Position: Clinical Pharmacology Consultant
Location:Remote, US
Length:3 Month Contract
Please no agencies. Direct employees currently authorized to work in the United States - no sponsorship available
Job Description:
The Clinical Pharmacology Consultant will execute clinical pharmacology strategies to help advance the clinical development of a diverse pipeline of therapeutic modalities (e.g., small molecules, biologics, nucleic acid therapeutics, and gene therapies). The consultant will represent Clinical Pharmacology on internal drug development project teams and author clinical pharmacology sections of documents and responses to health authority queries to support regulatory submissions. The consultant will proactively collaborate across functions within the organization to complete Clinical Pharmacology deliverables for project teams.
Essential Duties and Responsibilities:
- Represent Clinical Pharmacology on internal drug development project teams
- Drive execution of clinical pharmacology strategies for assigned development projects
- Evaluate and perform hands-on analysis of clinical PK/PD data
- Ensure timely and accurate communication of study results and interpretation to project teams
- Respond to clinical pharmacology-related queries from global health authorities
- Author clinical pharmacology sections of clinical study reports, protocols, investigator brochures, and other regulatory submissions
- Manage population PK/PD modeling and exposure response analyses at CROs to support dosing strategies and regulatory submissions
- Ensure appropriate quality of documentation compatible with requirements for global regulatory submissions
Qualifications:
- PhD or equivalent in pharmacokinetics, pharmacology, pharmaceutical sciences, or relevant science with 10+ years of industry experience
- Demonstrated understanding of translational PK and clinical pharmacology with industry experience in clinical development
- Experience in drug development of diverse modalities (e.g., small molecules, biologics, nucleic acid therapeutics, and gene therapies) for rare diseases is preferred. Ability to rapidly master new scientific areas is essential
- Demonstrated proficiency with hands-on noncompartmental and compartmental PK analyses and data reporting using Phoenix WinNonlin
- Demonstrated experience with population PK modeling, exposure response analysis, and PK/PD modeling is desired
- Capable of independently authoring and delivering Clinical Pharmacology sections of regulatory submissions
- Understanding of bioanalytical measurement techniques for drug candidates spanning diverse modalities and therapeutic areas
- Clear and influential communicator and collaborator, capable of establishing strong cross-functional partnerships with internal and external stakeholders
- Knowledge of drug development and FDA and ICH guidance documents
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Come see why DPC has achieved:
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor.
- Voted 'Best Staffing Firm to Temp/Contract For' 8 consecutive years in a row by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine.
As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!
www.LoveYourJob.com
|
Digital Prospectors
Apr 20, 2026