Senior Scientist, Clinical Pharmacology
Abata TherapeuticsSalary not specified
Full Time
Senior (5 to 8 years)
[Remote] Associate Director, Clinical Pharmacology and Pharmacometrics at Axsome Therapeutics Inc
Remote
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, ImmunologyIndustries
Requirements
- PhD with 5+ years relevant industry experience (clinical pharmacology, quantitative pharmacology, clinical PK/PD)
- Ability to analyze and interpret PK, PK/PD and pharmacometrics data utilizing sound scientific principles
- Experience with the use of software packages such as Phoenix, R, NONMEM for PK, PK/PD and pharmacometrics data analysis and modeling and simulation
- Strength in delivering results on agreed timelines to advance Vera’s pipeline
- Excellent oral and written communication skills and ability to effectively collaborate with cross-functional teams and contribute to decisions
- Experience working in a matrix environment
- Experience managing collaborations with contract research organizations (CROs), consultants, pharmaceutical partners and other outside organizations
- Ability to think critically and solve problems, possess a quick and analytical mind, a fast-learner who works well in an organization that highly values intellectual capacity and scientific contributions
Responsibilities
- Provide clinical pharmacology and pharmacometrics expertise to program and study teams throughout the drug development lifecycle
- Develop & implement clinical pharmacology and pharmacometrics plans, considering all aspects (strategic, scientific, translational, and clinical)
- Analyze and interpret results from clinical pharmacology and pharmacometrics data analysis, and recommend appropriate actions based on results
- Serve as lead author and key contributor for clinical pharmacology sections of clinical and regulatory documents
- Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes
- Collaborate with Biostats, Data Management, Clinical Operations & Medical to support development projects
Skills
Clinical Pharmacology
Pharmacometrics
PK/PD Modeling
Drug Development
IND
Phase IV
Cross-Functional Teams
BAFF/APRIL Inhibitors
Axsome Therapeutics Inc
Develops therapies for CNS disorders
About Axsome Therapeutics Inc
Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.
New York City, New YorkHeadquarters
2012Year Founded
$430.7MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees