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 Summit's 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 cross-functional teams in both early- and late-stage 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 chain-of-custody 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 execution, 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
- Hands-on 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 problem-solving skills
This is the pay for this position
Pay Transparency
$148,000-$174,000 USD
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 Summit's Talent Acquisition team at
[email protected] to obtain prior written authorization before referring any candidates to Summit.
