Senior Manager Clinical Pharmacology DMPK
Senior Manager Clinical Pharmacology DMPK
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$ 165000 - 180000
1 Vacancy
Job Description
Overview of Role:
The Senior Manager Clinical Pharmacology & DMPK will manage clinical pharmacology pharmacokinetic (PK) drug metabolism (DM) and bioanalytical (BA) supports and operation for Summits assets. This role is responsible for PK and ADA samples management vendor management and perform data analysis to support projects.
Role and Responsibilities:
- Serve as Clinical Pharmacology and DMPK subject matter expert on crossfunctional teams in both early and latestage projects
- Design and outsource in vitro and in vivo ADME studies to characterize the compounds
- Manage external vendors for bioanalysis including validation and sample analysis
- Oversee the collection processing storage tracking distribution and reconciliation of PK/ADA samples
- Ensure data integrity and compliance with Good Clinical Practice (GCP) regulations throughout the drug development process
- Collaborate with cross functional teams and central laboratories to manage sample logistics and chainofcustody procedures
- Perform NCA data analysis/interpretation and reporting
- All other duties as assigned
Experience Education and Specialized Knowledge and Skills:
- Ph.D. Pharm.D. or equivalent training in pharmacokinetics pharmaceutical sciences or related disciplines with 1 years of clinical pharmacology industry experience or M.S. with 5 years of relevant experience
- Experience in clinical trial design and preferably in various phase clinical studies
- Understanding of clinical pharmacology concepts and conducting clinical pharmacology studies and knowledge of regulatory requirements related to clinical trials (GCP ICH guidelines) and drug development
- Handson experience with standard PK Software (e.g. Phoenix WinNonlin).
- Strong project management skills and ability to prioritize and manage multiple projects simultaneously
- Excellent communication organizational and problemsolving skills
The pay range for this role is $165000$180000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Senior Manager
Employment Type
Full-Time
