Associate Director, Early Development Lead
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Your Opportunity:
CSLs R&D organisation is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were 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 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.
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 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.
Your Experience:
- PHD degree or medical degree ( Doctors) 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.
Desirable Skills:
- 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.
Our Benefits
We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.
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. Since our start in 1916 we have been driven by our promise to save lives through innovation. Learn more about CSL.
We want CSL to reflect the world around us
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. Learn more Inclusion and Belonging CSL
Do work that matters at CSL!
Required Experience:
Director
Key Skills
- Fundraising
- Management Experience
- Biotechnology
- Clinical Development
- Clinical Trials
- Research & Development
- Training & Development
- Grant Writing
- Economic Development
- Leadership Experience
- Public Speaking
- Product Development
About Company
Join the thousands of people who safely donate plasma each week at CSL Plasma and get rewarded for your time.
