Principal Investigator, Discovery Project Toxicology (Investigative)
Boston, MA (Remote)
Research and Technical Operations – Safety Assessment & Research Operations /
Full Time /
Remote
Company Overview
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, 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 unlock breakthrough CNS therapies that have real impact on people’s 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.
Role Summary
Reporting to the Senior Director, Head of Toxicology, Safety Assessment, we are seeking a highly experienced Principal Investigator to lead Discovery/IND/Post-IND stage small molecule drug discovery programs, serving as the nonclinical Safety Assessment lead for multiple programs. Additionally, you will provide subject matter expertise in some of the areas of toxicology that include fit-for-purpose safety biomarker development and validation, bio-fluid/tissue biomarker analysis, in silico, genetic, endocrine, and reproductive toxicology efforts to support on-going development of preclinical candidates. The candidate will build the nonclinical package in support of the planned clinical trials and author documents for the upcoming IND/NDA submissions.
The candidate is also expected to support outsourcing efforts for designing, monitoring, execution and reporting of the nonclinical toxicology studies, have experience in managing regulatory-compliant toxicology studies in a CRO or biotechnology/pharmaceutical company, and have demonstrated understanding of GLP compliance and the relevant ICH & FDA guidance documents. The candidate will be also familiar with regulated formulation and bioanalysis for small molecule drugs in nonclinical toxicology studies in rodent and non-rodent species.
Subject matter expertise in a specific area of non-clinical safety, previous experience as a project toxicologist, experience in supporting/authoring the nonclinical sections of regulatory documents will be some of the important attributes for this role. The candidate is expected to work well with colleagues from diverse backgrounds and skill sets and ensure that all projects are completed on time and within budget. The candidate will foster a culture of collaboration, innovation, and excellence to ensure that the team is working together effectively to achieve the organization's strategic goals.
Key Responsibilities
- Project toxicology:
- Provide guidance on safety assessments along with conducting external due diligence activities to support the Discovery and Development project teams and serve as a key resource for toxicology, providing scientific knowledge and expertise to cross-functional project teams
- Competent in integrating nonclinical data from multiple disciplines and crafting the appropriate narratives for internal governance reviews and/or regulatory documentation (IB/IND/NDA)
- Monitor toxicology studies for appropriate conduct, accuracy and timely execution; audit raw data for accuracy, review draft reports and finalize them as submission-ready documents for regulatory authorities. Some domestic and international travel to monitor studies at contract research organizations will be expected for assigned projects
- Proactively attain knowledge of the target, awareness of the competition and relevant global regulatory guidelines specific to the project
- Prepare verbal and written summaries for internal discussions. Work with the Toxicology team to develop optimal strategies to address specific safety issues and partner with project teams
- Issues management – work with internal colleagues and drug safety experts as appropriate, to develop de-risking strategies and resolve identified issues from non-clinical and clinical studies
- Prepare scientific publications and presentations from toxicology and safety pharmacology studies as appropriate.
- Serve as the Subject Matter Expert (SME) for the department:
- Serve as the SME for important toxicology/Safety topics in areas such as safety biomarker analysis, genetic, endocrine, reproductive toxicology, applications of scientific methods to delineate appropriate mode-of-actions on emerging safety issues and the assessment of human relevance of the nonclinical findings in support of the planned and ongoing clinical trials.
Desired Qualifications
- PhD w/ 15+ years related experience, may include post-doctoral experience, Or BS w/ 18+ years working experience
- Demonstrated experience in serving as the project toxicologist in the pharmaceutical drug development setting
- Demonstrated understanding of GLP compliance in conduct of non-clinical toxicology studies
- Proficient in identifying bottlenecks and issues in conduct of studies and timely delivery of data/reports, and highly effective in leveraging cross functional SMEs to find overcome hurdles
- Experience as a subject matter expert in an area of non-clinical safety, experience with regulatory submissions and responses, experience in review of nonclinical safety data to governance committees/management and experience in investigative studies to de-risk liabilities will be considered an added plus
- Experience with small molecule neuroscience drug development
Education
- B.S. with 18+ years of relevant experience (may include years of post-undergraduate academic experience) or Ph.D. with 15+ years of relevant experience (may include years of postdoctoral experience) in Toxicology, Pathology, Physiology, Biochemistry, or expertise in any related biological science disciplines
- Board Certification in Toxicology (DABT) is not required but willingness to achieve DABT certification would be considered a plus
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.
