Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinsonâs 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 unlock breakthrough CNS therapies that have real impact on peopleâs lives.
Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results. Our patient-centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
The Director of Clinical Trials Transparency and Disclosure is responsible for leading and managing Global Clinical Trial Disclosure and Data Transparency activities per applicable laws, regulations, and policies. This role will serve as a subject matter expert and primary point of contact for Cerevelâs transparency and disclosure activities (eg, clinical trial results postings, document redactions, and layperson results summaries). The Director will partner with and lead interactions with senior management and team members in relevant functional areas and manage staff and/or vendors who are directly involved in activities related to disclosure and transparency. The successful candidate must be flexible, detailed oriented, self-directed and manage workload to meet submission timelines across all company programs.
- Lead Global Clinical Trials Transparency Workstream and provide vendor oversight; potentially build and manage a Clinical Trial Transparency and Disclosure team
- Establish strategic plans and objectives for Cerevelâs global clinical trials transparency and disclosure capabilities
- Lead the development of Cerevelâs 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 (eg, 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
- Ensure lean writing practices for regulatory documents such as clinical trial protocols, Investigatorâs Brochures, and Clinical Study Reports to minimize CCI and PPD
- Act as a subject matter expert during regulatory inspections
- Minimum of 8 years experience in the biotech or pharma industry; including a minimum of 5 years in transparency and disclosure. Advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience.
- Experience writing 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
- 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
- 2+ yearsâ managing direct reports
- Academic degree (BA/BS at minimum) in a relevant scientific or healthcare discipline, advanced degree (eg PhD) in 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 physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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