Hello all,
An exciting opportunity in a rapidly growing company.
Thanks
Sridhar
Company Overview
Cerevel Therapeutics is a new biopharmaceutical company formed by Bain Capital
and Pfizer that relentlessly finds paths through complexity to bring real
progress and new treatment options to people living with neurological and
neuropsychiatric disorders.
Our portfolio of pre-commercial neuroscience assets targets a broad range of
central nervous system (CNS) disorders including Parkinson’s, Alzheimer’s,
epilepsy, schizophrenia and addiction.
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 respect,
trust, curiosity, 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 his/her 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.
Key Responsibilities
* Responsible for overall Clinical Pharmacology and M&S strategy to
support Cerevel portfolio and other compounds in clinical development.
* Lead all quantitative pharmacology activities to support both
regulatory filings and internal decision-makings (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
* Independently formulate clinical pharmacology strategy to support
regulatory submissions
* Work in close partnership different partner lines to advance programs
from Phase I to late-stage development
* 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. food effect, human ADME, drug interactions, QTc, renal and
hepatic impairment)
* Provide ad-hoc support to other programs as needed
Required Qualifications
* High-level of experience in Clinical Pharmacology with a demonstrated
ability to implement pharmacometric principles in drug development
* Strong understanding of clinical pharmacokinetic concepts
* Hands-on modeling experience (i.e. NONMEM, R and Phoenix WinNonlin)
* Regulatory filing experience
* Working knowledge of DMPK and Toxicology
* Effective verbal and written communication skills are essential for
the role
Preferred Qualifications
* Neuroscience Experience is preferred
Education
* PhD in pharmacokinetics, pharmaceutical sciences, or a related field
with 8+ years of experience
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.
Interested candidate, please apply at :
https://jobs.lever.co/cerevel-2/c997652f-250b-4d5d-b082-b798769541c9
