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Medical Manager – Global Clinical Development
We are currently hiring for an international specialty pharmaceutical organisation advancing innovative treatments. We are seeking a Medical Manager to provide scientific and medical leadership across clinical programs, ensuring high-quality study design, execution, and oversight.
Key Responsibilities
- Lead medical oversight for clinical studies, including protocol development and adherence to Quality-by-Design (QbD) principles.
- Act as medical monitor, conducting safety reviews, resolving medical queries, and ensuring compliance with study conduct.
- Support development of Case Report Forms (CRFs), Medical Monitoring Plans, and Clinical Study Reports.
- Maintain strong relationships with investigators and clinical sites.
- Provide medical input for pharmacovigilance activities across clinical and post-authorisation studies.
- Review clinical and safety data, identify risks, and propose mitigation strategies.
- Ensure inspection readiness and provide support for Good Clinical Practice (GCP) audits/inspections.
- Drive process improvements, digital trial initiatives, and cross-functional knowledge transfer.
- Deliver internal scientific training and represent the organisation at scientific meetings.
- Support communication with regulatory authorities as required.
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Requirements
-Must hold a Medical Degree (MD or equivalent). -Must have 4+ years of experience in clinical research or clinical development. -Strong knowledge of ICH/GCP guidelines and global clinical trial regulations. -Proven experience in medical monitoring, protocol development, and clinical data review. -Demonstrated excellent written and verbal communication skills. -Exceptional analytical, decision-making, and project leadership abilities. -Capability to work independently, manage deadlines, and resolve issues efficiently.
Benefits
- Competitive salary and benefits package.
- Opportunity to impact patient care and contribute to meaningful scientific progress.
- High exposure to senior scientific experts and strategic programs.
- Collaborative, intellectually driven environment focused on clinical excellence.
- Hybrid work model (3 days on-site).
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Desired Skills & Experience
Core Competencies:
- Medical Doctor (MD)
- Clinical Development
- Clinical Trial Management
- Medical Monitoring
- Protocol Development
- Quality by Design (QbD)
- Pharmacovigilance
- ICH/GCP Compliance
- Clinical Data Review
- Medical Affairs
Leadership & Operational:
- Cross-functional Leadership
- Investigator Engagement
- Clinical Site Management
- Risk Management
- Clinical Project Management
- Standard Operating Procedure (SOP) Development
- Scientific Communication
- Regulatory Interaction
- Inspection Readiness
- Audit Support
- Clinical Strategy
- Medical Governance
- Stakeholder Management
Soft Skills:
- Scientific Writing
- Problem Solving
- Time Management
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