Associate Director/Director, Clinical Pharmacology
Location
Gaithersburg, MD | United States
Job description
Company Description
I-Mab (Nasdaq: IMAB) is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal discovery and global partnerships for in-licensing, based on the Company's Fast-to-Proof-of-Concept and Fast-to-Market development strategies. The Company is progressing from a clinical stage biotech company into a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit and follow I-Mab on LinkedIn, Twitter and WeChat.
Job Description The Clinical Pharmacologist will focus on dose selection and optimization. This job position requires strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles for effective drug development. You are accountable for PK/PD strategy, implication and interpretation to other strategic business units, internal and external stakeholders and provide quality services
Analyze clinical PK/PD data as a member of several multidisciplinary development program teams
- Work with clinical teams to design PK/PD components in various study designs such as first-in-human, bioequivalence and drug-drug interaction studies etc.
- Contribute to clinical PK/PD sections of relevant documents
- Contribute to the design, analysis, reporting, and presentation of PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of development
- Review scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports
- Maintain a working knowledge of pharmacology, statistics, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics
- Develop and maintain a relationship with internal and external stakeholders and scientists
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
- Reviewing/Authoring scientific publications, abstracts, posters
- Participate in Business Development activities, compounds evaluation projects etc.
Qualifications - An advanced science degree (MS, PharmD, PhD, MD) and/or relevant experience
- Strong knowledge of PK and PD principles
- Experience with the design and implementation of Model-Based Drug Development strategies
- Knowledge of Pharmacometrics methodologies
- Experience in Pharmacokinetic modeling Software such as MONOLIX, Phoenix WinNonlin
- Experience in other software such as NONMEM, GastroPlus and R is desirable
- Excellent interpersonal, verbal and written communication skills
- Strong clinical/scientific writing skills
- Client focused approach to work
- Exhibit and promote a flexible attitude with respect to work assignments and new learning
- The ability to manage multiple and varied tasks with enthusiasm
- The willingness to work in a matrix environment and to value and promote the importance of teamwork
- A minimum of 5 years of experience in drug development
- Strong written and spoken English communication skills
Additional Information All your information will be kept confidential according to EEO guidelines.
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