Associate Medical Director- Oncology ,Sponsor-Dedicated (m/w/d) (23)

Study Physician

The Study Physician is a critical global role responsible for assuming medical oversight of clinical trials within Clinical Development & Operations. This position requires a qualified and clinically experienced physician who will provide comprehensive medical expertise throughout all phases of the trial—from preparation and conduct to reporting. The Study Physician ensures state-of-the-art medical oversight from the Trial Design Outline (TDO) kickoff through to the Clinical Trial Report (CTR) and serves as a core member of both the Trial Team and the Evidence Network Team.

Study Physician services

Medical Content Oversight

• Responsible for medical content in Clinical Trial Protocols (CTPs).
• Collaborates with Project Management, Patient Safety, Medical Writers, and trial/evidence teams.
• Provides medical input for CTP updates.

Risk-Based Quality Management

• Defines medically critical data/processes and associated risks.
• Contributes to Integrated Quality and Risk Management Plan (IQRMP).
• Participates in risk discussions during trial conduct.

Clinical Quality Monitoring

• Co-authors Clinical Quality Monitoring Plan (CQMP).
• Aligns CQMP with IQRMP-identified risks and mitigations.

Protocol Deviations Management

• Provides medical input on important protocol deviations (iPDs).
• Reviews and supports decisions on iPDs using advanced systems.

Clinical Quality Communication

• Proactively addresses and communicates clinical quality issues.

Trial Documentation and Milestones

• Contributes to timely preparation of core trial documents and milestones.

Data Management Input

• Designs eCRFs and translates medical questions into electronic data capture.
• Develops Information for CRF Completion (ICC) and Data Review Plans.
• Specifies lab parameters and contributes to Data Transfer Agreements and alerts.

Patient-Facing and Trial-Level Documents

Responsible for medical content in Patient Information and Informed Consent, Trial Monitoring Manual, Communication and Training Plans and Trial Statistical Analysis Plan (TSAP)

Reporting and Narratives

• Contributes to Patient Narrative preparation.
• Participates in planning and reviewing medical sections of Clinical Trial Reports.

Qualifications

• Medical degree from an accredited and internationally recognized medical school.
• Typically requires a minimum of 5-7 years' experience in clinical medicine.
• Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.