We have a current opportunity for a AD Pharmacometrics on a permanent basis. The position will be based in California or Massachusetts. For further information about this position please apply.
Job Summary: The Associate Director of Pharmacometrics will lead the pharmacometrics strategy for clinical programs across multiple indications/ disease areas. This role involves developing and implementing pharmacometric methodologies to address research and development objectives, influencing drug development and adoption decisions, and contributing to regulatory submissions.
Key Responsibilities:
- Provide global strategic pharmacometrics leadership for clinical development programs of medium to high complexity.
- Develop, write, and execute pharmacometrics analysis plans, and deliver comprehensive reports on results.
- Define and drive pharmacometrics contributions to regulatory/submission strategy and related documents (e.g., briefing books, clinical pharmacology summaries, responses to Health Authority questions).
- Represent the pharmacometrics function at global regulatory hearings, advisory committee meetings, and other regulatory interfaces.
- Integrate pharmacometrics information to support drug development milestones and decision boards.
- Present at various departmental and cross functional teams such as study teams, Clinical Pharmacology leadership team
- Identify alternative strategic options to mitigate risks in clinical programs.
- Lead and contribute to integrated evidence generation using disease progression and PKPD modeling techniques with varied data sources, including Real World Data.
- Ensure alignment of the analytics team (biometrician, data management, database programming, medical and scientific writing) on the pharmacometrics strategy and execution.
Qualifications:
- PhD within Pharmacology, Pharmacokinetics, Pharmaceutics, Data Science, Statistics, or related fields.
- 4+ years of relevant industry experience in population PKPD analysis.
- Deep understanding of clinical pharmacology principles and drug development processes.
- Extensive experience with PK/PD software packages such as NONMEM, Monolix, and R.
- Strong leadership and project management skills.
- Excellent communication and presentation skills..
Benefits:
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan with company match.
- Opportunities for professional development and career advancement.
- Flexible working arrangements, including hybrid work options.
