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Lead Clinical Program Manager
vor 3 Monaten
Position Title: Senior Clinical Program Lead - Oncology
Key Responsibilities:
- Act as the representative for Medicine within the International Multidisciplinary Evidence Teams, overseeing clinical development for assigned projects. This includes defining Target Product Profiles, Asset Evidence Plans, Pediatric Investigational Plans, and core Clinical Trial Protocols, as well as contributing to Project Analysis and Data Management Plans, Investigator Brochures, and Annual Safety Reports.
- Provide medical oversight throughout the clinical trial program, ensuring rigorous protocol development, execution, analysis, and reporting, while continuously assessing benefit-risk ratios. Manage medical project budgets for assigned projects.
- Utilize your expertise to facilitate interactions with external experts, advisory boards, adjudication committees, and Safety Data Monitoring boards.
- Deliver medical leadership during regulatory meetings and contribute to submission strategies, regulatory documentation, and safety assessments.
- Identify necessary studies and provide insights for Medical Affairs strategy documents, including Scientific Platforms, Publication Plans, and Product Maintenance Summaries.
- Review and approve project-related publications in collaboration with the Associate Head of Medicine.
As a Senior Clinical Program Lead, you will:
- Author key documents such as Investigator’s Brochures, Asset Evidence Plans, Core Clinical Trial Protocols, and Pediatric Development Plans in collaboration with cross-functional project teams.
- Mentor a team of Clinical Program Leads and contribute to Project Analysis & Data Management Plans, Company Core Data Sheets, and Annual Safety Reports.
- Provide medical leadership in regulatory discussions and support submission strategies and safety documentation.
- Maintain an external perspective to ensure a comprehensive understanding of relevant customer groups for your designated assets, including Health Authorities, Key External Experts, Associations, and Patient groups.
- Oversee and facilitate all interactions with external experts, executive committees, adjudication committees, and Safety Data Monitoring boards for your projects.
Qualifications:
- MD (Oncology specialist or equivalent) with substantial clinical oncology experience and ideally several years in the pharmaceutical sector.
- Proven success in planning, conducting, and publishing Basic Science and/or Clinical Research.
- Demonstrated medical and scientific leadership to drive high-priority projects in collaboration with global matrix teams, regional counterparts, and external partners.
- Previous engagement with regulatory authorities, international societies, and other relevant stakeholders.
- Strong communication and presentation skills.
- Excellent collaboration abilities and experience working in virtual teams.
- Fluency in English.
The Senior Clinical Program Lead role also requires:
- MD (Oncology specialist or equivalent) with extensive clinical oncology experience and multiple years in the pharmaceutical industry.
- In-depth clinical development experience along with several years in an international role within the Pharmaceutical Industry, with prior responsibility for international clinical development projects.
