Director, Clinical Pharmacology & Quantitative Pharmacology (CPQP)- Oncology

AstraZeneca•Gaithersburg, MD

1d•Hybrid

About The Position

Are you ready to lead model-informed drug development that changes how cancer medicines are discovered and delivered? As Director, Clinical Pharmacology & Quantitative Pharmacology, you will set clinical pharmacology strategy across a diverse oncology portfolio, converting sophisticated quantitative insight into crucial program choices and regulatory confidence that accelerates impact for patients. You will champion a culture of MIDD, integrate advanced modeling with novel biomarkers and endpoints, and develop early and late development plans that bring clarity faster. How would you bring to bear groundbreaking clinical pharmacology to sharpen benefit–risk understanding and drive go/no-go decisions with precision? Working across functions and with external partners, you will evaluate licensing opportunities, build drug–disease models that advise trial develop and dose selection, and grow capabilities through mentoring and knowledge sharing—creating a scalable foundation for consistent, high‑quality decision making.

Requirements

Leadership in developing and embedding a culture supportive of MIDD in oncology, with influence across partners, stakeholders, and regulators.
Ability to plan and implement state-of-the-art clinical pharmacology approaches that drive portfolio value and enable go/no-go decision making.
Evidence-based and forward-thinking input spanning pre-clinical, clinical, and post-approval development.
Supervision, guidance, and delivery of oncology clinical pharmacology plans across early and late development.
Experience supporting evaluation of candidates for in- and out-licensing.
Contribution to drug–disease models alongside other modeling techniques for decision support, in collaboration with internal and external partners.
Support for discipline leadership in strategy, scientific operations, and business management.
Proven peer review and mentoring across therapeutic areas.
Dedication to providing education and sharing expertise to develop the Clinical Pharmacology field.
ctive monitoring of emerging techniques and implementations relevant to clinical pharmacology and MIDD.
Established external presence through speaking engagements and publications.
Ensuring alignment of clinical pharmacology plans with current regulatory expectations.

Nice To Haves

Experience integrating quantitative pharmacology alongside innovative biological indicators, AI-enabled analyses, innovative endpoints, and modern trial builds.
Track record of leading cross-functional, global teams to deliver sophisticated clinical pharmacology strategies at pace.
Familiarity with emerging and non-traditional drug modalities and their clinical pharmacology considerations.
Strong record of impactful publications and scientific presentations that influence practice or policy.
Ability to translate sophisticated modeling outputs into clear, actionable insights for diverse stakeholders, including senior leaders and regulators.
Experience collaborating with external consortia, academic partners, or industry groups to advance MIDD methodologies.

Responsibilities

Model-Informed Drug Development Leadership: Build and embed a culture encouraging of MIDD in oncology; influence partners, stakeholders, and regulators on its value and application to elevate decision quality and speed.
Portfolio Clinical Pharmacology Strategy: Plan and complete groundbreaking clinical pharmacology approaches with direct value across the portfolio, enabling clear decision points and optimized development paths.
End-to-End Development Input: Provide scientific and strategic feedback into pre-clinical, clinical, and post-approval plans to ensure coherent, data-driven strategies that reduce uncertainty.
Early and Late Development Oversight: Guide the supervision, support, and application of clinical pharmacology strategies in oncology through both early and late phases, managing dose selection, exposure–response analysis, and risk management.
Licensing Evaluation: Support assessment of candidates for in- and out-licensing, using quantitative evidence to assess opportunity, risk, and strategic fit.
Quantitative Modeling: Contribute to drug–disease models and other modeling approaches to support internal and external decision making, collaborating with internal teams and external partners when relevant.
Discipline and Business Support: Partner with the Oncology and discipline lead on strategy, scientific operations, and business management to align priorities and resources.
Peer Review and Mentorship: Provide peer review and mentoring within and across therapeutic areas, strengthening scientific difficulty and consistency.
Capability Building: Deliver training and knowledge sharing to advance the Clinical Pharmacology discipline and scale best practices.
Methodology Horizon Scanning: Supervise internal and external environments for relevant new methodologies and applications to keep approaches current and competitive.
External Scientific Profile: Increase AstraZeneca’s external profile in clinical pharmacology/MIDD through speaking engagements and publications in recognized journals to build industry thinking.
Regulatory Alignment: Ensure clinical pharmacology strategies align with current regulatory expectations, supporting successful submissions and interactions.