Lead Clinical Pharmacologist in Virology

2 weeks ago

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

Position Overview

As a Senior Clinical Pharmacologist specializing in Virology, you will play a pivotal role in steering clinical pharmacology investigations with a focus on HIV therapeutics. Your expertise will guide projects from initial human trials through to regulatory approval and post-marketing evaluations, including pediatric considerations. You will collaborate closely with multidisciplinary teams, overseeing various facets of clinical pharmacology initiatives.

Key Responsibilities

  • Contribute to the development strategies and clinical plans for assigned therapeutic products.
  • Author comprehensive clinical pharmacology plans for multiple products within the designated therapeutic area.
  • Lead and manage the design and execution of complex clinical pharmacology studies, ensuring effective cross-functional team collaboration.
  • Develop study protocols and data analysis plans, incorporating modeling and simulation methodologies.
  • Facilitate discussions on study protocol reviews, focusing on scientific and procedural elements of pharmacology study design.
  • Collaborate with internal teams and external study sites to implement and monitor clinical pharmacology studies, addressing any arising clinical issues.
  • Direct resources and activities for both internal and external study partners, ensuring alignment with project goals.
  • Manage timelines and resources to guarantee the efficient execution of clinical pharmacology studies.
  • Conduct pharmacokinetic-pharmacodynamic (PK-PD) analyses and contribute to study documentation, data management plans, and scientific presentations.
  • Analyze and interpret data for clinical and regulatory submissions, ensuring compliance with industry standards.
  • Present project updates and critical milestones to stakeholders and cross-functional partners.
  • Support business development initiatives as a clinical pharmacology expert when necessary.
  • Act as the clinical pharmacology representative for project teams in interactions with regulatory bodies.
  • Proactively identify potential challenges in clinical trials and devise innovative solutions.
  • Ensure adherence to regulatory standards and Good Clinical Practice (GCP) guidelines throughout study conduct.

Qualifications

Candidates should possess a PharmD or PhD in pharmaceutical sciences, pharmacology, or a related field, along with a minimum of 5 years of relevant research or clinical experience.

Additional Requirements

  • Proven experience in the Virology therapeutic area.
  • Demonstrated ability to lead cross-functional project teams in drug research or development.
  • Expertise in clinical pharmacology study design, protocol development, and regulatory submissions.
  • Strong analytical skills in PK-PD and related analyses.
  • Excellent communication and organizational abilities.
  • Willingness to travel as needed.

Compensation and Benefits

The salary range for this position is competitive, taking into account various factors such as experience and qualifications. Additional benefits may include performance-based bonuses, stock options, and comprehensive health insurance plans.

Equal Opportunity Employer

Gilead Sciences, Inc. is committed to fostering a diverse workforce and ensuring equal employment opportunities for all individuals, regardless of race, gender, age, or other characteristics.

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