Join a dynamic...
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Centre Director
Vor 2 Tagen
City of Hobart, Österreich Goodstart Early Learning VollzeitA leading early learning organization in Hobart seeks a Centre Director to manage and develop a nurturing environment for educators and children. In this role, you will lead a talented team in delivering a bespoke learning program and maintain a thriving business. The ideal candidate will have experience in early childhood education and leadership, offering...
