Physician

• Lead proactive patient safety and benefit-risk strategy for assigned investigational compounds across early clinical development
• Provide medical safety leadership for first-in-human, dose-escalation, proof-of-concept and other clinical studies
• Review protocols, investigator brochures, safety monitoring plans and clinical study reports
• Integrate clinical, nonclinical, translational, epidemiologic and external evidence to identify, characterize and communicate emerging safety risks
• Partner with cross-functional development teams to define risk-management and risk-minimization measures
• Contribute to program governance, regulatory interactions and evidence-based go/no-go decisions
• Oversee ongoing safety surveillance, signal evaluation and aggregate safety assessment
• Provide medically sound input to regulatory documents, including DSURs, RMPs and submission safety sections
• Represent Experimental Medicine Patient Safety in internal and external forums
• Communicate the evolving safety profile to senior leaders and regulators
• Lead matrix teams or strategic safety initiatives as assigned

Senior Patient Safety Physician – Ophthalmology

• Provide medical information and guidance on the blood or plasma donation process
• Conduct comprehensive medical history assessments and physical examinations of donors
• Monitor the donation process, including stabilizing impaired vital functions
• Assess laboratory results
• Ensure compliance with quality assurance measures
• Provide medical supervision of the donation process at donation centers
• Participate in regular training and continuing education
• Respond quickly in the event of an emergency

Doctor (m/f/d)

• Provide readily available, high-quality medical support and consultancy for global clinical trials
• Contribute to discovery, development and delivery of innovative medicines while ensuring scientific and medical quality throughout trial planning and conduct
• Own the medical content of Clinical Trial Protocols and updates in line with the Trial Design Outline
• Collaborate with the CTL, CPL, Patient Safety Physician, Medical Writer and other trial and evidence team members
• Define medically relevant critical data and processes, assess risks, and establish mitigation and monitoring strategies in the Integrated Quality and Risk Management Plan
• Co-author the Clinical Quality Monitoring Plan and execute agile, adaptive monitoring using aggregated and near real-time data
• Proactively address quality issues and ensure timely mitigation and escalation
• Provide medical input into Data Management documentation, including eCRF design, CRF completion guidance, Data Review Plan, data checks, laboratory specifications, Data Transfer Agreements and central laboratory alerts
• Support the definition, review and assessment of important protocol deviations
• Own the medical content of patient information, informed consent materials, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan and Trial Statistical Analysis Plan
• Contribute to patient narratives, Clinical Trial Report planning and review, regulatory and Ethics Committee or IRB responses, trial newsletters and scientific publications
• Provide medical input into study and site feasibility, patient recruitment and retention plans
• Respond to medical queries from investigators, CROs and sponsor representatives and maintain the trial FAQ
• Build expert networks, contribute to site engagement and deliver medical training during country feasibility activities, investigator meetings and sponsor trainings
• Support Endpoint Adjudication, Data Monitoring Committees, Data Safety Monitoring Boards and Steering Committees by presenting study medical content and answering medical questions
• Help ensure high-quality data from a clinical quality monitoring perspective

Physician jobs in Germany

Senior Patient Safety Physician – Ophthalmology

Doctor (m/f/d)

Study Physician