Job Title: Senior Manager, Clinical Pharmacology & DMPK Department: Clinical Pharmacology & DMPK 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 performing 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 #J-18808-Ljbffr Summittherapeutics
Overview: Performs maintenance and repair activities on gas compression and/or process equipment, at customer's location, as directed. Acts as a technical resource for more complex issues in assigned area. Skills and Abilities: Ability to: - Demonstrate advanced...
...forward. Collaborate with internal and external partners and research projects to produce effective solutions for maintaining cost,... ...in Program Management or senior-level experience in pharmaceutical/biotechnology vaccine and drug development portfolio management...
Native speaker of any kind of languages as below:.American English.British English.Russian.Germany.French.Japanese.Korean.Arabic.Turkishand so on.
...Job Description Job Description Job Title: Reading Specialist Organization: Phillips Brooks School (PBS) About Phillips Brooks School: PBS is a vibrant and innovative ELC to 5th grade school committed to fostering a love of learning in a supportive and inclusive...
...contribute to our inclusive work environment. Tankerman are responsible for safely and efficiently transferring various types of barges, troubleshooting barges, performing minor maintenance of barges and training other Tankerman to do so in accordance with all...