Clinical Development Medical Director, GU

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
• •Informed-consent documents
• •Medical-monitoring plans
• •Clinical Study Reports
• •Integrated clinical and safety summaries
• •Regulatory briefing documents
• •Health-authority questions and responses
• •Risk-management and safety-communication materials
• •Publications and scientific presentations

• •Ensure that clinical interpretations and conclusions are accurate, balanced, internally consistent, and supported by available evidence.
• •Collaborate closely with Medical Writing, Regulatory Affairs, Safety, Biostatistics, and other functions to deliver high-quality documents according to program timelines.

Regulatory and Governance Support

• •Provide clinical and medical input into global regulatory strategy for the assigned study.
• •Support preparation for and participation in health-authority interactions.
• •Present study status, emerging data, clinical risks, and recommendations to internal governance bodies, as appropriate.
• •Clearly communicate areas of uncertainty and provide balanced recommendations for decision-making.
• •Support inspection readiness and provide clinical rationale and documentation for key study decisions.
• •Ensure that important decisions and deviations from planned approaches are appropriately documented.

Investigator and External Engagement

• •Lead peer-to-peer medical interactions with investigators.
• •Serve as a point of contact for clinical questions involving the study team, investigators, steering committees, ethics committees, and regulatory authorities.
• •Participate in investigator meetings, advisory boards, scientific congresses, and other external engagements.
• •Develop trusted relationships with investigators and external experts while maintaining appropriate scientific and compliance standards.
• •Maintain current knowledge of prostate cancer treatment, clinical practice, relevant literature, evolving standards of care, and the competitive development landscape.

Cross-Functional Collaboration

• •Work closely with:
• •Clinical Scientists
• •Clinical Operations
• •Biostatistics and Programming
• •Pharmacovigilance and Safety
• •Regulatory Affairs
• •Clinical Pharmacology
• •Translational Oncology
• •Medical Writing
• •Data Management
• •Health Technology Assessment and Evidence colleagues
• •Medical Affairs

• •Build alignment across functions while maintaining an independent medical and scientific perspective.
• •Contribute constructively to program-level discussions, planning activities, and risk assessments.
• •Promote consistent clinical approaches across studies when scientifically and operationally appropriate.
• •Support and mentor Clinical Scientists and other study-team colleagues.

Basic Qualifications

As medically qualified individual, the successful candidate must have the following qualifications:

• •Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university and has 4+ years of experience.
• •Been licensed by a licensing body/health authority to prescribe medicines independent of Supervision for at least 2 years post their intern/house officer/foundation period.

• •Clinical training and meaningful patient-care experience in oncology.
• •Clinical research or drug-development experience in the pharmaceutical industry, biotechnology industry, academia, or a comparable environment.
• •Working knowledge of clinical trial design, conduct, analysis, and interpretation.
• •Understanding of Good Clinical Practice and applicable ethical and regulatory requirements.
• •Ability to interpret complex clinical and safety data and translate findings into clear medical recommendations.
• •Strong written and verbal communication skills.
• •Demonstrated ability to collaborate and influence in a cross-functional matrix environment.

Preferred Qualifications

• •2+ years experience in industry.
• •Board eligibility or board certification in Medical Oncology, Hematology/Oncology, Urology, or another relevant specialty preferred
• •Prostate cancer clinical or drug-development experience.
• •Experience supporting Phase 3 or registration-enabling oncology trials.
• •Prior experience serving as a study Medical Monitor.
• •Experience evaluating oncology efficacy endpoints and imaging-based assessments.
• •Experience working with blinded inde