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Associate Director Pharmacometrics

6+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: Ph.D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Director Pharmacometrics
Company: Novartis Pharmaceuticals UK Ltd.
Location: London (Hybrid, 3 days per week or 12 days per month in office)
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular
Shift Work: No


Role Purpose

As an Associate Director Pharmacometrics, you will be responsible for leading the pharmacometrics strategy in clinical development programs across multiple indications or a disease area. You will provide strategic expertise in pharmacometrics for regulatory submissions and contribute directly to critical decisions in drug development and adoption, working closely with internal and external stakeholders.

Key Responsibilities

  • Global Leadership in Pharmacometric Strategy:

    • Lead pharmacometrics for clinical programs of medium to high complexity.
    • Represent the Global Project Teams as the pharmacometrics expert in internal and external discussions.
  • Analysis Plans & Reporting:

    • Develop, write, and execute pharmacometrics analysis plans.
    • Deliver detailed reports on results, contributing to strategic decision-making.
  • Regulatory & Submission Contributions:

    • Define pharmacometrics contributions to regulatory strategies and documents (e.g., briefing books, clinical pharmacology summaries, responses to Health Authority inquiries).
    • Represent pharmacometrics in global regulatory hearings and advisory meetings.
  • Risk Mitigation & Evidence Generation:

    • Drive integration of pharmacometrics data to support drug development milestones and decision boards.
    • Identify alternative strategies to mitigate clinical program risks.
    • Contribute to Integrated Evidence Generation, using modeling techniques and real-world data.
  • Collaboration & Coordination:

    • Ensure alignment of the Analytics team (biometricians, data management, medical writing) on pharmacometrics strategy and execution.

Experience & Qualifications

  • Education:

    • Ph.D. in pharmacology, biology, engineering, mathematics, statistics, or a related field with significant modeling-related content.
  • Experience:

    • More than 6 years’ experience in model-based methods for pre-clinical and clinical drug development.
    • Proven track record in developing pharmacometrics excellence both internally and externally.
    • Experience contributing to global scientific initiatives and policy shaping.
  • Leadership:

    • Demonstrated scientific leadership in clinical development strategies and modern program/trial design methodologies.

Why Novartis?

Novartis is committed to creating a diverse, inclusive workplace where innovation thrives, and people collaborate to deliver breakthrough medicines. Working at Novartis means being part of a community passionate about making a difference in patients' lives.

Commitment to Diversity & Inclusion

Novartis strives to foster an inclusive work environment that reflects the diverse communities we serve.

Join the Novartis Network

Not the right role? Join the Novartis talent network to stay updated on future career opportunities: Novartis Talent Network.

Benefits & Rewards

Explore the comprehensive benefits package Novartis offers to help you thrive personally and professionally: Novartis Benefits & Rewards.

EEO & Accessibility

Novartis is an Equal Opportunity Employer, committed to diversity and accessibility. If you require accommodations during the application process, contact us at: us.reasonableaccommodations@novartis.com.