Cerevel Therapeutics is hiring a
Senior Manager Clinical Trial Transparency and Disclosure, Remote - United States

Summary

The Senior Manager of Clinical Trials Transparency and Disclosure at Cerevel is responsible for leading global clinical trial disclosure activities in accordance with applicable laws, regulations, and policies. The role requires a minimum of 6 years of experience in the biotech or pharma industry, including 4 years in transparency and disclosure, and an academic degree in a relevant scientific or healthcare discipline.

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 (layperson) summaries, results postings, and redactions and understanding of Good Lay Summary Practice (CTEG working Group)
• Expertise with postings on clinicaltrials.gov and with EU CTR 536/2014 regulations
• Deep understanding of US and EU requirements for global transparency and clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)
• Experience working with CTIS preferred
• Understands the clinical drug development process, including clinical trial design, operations and results analysis
• Strong leadership, planning, and project management skills, along with initiative and ability to be productive independently and with minimal administrative support
• Ability to evaluate and recommend process improvement and suggest/implement best practices
• Outstanding oral and written communication skills
• Strong analytical and problem-solving skills; ability to organize/track complex information & prioritize
• Flexible; adapts work style to meet organization needs
• Proficient with Microsoft Office products such as (Outlook, Word, Excel, PowerPoint, SharePoint, and Teams), Smart Sheet, Please Review, Veeva Vault, and Adobe Suite

Responsibilities

• Lead Global Clinical Trials Transparency Workstream and provide vendor oversight
• If needed, lead the development of Cerevel’s overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary
• Manage the preparation of plain language (layperson) summaries and redaction of clinical documents in accordance with EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulations
• 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 & postings (e.g., plain language [layperson] summaries, interim and/or final results postings, and redaction documents); acting 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 across countries, websites, databases, and documents
• 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 such as clinical trial protocols and Clinical Study Reports to minimize CCI and PPD
• Act as a subject matter expert during regulatory inspections

Preferred Qualifications

• Recent neuroscience experience (within 2 years)
• Experience contributing to outsourcing strategies and vendor selection, including resourcing/budgeting forecasts for assigned projects
• Prior experience working in Clinical Development, Clinical Operations, or Medical Writing

Benefits

Education: Academic degree (BA/BS at minimum) in a relevant scientific or healthcare discipline, advanced degree (eg PhD) in scientific or healthcare field preferred