Lead Clinical Pharmacologist in Virology

1 week ago

Foster City, California, United States Gilead Sciences, Inc. Full time

Position Overview

As a Senior Clinical Pharmacologist specializing in Virology, you will take on a pivotal role in leading complex clinical pharmacology studies focused on HIV therapeutics. Your expertise will guide projects from initial human trials through to approval and post-marketing phases, including pediatric considerations. Collaborating with multidisciplinary teams, you will oversee various facets of clinical pharmacology initiatives.

Key Responsibilities

  • Contribute to product development strategies and clinical development plans as a vital member of the drug development team.
  • Author comprehensive clinical pharmacology plans for multiple products within the designated therapeutic area.
  • Lead and manage the design and execution of intricate clinical pharmacology studies, ensuring effective collaboration within cross-functional study teams.
  • Develop clinical pharmacology study protocols and analysis plans, integrating input from team members.
  • Facilitate discussions on study protocol reviews, focusing on scientific and procedural aspects of pharmacology study design.
  • Collaborate with cross-functional partners and study sites to implement and monitor clinical pharmacology studies, addressing any arising clinical issues.
  • Direct activities and resources for both internal and external study collaborators.
  • Manage timelines and resources to guarantee the timely and precise execution of clinical pharmacology studies.
  • Conduct pharmacokinetic-pharmacodynamic (PK-PD) analyses and provide clinical pharmacology insights for study documentation and scientific presentations.
  • Analyze and interpret data, authoring documents for clinical and regulatory submissions.
  • Present project updates and key milestones to cross-functional partners and stakeholders.
  • Support business development and due diligence activities as a clinical pharmacology authority.
  • Represent clinical pharmacology in interactions with regulatory agencies for assigned projects.
  • Proactively identify potential challenges in clinical trials and devise solutions based on established precedents and innovative thinking.
  • Ensure compliance with regulatory standards and industry best practices, including Good Clinical Practice and Gilead's Standard Operating Procedures.

Qualifications

We value diverse contributions to enhance patient care. Below are the qualifications and skills we seek for this role:

  • PharmD or PhD in pharmaceutical sciences, pharmacology, or a related field with over 5 years of relevant research or clinical experience.
  • Proven experience in the Virology therapeutic area.
  • Significant background in leading small cross-functional project teams in drug research or development.
  • Extensive experience in study concept and protocol design, authoring clinical pharmacology development plans, and conducting PK-PD analyses.
  • Demonstrated success in managing clinical project deliverables through matrix management.
  • Experience in supporting clinical publications and presentations is highly preferred.

Knowledge & Skills

  • Ability to learn quickly and adapt to changing environments.
  • Recognized for sustained scientific excellence and flexibility in project support.
  • Comprehensive understanding of FDA and EMA regulations, ICH guidelines, and GCP standards governing clinical studies.
  • Advanced knowledge of R&D processes and major disease areas, demonstrated through effective project support.
  • Strong business acumen applied to strategic scientific initiatives.
  • In-depth knowledge of PK-PD analyses and the physiological/pharmacological aspects of drug development.
  • Exceptional communication and organizational skills.
  • Willingness to travel as necessary.

The compensation for this position is competitive and considers various factors such as experience, qualifications, and geographic location. This role may also include eligibility for an annual bonus and stock-based long-term incentives, along with a comprehensive benefits package.

Equal Opportunity Employer

Gilead Sciences, Inc. is committed to fostering a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information, gender identity and expression, veteran status, or other non-job-related characteristics.

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