Full-Time

Senior Manager

Cerevel Therapeutics

Cerevel Therapeutics

201-500 employees

Develops therapies for central nervous system disorders

Biotechnology

Senior

Remote in USA

Required Skills
Communications
Requirements
  • Experience supporting small molecule programs
  • Effective verbal and written communication skills
  • Hands-on experience in performing population PK and PKPD modelling using NONMEM/R or similar software is preferred
Responsibilities
  • Responsible for planning and executing state-of-art Clinical Pharmacology program and M&S strategy to support Cerevel portfolio including Go/No-go decision making and dose finding strategies
  • Oversee the design and protocol writing of clinical pharmacology studies (e.g., food effect, human ADME, drug-drug interactions, QTc, and hepatic/renal impairment)
  • Lead or Co-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 to advance programs from Phase I to late-stage development
  • Independently formulate clinical pharmacology strategy to support regulatory submissions
  • Establishing tools and methods which create opportunities for novel solutions
  • Anticipates potential multi-discipline problems and proposes innovative mitigation strategies
  • Manage external contract research organizations
  • Draft clinical pharmacology components of protocols, INDs, investigator's brochure and other regulatory documents
  • Provide ad-hoc support to other programs as needed

Cerevel Therapeutics stands out as a leading biopharmaceutical company with a concentrated focus on developing therapies for central nervous system disorders, a field that impacts hundreds of millions globally. Their competitive edge lies in their robust portfolio of experimental neuroscience therapies, including three clinical-stage compounds and several pre-clinical compounds, targeting a wide range of disorders such as Parkinson’s, Alzheimer’s, and epilepsy. The company's culture is driven by a commitment to understanding neurocircuitry deficits, which fuels their research and development efforts towards addressing these underserved areas and communities.

Company Stage

N/A

Total Funding

$1.8B

Headquarters

Cambridge, Massachusetts

Founded

2018

Growth & Insights
Headcount

6 month growth

7%

1 year growth

16%

2 year growth

58%