Director Clinical Trials Transparency and Disclosure

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Company Overview

Cerevel Therapeutics, a neuroscience-dedicated company based in the Greater Boston area, is on a mission to solve the complexities of the brain and develop treatments for central nervous system (CNS) disorders such as schizophrenia, epilepsy, Parkinson’s disease, and substance use disorder. Combining neurocircuitry knowledge with a focus on receptor selectivity, Cerevel seeks to discover transformative therapies. The company culture is built on trust, respect, courage, curiosity, and compassion, emphasizing patient-centricity in all endeavors.

Role Summary

The Director of Clinical Trials Transparency and Disclosure at Cerevel Therapeutics is a leadership position charged with overseeing the company's disclosure and transparency activities in compliance with global laws and regulations. This role will be accountable for strategizing and managing global clinical trial disclosures, providing education on regulations and industry trends, acting as a liaison for vendor and team coordination, and ensuring the preparation of coherent scientific documents. Responsibilities also include maintaining the consistency of disclosed information across countries and ensuring compliance during regulatory inspections.

Key Responsibilities

• Lead and manage Global Clinical Trials Transparency and Disclosure workstreams and vendor relationships.
• Create strategic plans and policies for global clinical trials transparency and update as necessary.
• Oversee the preparation of layperson summaries and redaction of clinical documents based on global regulations.
• Provide company-wide education on transparency and disclosure regulations.
• Coordinate cross-functional efforts to produce high-quality documents and postings.
• Manage multiple projects, aligning with corporate timelines and strategic plans.
• Lead workforce training initiatives, SOPs formulation, and lean writing practices for regulatory documents.
• Function as a subject matter expert during regulatory inspections.

Required Qualifications

• At least 8 years of industry experience in biotech/pharma with a focus on transparency and disclosure.
• Proficiency in creating easy-to-understand summaries and redacting sensitive information in adherence to global guidelines.
• Deep knowledge of clinical trials.gov postings and EU transparency regulations.
• Strong leadership, project management, communication, and problem-solving skills.
• Adaptability and proficiency in Microsoft Office, Project Management, and related software.

Desired Qualifications

• Recent neuroscience experience and expertise in outsourcing strategies and resource forecasting for projects.
• Background in Clinical Development, Clinical Operations, or Medical Writing.
• Experience in managing a team directly.

Education

Candidates should hold a minimum BA/BS degree in a scientific or healthcare field with a preference for an advanced degree such as a PhD. The position is also open to individuals with a strong academic research background.

Equal Opportunity Statement

Cerevel Therapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace, and prohibits discrimination and harassment of any kind.

This job offer was originally published on RemoteOK