Senior Director, Pharmacometrics
Boston, MA (Remote)
Research and Technical Operations – Clinical Pharmacology /
Fulltime SD /
Hybrid
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
In this highly visible role, this individual will independently and implement model informed drug development (MIDD) activities and help optimize drug development projects in Cerevel’s portfolio. The successful candidate will work closely with clinical pharmacologists and other functions in developing and implementing MIDD strategies. Ideal candidate will be a leader in Pharmacometrics and quantitative clinical pharmacology skills with hands-on experience in the implementation of common software tools (e.g., NONMEM, R) for PK and PK/PD analyses. This individual will own the pharmacometrics strategy across the portfolio and has a successful track record of contributing to regulatory interactions and submissions. Self-motivation, strong strategic thinking, and excellent communication skills (both verbal and writing) are required.
Key Responsibilities
- Responsible for planning and executing MIDD and pharmacometrics strategy to support Cerevel portfolio
- Collaborate across different function to impact overall drug development strategy
- Lead M&S activities across all phases of development to support both regulatory filings and internal decision-makings by working closely across departments (i.e. DMPK, toxicology, biology, clinical, statistics etc,) and external vendors
- Represent Pharmacometrics, by working closely with clinical pharmacology leads on project teams and provide input in all phases of drug development, including designing and implementing dose finding strategies to ensure optimal dose and dosing regimens in clinical trials
- Ensure appropriate planning and execution of data modelling/pharmacometrics activities in support of projects
- Develop Pharmacometrics group and mentor junior colleagues on population analysis methodology
- Contribute Pharmacometric expertise to regulatory strategy
- Manage external vendors (contracting, SOWs etc) to ensure high quality deliverables and adherence to planned timelines/budgets
Required Qualifications
- Ph.D., or equivalent training in pharmacokinetics, Pharmacometrics, PKPD modelling or related disciplines with 12+ years of experience
- Expert level skills and expertise (or ability to manage) in modelling and simulation activities (NCA, population PK/PD modelling, literature meta-analyses, exposure-response analyses etc)
- Late stage development and regulatory filing experience
- Drug development experience in Neuroscience is a plus
- Effective verbal and written communication skills are essential for the role
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.
