Vice President of Clinical Pharmacology

2 weeks ago

South San Francisco, California, United States Recruits Lab (We're hiring) Full time

Are you prepared to lead transformative precision medicine initiatives in oncology? Recruits Lab (We're hiring) is in search of an exceptional Vice President of Clinical Pharmacology to become a key member of our innovative team.

About Us: We are at the forefront of precision medicine in oncology, dedicated to the discovery and advancement of targeted therapies through advanced DNA sequencing and molecular diagnostics. Our commitment to innovation and teamwork is driving us toward a future where every patient receives personalized treatment tailored to their unique needs.

Your Role: In the capacity of Vice President of Clinical Pharmacology, you will be instrumental in shaping the trajectory of oncology therapeutics. Your leadership will guide clinical pharmacology initiatives and influence regulatory strategies, ensuring the successful development and approval of novel therapies. You will leverage advanced pharmacometrics techniques and contribute high-level scientific insights to tailor clinical pharmacology and DMPK strategies. Your guidance will be crucial in maintaining project timelines and budgets, fostering a culture of excellence and innovation.

Key Responsibilities:

  • Provide expert oversight on all elements of clinical pharmacology initiatives supporting drug discovery and development.
  • Draft clinical protocols, study reports, and data evaluations (exposure/efficacy/safety) to facilitate the development and approval of new products.
  • Utilize advanced pharmacometrics methodologies, including population pharmacokinetic and pharmacokinetic-pharmacodynamic modeling, exposure-response assessments, and physiological-based pharmacokinetic modeling.
  • Compose, review, and refine relevant sections of regulatory submissions (INDs, NDAs, IBs) and address regulatory inquiries.
  • Ensure compliance with timelines and budgets for clinical pharmacology studies and initiatives.
  • Lead the preparation of scientific publications, including abstracts, posters, presentations, and manuscripts.
  • Engage and oversee CROs to support pharmacometrics analyses, ensuring adherence to established protocols, quality standards, and timelines.

Qualifications:

  • A Ph.D. or PharmD with a minimum of 10 years of experience in pharmaceutical sciences, pharmacokinetics, clinical pharmacology, chemistry, or related disciplines.
  • Extensive expertise in pharmacometrics analysis, encompassing study design, data interpretation, and modeling simulation.
  • Proficiency in modeling software such as Phoenix WinNonlin, NONMEM, R, SAS, or similar tools.
  • Strong understanding of model-informed drug development, DMPK-Clinical Pharmacology principles, and regulatory standards.
  • Experience in managing external partnerships, including CROs and consultants.
  • Exceptional interpersonal, organizational, and collaborative skills to effectively communicate with external partners and internal teams.
  • Adept at thriving in a fast-paced, dynamic environment while maintaining a positive attitude and strong work ethic.

Why Join Us:

  • Competitive compensation package.
  • Comprehensive benefits, including medical, dental, and vision coverage, retirement plans, and wellness initiatives.
  • Annual performance bonuses and equity opportunities for full-time employees.
  • An inclusive and collaborative workplace where your contributions are valued and your voice is heard.

Become Part of Our Team: If you are passionate about advancing innovation in oncology and making a significant impact, we encourage you to consider this opportunity with us.

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