Associate Director/Director, Pharmacometrician

3 months, 3 weeks ago
Full-time
Lead
Data Science and Analytics
Allucent

Allucent

Allucent is a full-service Clinical Research Organization that specializes in providing high-quality solutions tailored to the unique challenges faced by small to mid-sized biotech firms in the development and approval of new therapies.

Pharmaceuticals
1K-5K
Founded 1994

Description

  • Lead and conduct population PK analyses using advanced modeling tools and methodologies.
  • Develop and implement innovative approaches to improve the efficiency and accuracy of PK analysis.
  • Design, analyze, and interpret clinical pharmacology studies, including renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, and MAD studies.
  • Provide guidance on pharmacokinetic sampling and dosing strategies to optimize study design.
  • Advise clients on clinical pharmacology strategy and own key deliverables.
  • Develop clinical pharmacology plans and contribute to program-level decision making.
  • Author and review PK reports and clinical pharmacology sections of regulatory documents.
  • Represent clients in interactions with regulatory agencies.
  • Support business development and relationship management activities.
  • Mentor pharmacometricians and contribute scientific leadership within the CPMS environment.

Requirements

  • 6-10 years of relevant experience in drug development, clinical pharmacology, and pharmacometrics.
  • Life science, healthcare, or business degree.
  • Regulatory experience, including regulatory report writing.
  • Experience with regulatory submissions such as INDs, CTAs, regulatory meetings, and NDA/BLA/MAA submissions.
  • Proficiency in NONMEM, Pirana, and R software preferred.
  • Strong analytical thinking and ability to deliver high-impact insights.
  • Client-focused mindset with leadership capability in fast-paced environments.
  • Strong communication and business acumen.
  • Excellent organizational, negotiating, and financial skills.

Benefits

  • Comprehensive benefits package, depending on location.
  • Competitive salary, depending on location.
  • Departmental study and training budget for professional development.
  • Flexible working hours within reason.
  • Remote or hybrid work options depending on location.
  • Leadership and mentoring opportunities.
  • Internal growth opportunities and career progression.
  • Eligibility for spot bonus awards and loyalty awards.

Interested in this position?

Apply directly on the company website

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