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Director, Clinical Pharmacology

Employer
Cerevel Therapeutics
Location
Cambridge, Massachusetts or Remote
Salary
Commensurates with experience
Closing date
Jan 19, 2022

View more

Position Type
Other
Specialty Area
Pharmacology
Work Setting
Pharmaceutical Industry
Hours
Full-time
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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, impactful role, this person will independently lead clinical pharmacology and modeling and simulation (M&S) activities to support Cerevel’s portfolio. You will have the opportunity to present clinical pharmacology plans, updates, and results to project teams and senior management. The successful candidate will have strong quantitative pharmacology skills with experience in development and implementation of M&S activities towards drug development (PK/PD, exposure-response, model-based meta-analysis etc). Self-motivation, strong scientific reasoning, and communication (both verbal and writing) skills, and the ability to function effectively in a team environment are highly desirable.

Key Responsibilities

  • Responsible for planning and executing state-of-art Clinical Pharmacology program and M&S strategy to support Cerevel portfolio. Independently formulate clinical pharmacology strategy to understand PKPD and facilitate Go/No-go decision making
  • Lead all quantitative pharmacology activities to support both regulatory filings and internal decision-making (e.g. Exposure-Response, QTc prolongation risk assessment, population PK/PD analysis) by working closely with internal colleagues (i.e. DMPK, toxicology, biology, clinical, statistics,) and external vendors
  • Responsible for designing and implementing dose finding strategies to ensure optimal dose and dosing regimens in clinical trials
  • Draft clinical pharmacology components of protocols, investigator's brochure and other regulatory documents
  • Oversee the design and protocol writing of clinical pharmacology studies (e.g. SAD/MAD, food effect, BA/BE, human ADME, drug interactions, TQT study, renal and hepatic impairment etc)
  • Work closely with different partner lines to advance programs from Phase I to late-stage development
  • Provide ad-hoc support to other programs as needed

Required Qualifications

  • Phd with 8+ years of experience in Clinical pharmacology
  • Strong quantitative skills and plan for modelling and simulation activities (NCA, population modelling, literature meta-analyses, exposure-response analyses etc)
  • Effective verbal and written communication skills are essential for the role

Desired Qualifications

  • Previous drug development experience in Neuroscience is a plus

Education

  • Ph.D., or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines

Company COVID-19 Vaccination Policy

  • The Company requires all employees to be vaccinated against COVID-19. In connection with your onboarding process, all new employees will need to provide documentary evidence of vaccination. The Company is an equal opportunity employer and will provide reasonable accommodations to those individuals who are unable to be vaccinated consistent with federal, state and local law
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