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AstraZeneca · 1 day ago

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

Gaithersburg, MD

Full-time

Onsite

Director/Executive

$179K/yr - $269K/yr

AstraZeneca is a leading company in the field of oncology, seeking a Director of Clinical Pharmacology & Quantitative Pharmacology to lead model-informed drug development. The role involves setting clinical pharmacology strategy, integrating advanced modeling with biomarkers, and mentoring teams to enhance decision-making in drug development.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

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

Plan and complete groundbreaking clinical pharmacology approaches with direct value across the portfolio, enabling clear decision points and optimized development paths

Provide scientific and strategic feedback into pre-clinical, clinical, and post-approval plans to ensure coherent, data-driven strategies that reduce uncertainty

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

Support assessment of candidates for in- and out-licensing, using quantitative evidence to assess opportunity, risk, and strategic fit

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

Partner with the Oncology and discipline lead on strategy, scientific operations, and business management to align priorities and resources

Provide peer review and mentoring within and across therapeutic areas, strengthening scientific difficulty and consistency

Deliver training and knowledge sharing to advance the Clinical Pharmacology discipline and scale best practices

Supervise internal and external environments for relevant new methodologies and applications to keep approaches current and competitive

Increase AstraZeneca’s external profile in clinical pharmacology/MIDD through speaking engagements and publications in recognized journals to build industry thinking

Ensure clinical pharmacology strategies align with current regulatory expectations, supporting successful submissions and interactions

Qualification

Model-Informed Drug DevelopmentClinical Pharmacology StrategyQuantitative ModelingRegulatory AlignmentPeer ReviewMentorshipEducationKnowledge SharingEmerging Methodologies MonitoringExternal Scientific ProfileLeadershipCollaboration

Required

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

Active 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

Preferred

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

Benefits

Short-term incentive bonuses

Equity-based awards for salaried roles

Commissions for sales roles

Qualified retirement programs

Paid time off (i.e., vacation, holiday, and leaves)

Health, dental, and vision coverage

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)