About the position
The Senior Manager of Clinical Trials Transparency and Disclosure is a pivotal role within Cerevel, responsible for leading and managing the Global Clinical Trial Disclosure and Data Transparency activities in compliance with applicable laws, regulations, and internal policies. This position serves as the subject matter expert and primary point of contact for all transparency and disclosure activities, including clinical trial results postings, document redactions, and layperson results summaries. The Senior Manager will collaborate closely with senior management and team members across various functional areas, ensuring that all disclosure activities are executed efficiently and effectively. Additionally, this role involves managing vendors who are directly engaged in activities related to disclosure and transparency, ensuring that all external partnerships align with Cerevel's standards and expectations. In this role, the successful candidate must demonstrate flexibility, attention to detail, and the ability to self-direct their workload to meet submission timelines across all company programs. The Senior Manager will lead the Global Clinical Trials Transparency Workstream, providing oversight to vendors and ensuring that all activities are conducted in accordance with regulatory requirements. This includes leading the development and ongoing updates of Cerevel's global clinical trials transparency and disclosures policy in collaboration with key stakeholders. The Senior Manager will also be responsible for managing the preparation of plain language summaries and the redaction of clinical documents, adhering to regulations such as EMA Policy 0070, EU Clinical Trial Regulation, and Health Canada Public Release of Clinical Information (PRCI). Furthermore, the Senior Manager will play a crucial role in educating the organization about transparency and disclosure regulations, coordinating cross-functional teams to produce high-quality, scientifically accurate documents and postings. This includes acting as a liaison between vendors and Cerevel teams, ensuring that all outputs meet corporate timelines and strategic objectives. The role also involves leading initiatives such as training sessions and workshops, developing and updating standard operating procedures (SOPs), work instructions, and user guides as necessary. The Senior Manager will advise on lean writing practices for regulatory documents to minimize confidential commercial information (CCI) and protected personal data (PPD), and will act as a subject matter expert during regulatory inspections.
Responsibilities
- Lead Global Clinical Trials Transparency Workstream and provide vendor oversight.
- Develop Cerevel's overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary.
- Manage the preparation of plain language summaries and redaction of clinical documents in accordance with EMA Policy 0070, EU Clinical Trial Regulation, and Health Canada PRCI.
- Educate and provide company-wide awareness of transparency/disclosure regulations and industry trends.
- Coordinate efforts of cross-functional teams to produce high-quality, scientifically accurate documents and postings.
- Act as liaison between the vendor and Cerevel teams.
- Work on multiple projects across programs, coordinating work plans that align with corporate timelines and strategic plans.
- Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information.
- Lead initiatives including trainings and workshops, and develop/update SOPs, work instructions, and user guides as needed.
- Advise on lean writing practices for regulatory documents to minimize CCI and PPD.
- Act as a subject matter expert during regulatory inspections.
Requirements
- Minimum of 6 years experience in the biotech or pharma industry; including a minimum of 4 years in transparency and disclosure.
- Experience writing or managing plain language summaries, results postings, and redactions with an understanding of Good Lay Summary Practice.
- Expertise with postings on clinicaltrials.gov and EU CTR 536/2014 regulations.
- Deep understanding of US and EU requirements for global transparency and clinical trial disclosure.
- Experience working with CTIS preferred.
- Understanding of the clinical drug development process, including clinical trial design, operations, and results analysis.
- Strong leadership, planning, and project management skills, with the ability to work independently.
- Ability to evaluate and recommend process improvements and implement best practices.
- Outstanding oral and written communication skills.
- Strong analytical and problem-solving skills; ability to organize and prioritize complex information.
- Proficient with Microsoft Office products and other relevant software.
Nice-to-haves
- Recent neuroscience experience (within 2 years).
- Experience contributing to outsourcing strategies and vendor selection, including budgeting forecasts for projects.
- Prior experience working in Clinical Development, Clinical Operations, or Medical Writing.
