Senior Clinical Pharmacologist

Allergan; Lincoln (NE); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading company in health solutions is seeking a Clinical Pharmacology Representative to drive the strategy for clinical pharmacology in China. The position requires advanced education in relevant fields and several years of experience in the industry. Candidates should have excellent interpersonal skills, strategic thinking capabilities, and effective communication abilities. Join a diverse team committed to innovation and improving health outcomes.

Qualifications

• 3+ years in clinical pharmacology with PhD
• 7+ years with Master's degree
• Experience in multinational corporations required.

Responsibilities

• Develop clinical pharmacology strategies for China studies.
• Review and contribute to CP documents for submissions.
• Manage communications with local KOLs.

Skills

Interpersonal skills

Strategic thinking

English communication

Education

Master's degree or higher in pharmacy, pharmacology, biology, medicine

PhD preferred

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

• Responsible for China Clinical Pharmacology strategy (including intensive PK, popPK, PK/PD, E-R, Immunogenicity, and QT analysis) to ensure: 1) smooth opening of late phase study in China; 2) compliance with relevant China CP regulations for successful NDA registration.
• Serves as the clinical pharmacology representative in assigned China ASTs/IEST and TARM meetings.
• Acts as the (China) clinical pharmacology representative in assigned (global) study teams to facilitate study execution.
• Works closely with related asset global Clinical Pharmacology representatives to exchange relevant information and provide advice from Chinese regulatory and scientific perspectives to support China CP strategy and study execution.
• Serves as an expert in CP in China, maintaining close connections with global CP for support and collaboration.
• Provides critical review and contributions for China CP documents for CTA and NDA submissions, such as study protocols/reports, population PK reports, and exposure/response analysis reports.
• Contributes to and reviews the CP sections of local CDE consultation documents and submission documents (e.g., clinical overviews, IB, CTD, dose justifications, study design justifications, China development plans).
• Participates in local CDE consultation meetings and facilitates CP communication with regulatory agencies.
• Interprets CDE’s CP requirements scientifically and ensures their implementation during NDA processes.
• Manages local KOLs and coordinates communication between China and global teams.
• Delivers clinical pharmacology knowledge to multidisciplinary teams to ensure timely CP deliverables.
• Streamlines clinical pharmacology processes to improve efficiency.
• Reviews and comments on clinical pharmacology guidelines.

Qualifications

• Master's degree or higher in pharmacy, pharmacology, biology, medicine, or related fields; PhD preferred.
• At least 3 years of industry experience in clinical pharmacology with a PhD, or 7+ years with a Master’s degree.
• Excellent interpersonal skills and ability to interact effectively with stakeholders.
• Strategic thinking capabilities.
• Proficiency in English communication, both written and spoken.
• Experience working in multinational corporations is required.

Additional Information

AbbVie is an equal opportunity employer committed to integrity, innovation, and community service. We welcome applicants from all backgrounds, including veterans and disabled individuals.

For US & Puerto Rico applicants, more information is available at https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. To request accommodations, visit https://www.abbvie.com/join-us/reasonable-accommodations.html.