The Global Lead, Clinical Trial Disclosure and Transparency is a key leadership position responsible for providing strategic leadership, development, and management of CSLs global Clinical Trial Disclosure and Transparency function. The incumbent will lead and develop the group responsible for clinical trials registration, summary results disclosure, data disclosure and transparency responsibilities in all regions across the global CSL organization according to CSL policy.
He/she is responsible for guiding innovative development, oversight and management of flexible and scalable processes to support current and future global clinical trial disclosure requirements, including global clinical trial registration and results disclosure, voluntary clinical data sharing, layperson summaries and other transparency related activities.
1) Oversees and drives the Clinical Trial Disclosure and Transparency group, accountable for the operational execution of deliverables, including:
- Strategically aligned and timely clinical trial registration and disclosure activities compliant with applicable global regulations
- Redacted data packages for regulatory agency submissions and for approved voluntary sharing with external researchers
- In collaboration with Clinical Development Teams, provision of patient thank-you notes and ?patient-centric layperson (plain language) summaries of clinical trials in-line with best practices and global regulatory requirements.
Understands impact of operational issues, identify actions required and take action. Following problem solving activities escalate any unresolved issues to Director, Office of the CMO in a timely manner.
2) Leads CSLs strategic Clinical Trial Disclosure and Transparency activities, including:
- Internally communicates CSLs Clinical Trial Disclosure and Transparency strategy
- Maintains awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translates into CSLs Clinical Trial Disclosure and Transparency strategy.
- Based on impact to CSL, identifies and leads initiatives focused on compliance with new and upcoming Clinical Trial Disclosure and Transparency regulations and requirements globally
Provides guidance on CSLs Clinical Trial Transparency and Data Sharing policy, issue resolution and escalation as necessary to Clinical Disclosure and Transparency Steering Committee.
3) Subject Matter Expert (SME) and advisor on CSLs approach to clinical trial disclosure and transparency globally
- Provides high level of integrated expertise and technical guidance across clinical trial disclosure, transparency and data sharing activities to staff, project teams and senior management on an ongoing basis
- Provides oversight of SOPs and guidance documents owned by Clinical Trial Transparency and Disclosure
Educates the organization and enables a culture of disclosure and transparency
4) Accountable for high quality, efficient and effective CSL clinical trial disclosure and transparency processes and systems
- Develops a sustainable, end-to-end process to fulfill CSLs commitment to responsible and ethical approach to trial disclosure and transparency across the organization
- Accountable for global disclosure and transparency procedural documents and standards that minimize company risk
- Oversees the collection of meaningful metrics, monitors metrics over time and develops action plans for continuous improvement. Communicates findings appropriately.
Oversight of clinical trial disclosure system to ensure compliance with regulations globally.
5) Manage the Clinical Trial Disclosure and Transparency function ensuring appropriate and timely support for all clinical programs, and for Medical Affairs and Commercial teams. Tasks include:
- Allocation and monitoring of internal and external resources
- Budget setting, monitoring against spend and regular forecasting
- Provides input to selection, and approval of disclosure and transparency vendors
Management of staff including development by coaching, mentoring and providing training
6) Responsible for the quality of Clinical Trial Disclosure and Transparency activities:
- Oversees harmonization activities across clinical trial registries and publically disclosed information.
- Acts as primary point of contact for all training needs, internal audits and external inspections
- Develops global training strategy for functional owned processes.
Leverages synergies with other functions and/or systems to ensure alignment of processes resulting in high quality and efficient deliverables.
Bachelors degree in a scientific/medical/pharmaceutical discipline is required, preferably combined with relevant post-graduate qualifications. Other commensurate qualifications and/or related experience in industry considered if equivalent.
At least 10 years working in a Clinical Development and/or regulatory affairs environment is required, with a minimum of five years of work experience in clinical trial disclosure and transparency.
Proven global experience in a global biotechnology or pharmaceutical environment. Line manager experience advantageous.
Solid understanding of the overall drug development pathway, including early development, safety and pharmacovigilance, clinical development, regulatory affairs, medical affairs.
Demonstrated experience leading and participating in global, cross-functional teams in a matrix environment. Has in-depth knowledge and expertise in project management.
Recognized expert in international regulatory guidelines pertaining to clinical trial disclosure, transparency and data sharing. Demonstrated ability to keep up to date and anticipate future impact to the organization.