Clinical Pharmacologist (Senior Manager – Associate Director, depending on qualification)
• Full-time
• Reporting to Head of Clinical Pharmacology
• Location: US (Remote) or China (Shanghai or Beijing)
• A competitive total compensation and benefits package and internal growth opportunities
Job Description
General Position Summary:
A Clinical Pharmacologist will design, conduct, analyze, and report on clinical pharmacology studies and be responsible for providing clinical pharmacology components of protocols, clinical development plans, and regulatory documents. He/She will work closely in collaborative manner with cross-functional teams. He/She will complete assigned work in a resourceful and self-sufficient manner and have the ability to effectively communicate through verbal and written communication. The candidate will have a good knowledge of related disciplines which interact with the Clinical Pharmacology activities. We emphasize on the candidate’s quantitative pharmacology skills, scientific reasoning, regulatory affairs skills, written and verbal communication skills, study design and report writing skills.
Key Responsibilities:
• Prepare clinical pharmacology summary documents (CTD module sections 2.5 and 2.7) for regulatory submission.
• Contribute to clinical pharmacology sections of clinical study protocols, study analysis plans, clinical study reports and clinical development plans.
• Lead clinical pharmacology studies and perform PK (e.g., NCA analysis) and PK/PD analyses.
• Prepare standalone PK/PD reports or PK/PD section of Clinical Study Report (CSR).
• Collaborate and/or co-direct modeling plans or build on prior analyses to guide and/or assist with PK/PD modeling and simulations.
• Serve as clinical pharmacology lead in cross-functional study team settings, providing oversight of protocol conduct and internal decision points, data analyses, presentation of PK findings, and final PK and PK/PD report writing regarding pharmacology components of clinical studies.
• Collaborate with biostatistician, clinical operation, bioanalytical scientist and clinician for the execution and management of Phase I-III studies.
• Provide human dose recommendation for FIH and PoC studies based on quantitative translation of preclinical and clinical Phase I PK and PK/PD data.
• Assist in contract research organization management regarding clinical pharmacology studies.
• Maintain a high standard for good clinical practice, compliance and ethics.
Qualifications:
• Minimum of 3 years (PhD) or 5 years (MSc) of experience working as a clinical pharmacologist or pharmacometrician within biotech/ pharmaceutical industry.
• Preparation of clinical pharmacology summary documents (CTD module sections 2.5 and 2.7) for regulatory submission.
• Non-compartmental pharmacokinetic (PK) and PK/PD analyses.
• Understanding of PK, PK/PD and drug metabolism, and ability to apply PK and PK/PD concepts, including modeling and simulation to clinical trial design.
• Ability to translate PK findings into potential clinical impact.
• Strong technical proficiency in pharmacokinetic software (e.g., WinNonlin, Phoenix NLME, etc.).
• Skills with commercial PBPK software is preferred, but not required.
• Communicate clearly in verbal and written communications in both English and Chinese.
Company Information:
Asieris Pharmaceuticals(688176.SH), founded in March 2010 and headquartered in Shanghai, China, is a global innovative clinical stage pharma company specializing in discovering new drugs for the treatment of genitourinary tumors and other major diseases. We aim to become a leading global specialty pharma that integrates R&D, manufacturing and commercialization in genitourinary diseases. Two core products, Vesique® (APL-1202) and Cevira® (APL-1702), targeting at addressing the global unmet needs for the treatment of bladder cancer and cervical precancerous lesions, respectively, are currently in Phase III/pivotal clinical development. Asieris was named as one of the Top 30 Chinese Innovative Enterprises in Small Molecule Drugs in October 2021 at a conference organized by MENET.
Interested candidates please feel free to send your CV to Ms. Tracy Yu, Asieris Human Resources: jmyu@asieris.cn
