- Provide expert guidance on all aspects of clinical pharmacology programs supporting drug discovery and clinical development.
- Author clinical protocols, study reports, and data analyses (exposure/efficacy/safety) to support the development and registration of new products.
- Apply state-of-the-art pharmacometrics methodologies, including population pharmacokinetic and pharmacokinetic-pharmacodynamic modeling, exposure-response analyses, and physiological-based pharmacokinetic modeling.
- Write, review, and edit relevant sections of regulatory documents (INDs, NDAs, IBs) and respond to regulatory inquiries.
- Ensure adherence to timelines and budgets for clinical pharmacology studies and programs.
- Lead the writing of scientific publications, including abstracts, posters, oral presentations, and manuscripts.
- Engage and manage CROs to support pharmacometrics analyses and ensure compliance with agreed protocols, quality standards, and timelines.
- A Ph.D. or PharmD with a minimum of 10 years of industry experience in pharmaceutical sciences, pharmacokinetics, clinical pharmacology, chemistry, or related fields.
- Extensive experience in pharmacometrics analysis, including study design, data analysis, and modeling simulation.
- Proficiency in modeling software packages such as Phoenix WinNonlin, NONMEM, R, SAS, or similar tools.
- Strong knowledge of model-informed drug development, DMPK-Clinical Pharmacology concepts, and regulatory requirements.
- Experience in managing external resources, including CROs and consultants.
- Excellent interpersonal, organizational, and teamwork skills are required to communicate effectively with external collaborators and internal project teams.
- Ability to thrive in a fast-paced, dynamic environment while maintaining a positive attitude and superior work ethic.
- Competitive salary range: $223,449 - $337,470 per year (Director level) | $273,771 - $337,470 per year (Senior Director level).
- Comprehensive benefits package, including medical/dental/vision coverage, retirement benefits, ESPP, and wellness programs.
- Annual bonus and equity refresh for full-time employees.
- An inclusive and collaborative work environment where your ideas are valued and your voice is heard.
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Director/Senior Director, DMPK and Clinical Pharmacology - San Francisco, United States - Recruits Lab (We're hiring)
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Description
Are you ready to pioneer groundbreaking precision medicine therapies in the field of oncology? Our client, a leading clinical-stage precision medicine oncology company, is seeking a visionary
Director/Senior Director of Pharmacokinetics and Clinical Pharmacology to join their dynamic team in South San Francisco, California.
Who They Are: This innovative company is revolutionizing the landscape of precision medicine oncology. They are committed to the discovery and development of targeted therapeutics using cutting-edge DNA sequencing and molecular diagnostics. With a relentless focus on innovation and collaboration, they are driving toward a future where every patient receives the right medicine for their specific needs.
Your Impact: As the Director/Senior Director of Pharmacokinetics and Clinical Pharmacology, you'll play a pivotal role in shaping the future of oncology medicine. From leading clinical pharmacology programs to driving regulatory decisions, your expertise will drive the development and registration of groundbreaking therapies. You'll apply state-of-the-art pharmacometrics methodologies and provide high-quality scientific knowledge to customize clinical pharmacology and DMPK plans. Your leadership will ensure adherence to timelines and budgets, fostering a culture of excellence and innovation.
What You'll Do:
What You'll Bring:
Why Join Them:
Join Their Team: If you're passionate about driving innovation in oncology medicine and making a meaningful impact, we want to hear from you Apply now to be part of this pioneering team.
This position requires onsite work at their facilities in South San Francisco, California, with partial work-from-home flexibility. All employees working in their facilities must be fully vaccinated against COVID-19, subject to reasonable accommodations.
Our client is an equal-opportunity employer. They do not discriminate in hiring or employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
