Manager of Clinical Pharmacology

6 days ago

Shanghai, Shanghai, China Duality Biologics Full time CN¥1,200,000 - CN¥2,000,000 per year

We are seeking a skilled Manager of Clinical Pharmacology to join our team. This role will provide clinpharm input on study design, execution, and report of clinical pharmacology studies, hand on or drive PK/PD modeling & simulation activities to support drug development programs. The ideal candidate will be responsible for performing pharmacokinetic and pharmacodynamic analyses, developing models, and generating data-driven insights to guide program decisions.

Responsibilities:

  1. Provide clinical Pharmacology expertise to the projects, implement strategic CP plans for assigned programs, including dose optimization, drug-drug interaction (DDI), and formulation bridging, etc.
  2. Collaborate closely with cross-functional teams: Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Formulation Development, and Safety to ensure CP strategies align with program goals.
  3. Responsible for statistical analysis and data analysis related to clinical pharmacology, including NCA, PK/PD, PBPK, concentration-QT and Exposure-Response (ER) analyses, etc.
  4. Contribute to the clinical pharmacology sections in Phase I/II/III study protocols, study summary reports, Investigator's Brochures, and IND/HA interaction/BLA submission documents.
  5. Support the clinical pharmacology platform, including the development of SOPs/WIs and templates.
  6. Collaborate closely with DMPK, Toxicology (Tox), biology, pharmacology, and clinical teams to bridge nonclinical and clinical PK/pharmacodynamic/toxicity data to support clinical study design, data interpretation, and program-level decision-making
  7. With the study team, tracks emerging clinical pharmacology aspects of the compound, and keeps ensure functional alignment of the compound with the entire DB portfolio.
  8. Serve as educator for the clinical study team regarding the specifics of clinical pharmacology knowledge, and its impact on clinical development of the compound (small and large molecules).

Requirements:

  1. Master or PhD in Clinical Pharmacology, Pharmacometrics, Pharmacy, or a related field.
  2. Minimum of 3-5+ years of industry experience in clinical pharmacology, with a proven track record of successfully leading the clinical pharmacology components of drug development programs.
  3. Proficient in using MIDD tools, such as WinNonlin, NONMEN or Monolix, R or python;
  4. Familiar with CFDA/FDA/EMA clinical pharmacology relevant regulations;
  5. Proactive, and quick to learn; Excellent communication and coordination skills to work with diverse teams (clinical, statistical, regulatory, etc.)..

  • Manager, Clinical Research

    6 days ago

    Shanghai, Shanghai, China MSD Full time CN¥175,000 - CN¥250,000 per year

    Job DescriptionAbout the Role:The position will provide domain expertise in modeling simulation to inform clinical pharmacology and drug development support of the company's pipeline. This position will interact with clinical pharmacology leads and other members of cross-disciplinary teams in support of multiple early- and late-stage programs. This position...

  • Clinical Research Physician, EMP

    6 days ago

    Shanghai, Shanghai, China Eli Lilly and Company Full time CN¥120,000 - CN¥180,000 per year

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Pharmacology Director药理总监

    6 days ago

    Shanghai, Shanghai, China Sironax Full time CN¥900,000 - CN¥1,200,000 per year

    Role/Function Summary:职位/职能概述:Pharmacology director will be responsible for driving projects from early target discovery through to IND submission and supporting the translational research for related clinical stage projects. This role will possess a deep scientific background in CNS diseases, a proven track record of leading successful drug...

  • Clinical Pharmacist

    6 days ago

    Shanghai, Shanghai, China 上海和睦家医院 Full time CN¥80,000 - CN¥120,000 per year

    工作职责General Statement of Duties:Participating in morning medical report with physicians. Establish pharmacy record for inpatient patients and follow drug therapy. Assist physician in monitoring drug therapy's safety and efficacy. Support staff pharmacists in resolving daily pharmacy issues, assist pharmacy manager in training and supervise staff...

  • Clinical Project Manager

    6 days ago

    Shanghai, Shanghai, China PSI CRO Full time CN¥120,000 - CN¥240,000 per year

    Company Description PSI is an award-winning full-service CRO, bringing together more than 2,700 dynamic and knowledgeable individuals working to help impact the future of medicine in more than 60 countries around the world. We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new...

  • Medical Manager

    4 days ago

    Shanghai, Shanghai, China 英谛捷医药科技咨询(上海)有限公司 Full time

    该职位来源于猎聘 Job DescriptionResponsible for Medical orientation, Strategy, story writing and ReviewDeeply understand Pharmaceutical client's requirements and development trend related to medical field, have good communication with clients and make proposal regarding medical promotion strategy, medical content and project plan.Cooperate closely...

  • Clinical Development Medical Manager

    2 days ago

    Shanghai, Shanghai, China Novartis Full time CN¥1,200,000 - CN¥2,400,000 per year

    BandLevel 4Job Description Summary-Oversees the execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials...

  • Sr. Manager, Clinical Research

    6 days ago

    Shanghai, Shanghai, China MSD Full time CN¥600,000 - CN¥1,200,000 per year

    Job DescriptionPhysician, OncologyAs Clinical director/scientist in oncology China Product Development Team (cPDT), clinical research physician will play key leadership role for the clinical development in China. This individual will be responsible and accountable for the development of China development plan. Clinical research partners closely with...

  • Senior/Executive Director, Biologics

    4 days ago

    Shanghai, Shanghai, China Sironax Full time CN¥120,000 - CN¥180,000 per year

    Position SummaryWe are seeking an accomplished leader to join our team asSenior/Executive Director of Antibody Development. This role will own the end-to-end design and build-out of our antibody-based brain delivery platforms and derivative therapeutics. The ideal candidate shall have comprehensive expertise in the full biologics development lifecycle, from...

  • Clinical Quality Manager

    4 days ago

    Shanghai, Shanghai, China Pfizer Full time CN¥120,000 - CN¥240,000 per year

    Purpose:Ensure implementation and oversight of the GCP Quality Management System (QMS) for clinical development activities in China, aligned with global standards and regulatory requirements, while driving digital and AI-related initiatives.Key ResponsibilitiesQuality Management & ComplianceImplement GCP QMS strategy locally; maintain Level 1 GCP quality...