Director, Clinical Pharmacology - Los Angeles, United States - Meet

Description

Job Title:
Associate Director/Director, Clinical Pharmacology

Company Overview
Join a dynamic and innovative mid-sized biotech company dedicated to advancing therapies in the field of cardiometabolic diseases. Our client is located in the vibrant San Francisco Bay Area, where innovation meets collaboration. They are committed to making a difference in patients' lives through groundbreaking research and development efforts.


Position Overview:

We are seeking a highly skilled and motivated individual to join our client as an Associate Director/Director of Clinical Pharmacology.

This pivotal role will be responsible for leading clinical pharmacology activities to support the development of novel therapeutics targeting cardiometabolic diseases.

The successful candidate will play a key role in designing and implementing clinical pharmacology strategies, contributing to regulatory submissions, and providing scientific expertise to cross-functional teams.

Key Responsibilities:
Lead clinical pharmacology strategies to support drug development programs from early development through post-marketing phases.
Design and oversee clinical pharmacology studies, including pharmacokinetic, pharmacodynamic, and drug-drug interaction studies.
Analyze and interpret clinical pharmacology data to guide dose selection, regimen optimization, and safety assessments.

Collaborate cross-functionally with clinical development, regulatory affairs, translational medicine, and other teams to ensure alignment of clinical pharmacology strategies with overall development goals.

Contribute to regulatory submissions, including INDs, IBs, and BLAs, by preparing clinical pharmacology sections and responding to regulatory inquiries.

Stay abreast of current literature, industry trends, and regulatory guidelines in clinical pharmacology to inform decision-making and drive innovation within the organization.

Qualifications:

PhD or PharmD in Pharmacology, Pharmaceutical Sciences, or a related field with a minimum of 5 years of industry experience, or MS with 8+ years of industry experience.

Demonstrated expertise in clinical pharmacology, with a focus on drug development in the biopharmaceutical industry.
Experience in designing and conducting clinical pharmacology studies, including knowledge of PK/PD modeling and simulation techniques.
Strong understanding of regulatory requirements and guidelines related to clinical pharmacology and drug development.
Excellent communication skills with the ability to effectively collaborate with cross-functional teams and external stakeholders.
Proven track record of leadership, project management, and strategic thinking.

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