Unknown Company

Senior Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology

pa • Posted 2 weeks ago
Onsite Full Time Pharmacology

Primary Responsibilities

  • Lead and shape quantitative pharmacology strategy across oncology programs to inform key decisions (dose selection, trial design, go/no-go).
  • Develop and implement integrated model-informed drug development (MIDD) strategies across development stages.
  • Ensure modeling strategies align with regulatory expectations and business priorities.
  • Lead, mentor, and develop a team of QP2 scientists (performance, hiring, retention, deliverable oversight).
  • Serve as QP2 lead on assigned programs; represent QP2 in cross-functional teams/governance forums.
  • Collaborate with Translational, Clinical, and Biostatistics teams; partner with preclinical teams to translate findings into clinical plans.
  • Contribute to due diligence for business development/licensing.
  • Develop and contribute to regulatory strategies; author/review INDs, CSRs, CTD modules, NDA/BLA submissions; represent the company with regulators/conferences.

Minimum Education

  • Ph.D. in relevant discipline (≥10 years pharma industry experience) OR Master's/PharmD/equivalent (≥15 years, increasing responsibility/leadership).

Required Experience & Skills

  • Background in relevant fields (biopharmaceutics/pharma sciences/pharmacimetrics/mathematics/computational biology or related) and oncology disease knowledge.
  • Ability to lead interdisciplinary teams.
  • Experience developing quantitative strategies impacting pipeline decisions.
  • Experience independently authoring/defending marketing authorization filings (NDA/MAA).
  • Inclusive, high-performance collaboration; manage ambiguity.
  • Strong written/verbal communication and problem scoping/planning.

Required Skills

Clinical Development, Clinical Pharmacology, Cross-Functional Collaboration, Drug Development, Effective Written/Verbal Communication, Leadership, Oncology, Oncology Drug Development, Pharmacometrics, Regulatory Interactions/Responses, Stakeholder Relationship Management, Team Management, Translational PK/PD (PKPD).

Benefits

  • Eligible for annual bonus and long-term incentive (if applicable).

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Senior Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology in pa at Unknown Company

This position is listed as full time and onsite.

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