Company Overview
Cerevel Therapeutics is dedicated to uncovering the mysteries of the brain in order to treat neurological diseases. We address neuroscience conditions using a differentiated approach that combines deep expertise in neurocircuitry with a strong emphasis on receptor selectivity. Our pre-commercial neuroscience pipeline targets a wide range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease, and substance use disorder.

Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to develop breakthrough CNS therapies that make a real difference in people’s lives.

Cerevel aims to build and sustain a culture defined by trust, respect, courage, curiosity, and compassion, with an unwavering focus on our mission and results. We place patients at the center of everything we do—guiding our purpose, how we interact with one another, and how we spend our days. The ideal candidate will bring their own unique perspective and approach while aligning with Cerevel’s core values and convictions.

Role Summary:
The Director of Clinical Trials Transparency and Disclosure leads and manages Global Clinical Trial Disclosure and Data Transparency activities in accordance with applicable laws, regulations, and company policies. This role serves as a subject matter expert and the primary point of contact for Cerevel’s transparency and disclosure efforts, including posting clinical trial results, managing document redactions, and creating layperson results summaries. The Director will collaborate with senior leadership and teams across relevant functions and will manage employees and/or vendors directly involved in disclosure and transparency activities. The successful candidate must be flexible, detail-oriented, self-directed, and able to manage workload to meet submission deadlines across all company programs.

Key Responsibilities
– Lead the Global Clinical Trials Transparency workstream and provide vendor oversight; may build and manage a Clinical Trial Transparency and Disclosure team
– Define Cerevel’s global clinical trials transparency and disclosure strategy, goals, and objectives
– Lead development of Cerevel’s global clinical trials transparency and disclosure policy with key stakeholders and update it as needed
– Manage preparation of plain-language (layperson) summaries and redaction of clinical documents in line with EMA Policy 0070, the EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other applicable global requirements
– Educate and increase company-wide awareness of transparency and disclosure regulations and industry trends
– Coordinate cross-functional teams to deliver high-quality, scientifically accurate documents and postings (e.g., lay summaries, interim and/or final results postings, and redaction materials), acting as the liaison between the vendor and Cerevel teams
– Manage multiple projects across programs, coordinating work plans with corporate timelines and strategic priorities
– Lead teams in developing and maintaining CCI and PPD rules across programs to ensure consistent publicly disclosed information across countries, websites, databases, and documents
– Lead initiatives such as trainings and workshops and develop, update, and maintain SOPs, work instructions, and user guides as needed
– Promote efficient writing practices for regulatory documents such as clinical trial protocols, Investigator’s Brochures, and Clinical Study Reports to minimize CCI and PPD
– Serve as a subject matter expert during regulatory inspections

Required Qualifications
– Minimum of 8 years of experience in the biotech or pharmaceutical industry, including at least 5 years specifically in transparency and disclosure; an advanced degree, academic research, or other transferable experience may be considered in place of part of the industry experience
– Experience writing plain-language (layperson) summaries, results postings, and redactions, with an understanding of Good Lay Summary Practice (CTEG Working Group)
– Expertise with postings on https://clinicaltrials.gov and knowledge of EU CTR 536/2014
– Strong understanding of U.S. and EU requirements for global transparency and clinical trial disclosure, as well as related policies (e.g., ICMJE, and PhRMA/EFPIA principles for responsible data sharing)
– Experience working with CTIS is preferred
– Understanding of clinical drug development, including clinical trial design, operations, and results analysis
– Strong leadership, planning, and project management skills, with the initiative and ability to work independently with minimal administrative support
– Ability to evaluate processes, recommend improvements, and identify or implement best practices
– Excellent written and verbal communication skills
– Strong analytical and problem-solving abilities, including the capacity to organize and track complex information and prioritize effectively
– Adaptable and able to adjust work style to meet organizational needs
– Proficiency with Microsoft Office tools (Outlook, Word, Excel, PowerPoint, SharePoint, Teams), and tools such as Smartsheet, “Please Review,” Veeva Vault, and the Adobe Suite

Desired Qualifications
– Recent neuroscience experience (within the past 2 years)
– Experience supporting outsourcing strategies and vendor selection, including resourcing and budget forecasting for assigned projects
– Prior experience in Clinical Development, Clinical Operations, or Medical Writing
– 2+ years of experience managing direct reports

Education
– Bachelor’s degree (BA/BS minimum) in a relevant scientific or healthcare discipline; advanced degree (e.g., PhD) in a scientific or healthcare field preferred

Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying disability (physical or mental), national origin, veteran status, or any other protected characteristic under applicable law.

Compensation
$50,000 — $85,000 per year