Associate Director, Clinical Trial Disclosure & Transparency
Share
Job Location:
Maidenhead - UK
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
CSLs R&D organization 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 seking an Associate Director Clinical Trial Disclosure and Transparency is a global subject matter expert responsible for ensuring timely accurate and compliant clinical trial disclosures across all regions and study types (interventional and observational). This role guides global strategy drives process excellence and oversees the delivery of registration resultsandlayperson summariesanonymization and redaction of commercially confidential information (CCI)for clinical trials inalignment with international regulations CSL policy and industry standardsand transparency requirements.
Key Responsibilities
Strategic Oversight & Compliance
Lead enterpriseclinical trialdisclosure andtransparencystrategy and advise therapeutic areas and Medical Affairs on global requirements (e.g. FDAAA 801and the Final Rule CTISEU CTR 536/2014EMA Policy 70 Health Canada PRCI)
Develop and implement scalable efficient processes that meet evolving regulatory and industry standards
Serve as the primary liaison to public registries (e.g. EudraCT EU PAS).
Disclosure Execution
Oversee and deliver high-quality compliant disclosures including study registration protocol amendments summary results and lay-person summaries
Ensure timely communication of disclosure obligations to clinical teams affiliates and stakeholders
Support CROs and local teams with regional disclosure needs
Transparency Execution
Oversee and deliver high-quality compliant redacted document packages for public release by global Health Authorities
Advise on transparency obligations and best practices including promotion of Smart Authoring practices to clinical teams and functions
Cross Functional Engagement
Partner with Clinical Development Biostats Medical Writing RegulatoryIP LegalData Privacyand CMO staff to embed disclosureand transparencyrequirements across the development lifecycle
Represent CSLs disclosureand transparencypractices internally and externally ensuring alignment with global standards and expectations
Vendor Management
Select manage and oversee disclosureand transparencyvendors to ensure high-quality deliverables and on-time execution
Optimize resourcing and technology to support cost-effective delivery
Metrics & Monitoring
Track and report key metrics to demonstrate compliance and process performance
Skills and Experience Required
10 years in pharmaceutical/biotech environment with deep knowledge of the drug development process
Expert in global clinical trial disclosureand transparencyregulationsandguidelines and registries
Proven track record in managing global disclosureand transparencydeliverables and working in cross-functional matrixed teams
Strong understanding of ICH-GCP ICMJEGDPRand industry best practices
Experience with vendor oversight process improvement and innovation indisclosure andtransparency operations andtransparencyexecution
Hands onexperiencewith the use and administrationof theinTrialscope Disclose system(or equivalent)
Qualifications and Education Required
Bachelors degree in a scientific medical or pharmaceutical discipline required
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 Behring
CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.
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 Behring!
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
Join the thousands of people who safely donate plasma each week at CSL Plasma and get rewarded for your time.
