Job Title: Remote Clinical Pharmacologist
Location: Remote
Join our team as a Clinical Pharmacologist, working remotely to support our client’s pharmaceutical projects. You’ll be a key player in the development and execution of clinical pharmacology strategies, contributing to the success of early to late-stage programs.
Job Responsibilities:
- Serve as the Clinical Pharmacology Lead, setting clinical development plans for early to late-stage programs.
- Support PK/PD aspects of clinical studies, including development of synopsis/protocol, review of statistical and clinical pharmacology data analysis plans, and CSR.
- Oversee PK/PD data analyses, including non-compartmental PK, population PK and PK/PD, and other modeling and simulation activities.
- Contribute to regulatory documents such as Investigator Brochures, Labeling, and documents for regulatory meetings and filings.
Skills Required:
- A Ph.D. or equivalent degree in clinical pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, statistics, or a related field.
- Minimum of 12 years of full-time experience in a clinical pharmacology role within the pharmaceutical or biotechnology industry.
- At least 8 years of direct experience working on large molecule therapeutic modalities or biologics.
- Proven success in leading NDA and/or BLA submissions, with a strong track record of regulatory accomplishments.
- Exceptional verbal and written communication skills, with keen attention to detail and organizational proficiency.
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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