Associate Director, Early Development Lead, Medical Safety at CSL

Melbourne Airport, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

13 Apr, 26

Salary

0.0

Posted On

13 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Risk Management, Safety Surveillance, Data Analysis, Pharmacology, Toxicology, Communication, Leadership, Conflict Management, Adaptability, Regulatory Compliance, Clinical Trials, Safety Reviews, Cross-Functional Collaboration, Empirical Evidence, Patient Safety, Risk Mitigation

Industry

Pharmaceutical Manufacturing

Description

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 ecosystems. 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 , Medical Safety who is a strategic safety leader responsible for the integrated interpretation of the totality of preclinical safety data, leveraging deep scientific expertise and empirical evidence from diverse sources to assess and quantify uncertainty and potential patient safety risks. Translates complex safety insights into the design and execution of robust safety surveillance frameworks and proactive risk management and mitigation strategies for preclinical assets in advance of first-in-human studies. Serves as the safety representative on research and early development teams, ensuring cross-functional and key stakeholders alignment on acceptability and expectedness of potential safety risks when weighed against unmet medical needs and therapeutic benefits, and risk mitigation strategies to be implemented. Reporting to the Senior Director, TA Head Vaccines & Head of Medical Safety Early Development Your Role: 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 and concisely 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 as needed. Your Experience: PHD degree, or medical degree (Doctors) with exposure to basic research work Minimum 5 years in pharmaceutical/biotechnology industry, preferably in a safety (MD) or research role (PhD) At least 3 years working with early clinical development assets leading to FIH or Phase 1-2 studies Subject matter knowledge in non-clinical toxicology, pharmacology, and manufacturing aspects relevant to safety Ability to develop a risk management framework through identification of potential risks, likelihood/uncertainty, and impact assessment Ability to perform qualitative therapeutic benefit-risk assessments with guidance Strong communication skills with the ability to synthesize complex concepts, seek feedback, and tailor messages for effective communication Exhibit leadership skills like independent thinking, cross-functional influence, conflict management, and adaptability to diverse situations and cultures. Desirable Skills: Knowledge in safety signal identification, evaluation, escalation, and risk mitigation Knowledge of PV systems, familiarity with global regulatory guidelines pertaining to non-clinical safety and clinical safety Location: Melbourne CBD, also consider Zurich, Switzerland Hybrid Working. Closing date for Application Friday 30th January 2026 About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here. CSL Global Privacy Notice for Job Applicants and Candidates

Responsibilities

Develop and implement risk mitigation strategies for early development assets, ensuring alignment with CSL Safety Governance. Serve as the safety representative on research and early development teams, translating safety insights into actionable strategies.