Associate Director, Clinical Trial Disclosure & Transparency

CSL; Thatcham; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global biotechnology company is seeking an Associate Director Clinical Trial Disclosure in Thatcham. This role focuses on strategic oversight and compliance for clinical trial disclosures, ensuring timely and accurate submissions worldwide. Ideal candidates possess extensive experience in pharma/biotech, expertise in disclosure regulations, and the ability to manage cross-functional teams efficiently. Join a dynamic environment committed to innovation and making a difference in patients' lives.

Benefits

Well-being support

Qualifications

• 10+ years in pharmaceutical/biotech environment with deep knowledge of drug development.
• Hands-on experience using regulatory compliance tools like Trialscope.

Responsibilities

• Lead enterprise clinical trial disclosure strategy.
• Oversee and deliver compliant disclosures and redacted document packages.
• Track and report key metrics for compliance.
• Partner with cross-functional teams to ensure alignment.

Skills

Expert in global clinical trial disclosure and transparency regulations

Experience with vendor oversight

Strong understanding of ICH-GCP and GDPR

Proven track record in cross-functional teamwork

Education

Bachelor’s degree in a scientific, medical, or pharmaceutical discipline

Tools

Trialscope Disclose system

Job description

CSL's R&D organization 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 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, results,andlayperson summaries,anonymization 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,clinicaltrials.gov, CTIS,EU CTR 536 / 2014,EMA 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., ClinicalTrials.gov, 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, Regulatory,IP, Legal,Data Privacyand CMO staff to embed disclosureand transparencyrequirements across the development lifecycle

Represent CSL’s 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 transparencyregulations,andguidelines and registries

Proven track record in managing global disclosureand transparencydeliverables and working in cross-functional, matrixed teams

Strong understanding of ICH-GCP, ICMJE,GDPRand 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

Bachelor’s degree in a scientific, medical, or pharmaceutical discipline required

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.