Associate Director Quantitative Pharmacology

About the role

The Associate Director will lead model-informed drug development strategies supporting one or more therapeutic areas across modalities including antibodies, siRNA, and gene therapies. This role combines scientific depth with cross-functional leadership to inform dose selection, trial design, and regulatory strategy from early development through submission.

Responsibilities

• Driving model-informed development (MIDD) and pharmacometrics strategies in partnership with Clinical Pharmacology, Biostatistics, Clinical and Translational teams to support regulatory and clinical decision-making.
• Leading the QP evaluation of one or more assets, accountable for timely delivery of population PK/PD, exposure–response, and translational modeling analyses.
• Representing QP at program and governance meetings, communicating quantitative insights clearly to non-modeling audiences.
• Contributing to regulatory interactions and authoring key components of regulatory documents related to QP (e.g., IB, briefing books, etc.).
• Mentoring and developing junior scientists and fostering a culture of scientific rigor and collaboration.
• Identifying and implementing process improvements, new modeling approaches, and innovative quantitative tools to enhance efficiency and impact.
• Ensuring analyses and documentation are of the highest scientific quality and regulatory compliance.

Requirements

• PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or a related field with 6+ years of post-doctoral or industry experience; or MS with 9+ years of relevant experience.
• Demonstrated expertise in population PK/PD, exposure–response, or mechanistic modeling (systems biology, or QSP) using tools such as NONMEM, Monolix, Simulx, MATLAB/Simbiology and R.
• Proven track record of delivering analyses supporting regulatory submissions and engaging directly with agencies (e.g., FDA, EMA, PMDA).
• Hands-on experience with a broad range of quantitative and computational tools and a strong publication record.

Qualifications

• Exceptional communication and interpersonal skills, with the ability to influence and partner effectively across technical and non-technical teams.

Skills

• Strong collaboration and leadership skills, influencing cross-functional teams without formal authority.
• Independent design, execution, and oversight of multiple modeling workstreams simultaneously.

Benefits

To Be Considered For This Role, You Must Have:

• PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or a related field with 6+ years of post-doctoral or industry experience; or MS with 9+ years of relevant experience.
• Demonstrated expertise in population PK/PD, exposure–response, or mechanistic modeling (systems biology, or QSP) using tools such as NONMEM, Monolix, Simulx, MATLAB/Simbiology and R.
• Proven track record of delivering analyses supporting regulatory submissions and engaging directly with agencies (e.g., FDA, EMA, PMDA).
• Hands-on experience with a broad range of quantitative and computational tools and a strong publication record.
• Exceptional communication and interpersonal skills, with the ability to influence and partner effectively across technical and non-technical teams.

Pay

$176,100.00 - $287,300.00 annually

Schedule

Full-time