Clinical Development Medical Director, GU

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** Job Summary
** The Clinical Development Medical Director will provide medical and scientific leadership for a Phase 3 oncology clinical trial within prostate cancer.

The Clinical Development Medical Director will work in close partnership with the Clinical Scientist and cross-functional study team to oversee study conduct, medical monitoring, safety evaluation, data interpretation, and delivery of high-quality clinical and regulatory documents. The individual will also contribute to broader clinical development planning and ensure that study-level decisions remain aligned with the overall program strategy.

The role requires strong clinical judgment, scientific rigor, and the ability to lead through influence across a global matrix organization. The Medical Director will engage with investigators, external experts, health authorities, internal governance bodies, and colleagues across Clinical Operations, Safety, Regulatory Affairs, Biostatistics, Clinical Pharmacology, Medical Writing, and other partner functions.  ##
** Key Responsibilities**###
** Study-Level Clinical Development Leadership
*** Provide medical and scientific leadership for a Phase 3 oncology clinical trial within prostate cancer
* Partner with the Clinical Scientist and Clinical Study Team Lead to support effective study execution and delivery.
* Ensure that study conduct and clinical decisions are scientifically rigorous, clinically appropriate, and aligned with the clinical development plan.
* Provide medical input into study strategy, protocol implementation, operational decisions, and risk-mitigation plans.
* Identify emerging clinical or scientific issues and bring forward clear, evidence-based recommendations.
* Represent Clinical Development in study-team and cross-functional discussions.
* Escalate material clinical, safety, quality, or operational risks to program leadership and appropriate governance bodies###
** Medical Monitoring and Patient Safety
*** Serve as the Medical Monitor for the assigned clinical trial.
* Conduct medical monitoring activities, including eligibility consultation, medical review of participant data, protocol deviation assessment, and ongoing safety surveillance.
* Provide timely medical guidance to investigators, study teams, and clinical operations colleagues.
* Review and interpret adverse events, laboratory abnormalities, dose modifications, treatment interruptions, and other clinically significant findings.
* Partner with Safety to evaluate emerging safety signals and support benefit-risk assessments.
* Contribute to the development and implementation of appropriate safety-monitoring and risk-mitigation measures.
* Support aggregate safety reviews, safety governance discussions, and interactions with independent data-monitoring committees, as applicable.###
** Clinical Data Review and Interpretation
*** Collaborate with the Clinical Scientist, Biostatistics, Programming, Safety, and other team members to establish and execute clinical data-review plans.
* Review and interpret efficacy, safety, patient-reported outcome, imaging, and other relevant clinical data.
* Identify clinically meaningful trends, data-quality issues, inconsistencies, and areas requiring further analysis.
* Provide medical interpretation of study results and communicate their implications to cross-functional stakeholders.
* Contribute to data-cut planning, interim analyses, database-lock readiness, and final study analyses.
* Support scientifically and regulatorily defensible interpretation of primary, secondary, and exploratory endpoints.###
** Clinical and Regulatory Documents
*** Lead or contribute to the development, review, and maintenance of:  + Clinical study protocols and amendments  + Investigator’s Brochures …