Associate Director, Clinical Trial Disclosure & Transparency

CSL Plasma; Maidenhead; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biotech company in the UK seeks an experienced Associate Director for Clinical Trial Disclosure and Transparency. This role entails managing compliance with global regulations, supporting clinical teams, and enhancing operational efficiency. Ideal candidates will have over 10 years in the pharma/biotech field and expertise in clinical trial disclosures. The position offers opportunities to work collaboratively across teams and contribute to meaningful healthcare outcomes.

Benefits

Comprehensive health benefits

Well-being programs

Qualifications

• 10+ years in pharmaceutical/biotech environment.
• Proven track record in managing global disclosure and transparency deliverables.
• Experience with cross-functional teams.

Responsibilities

• Lead clinical trial disclosure strategy and advise teams.
• Oversee compliant disclosures including study registration and results.
• Partner with multiple departments to ensure alignment with standards.

Skills

Knowledge of drug development process

Expertise in clinical trial disclosure regulations

Vendor management experience

Process improvement skills

Strong understanding of ICH-GCP and GDPR

Hands-on experience with inTrialscope Disclose

Education

Bachelor’s degree in scientific or medical discipline

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 seeking an Associate Director Clinical Trial Disclosure and Transparency who 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, lay‑person summaries, anonymization and redaction of commercially confidential information (CCI) for clinical trials, in alignment with international regulations, CSL policy, industry standards and transparency requirements.

Key Responsibilities

Strategic Oversight & Compliance

• Lead enterprise clinical trial disclosure and transparency strategy and advise therapeutic areas and Medical Affairs on global requirements (e.g., FDAAA 801 and 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 Privacy and CMO staff to embed disclosure and transparency requirements across the development lifecycle.
• Represent CSL’s disclosure and transparency practices internally and externally, ensuring alignment with global standards and expectations.

Vendor Management

• Select, manage, and oversee disclosure and transparency vendors 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 disclosure and transparency regulations, guidelines and registries.
• Proven track record in managing global disclosure and transparency deliverables and working in cross‑functional, matrixed teams.
• Strong understanding of ICH‑GCP, ICMJE, GDPR and industry best practices.
• Experience with vendor oversight, process improvement, and innovation in disclosure and transparency operations.
• Hands‑on experience with the use and administration of the inTrialscope 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. Learn more about how we care at CSL.

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.

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 at CSL.

Do work that matters at CSL Behring!