Associate Director, Clinical Trial Disclosure & Transparency

BioSpace; King of Prussia (PA); Hybrid; USD 180,000 - 230,000; Full time

Job summary

CSL Behring seeks an Associate Director, Clinical Trial Disclosure and Transparency, a global subject matter expert ensuring timely, accurate, and compliant disclosures across regions and study types. You will guide strategy, drive process excellence, and oversee registration, results disclosure, and lay summaries while supporting anonymization and redaction as required.

In this role, you will partner with Clinical Development, Regulatory, Legal, and Quality teams, manage CROs and vendors, and

Qualifications

• 10+ years in pharmaceutical/biotech environment.
• Global subject matter expert for trial disclosure activities.
• Interpret emerging regulations and assess business impact.
• Lead through influence in a matrix environment.
• Translate regulatory requirements into clear guidance for stakeholders.
• Experience providing strategic oversight of vendors.

Responsibilities

• Lead enterprise clinical trial disclosure strategy and advise on global requirements.
• Oversee registration, protocol amendments, results and lay summaries.
• Coordinate with CROs, affiliates and local teams on disclosure needs.
• Ensure timely communication of obligations to clinical teams and partners.
• Collaborate with Clinical Development, Biostats, Medical Writing, Regulatory, IP, Legal and Privacy.

Skills

Global regulatory knowledge

Vendor management

Strategy & leadership

Cross-functional collaboration

Stakeholder communication

Education

Bachelor's degree in science

Tools

Trialscope Disclose

Job description

The 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 clinical trial disclosure activities including registration, results disclosureandlayperson summaries while providing support for transparency activities including anonymization and redaction of commercially confidential information (CCI) as required for business continuity and operational needs. All activities and deliverables must be conducted inalignment with international regulations, CSL policies, 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,UK Clinical Trials Regulations 2025 (MHRA), EMA Policy 70, Health Canada PRCI)

Monitor emerging regulatory and industry trends and influence CSL's disclosure and transparency strategy accordingly. 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, CTIS, 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

Support transparency activities, including the preparation and delivery of compliant redacted document packages for public release by global Health Authorities, ensuring appropriate business continuity across the disclosure and transparency function.

Provide input 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

Collaborate closely with other CMO Office team members to ensure effective knowledge sharing, operational continuity and seamless execution of interconnected activities

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

Drive process improvement, innovation and operational excellence indisclosure activities

Optimize resourcing and technology to support cost-effective delivery

Metrics & Monitoring

Track, analyse and report key metrics to demonstrate compliance, identify risks and drive continuous improvement

Education Requirements

• 10+ years in pharmaceutical/biotech environment with deep knowledge of the drug development process
• Strong judgement, initiative and ability to operate independently as the global subject matter expert responsible for clinical trial disclosureactivities
• Demonstrated ability to independently interpret emerging regulations, assess business impact, identify compliance risks and develop practical, business-focused recommendations.
• Proven track record in managing global disclosureand transparencydeliverables. Demonstrated ability to lead through influence in a matrix environment without direct reporting authority
• Excellent written and verbal communication skills, with the ability to translate complex regulatory requirements into clear guidance for stakeholders at all levels.
• Strong influencing skills and ability to communicate confidently with senior stakeholders, study teams and external vendors.
• Ability to constructively challenge stakeholders and vendors, provide evidence-based recommendations and maintain professional credibility in complex discussions
• Strong critical thinking skills, with the ability to make decisions and recommendations in ambiguous situations, escalating appropriately when required.
• Strong understanding of ICH-GCP, ICMJE,GDPRand industry best practices
• Demonstrated experience providing strategic oversight of vendors, critically reviewing recommendations and maintaining accountability for final decisions
• Hands onexperiencewith the use and administrationof theTrialscope Disclose system(or equivalent)

Education Requirement

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

This role requires working in office 3 days per week.

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.