Lead Clinical Program Manager
vor 4 Wochen
Position Title: Senior Clinical Program Lead - Oncology
Key Responsibilities:
- As a pivotal member of the team, you will represent the Medical department at the International Multidisciplinary Evidence Teams, taking charge of 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.
- You will ensure medical oversight throughout the clinical trial program, from protocol development to analysis and reporting, maintaining a continuous assessment of benefit-risk ratios. Additionally, you will manage medical project budgets associated with your projects.
- Your extensive expertise will facilitate connections with external experts, advisory boards, adjudication committees, and Safety Data Monitoring boards.
- In this role, you will provide medical leadership during regulatory meetings and contribute to the development of submission strategies, regulatory dossiers, and safety considerations.
- You will proactively identify necessary studies and contribute to Medical Affairs strategy documents, including Scientific Platforms, Publication Plans, and Product Maintenance summaries.
- Furthermore, you will review and approve publications related to your projects in collaboration with the Associate Head of Medicine.
As a Senior Clinical Program Lead, you will:
- Author essential 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 while providing input on Project Analysis & Data Management Plans, Company Core Data Sheets, and Annual Safety Reports.
- Utilize your expertise to lead medical discussions in regulatory meetings and support submission strategies and safety issues.
- Maintain an external focus 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 industry.
- A proven track record 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.
- Experience with regulatory authorities, international societies, and other relevant international stakeholders.
- Strong communication and presentation skills.
- Excellent cross-functional collaboration abilities and capacity to work within virtual teams.
- Fluency in the English language.
Additional Requirements:
- MD (Oncology specialist or equivalent) with extensive clinical oncology experience and multiple years in the pharmaceutical industry.
- Profound clinical development experience along with multiple years in an international role within the Pharmaceutical Industry, with prior responsibility for international clinical development projects.
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Deutschland Pharmiweb VollzeitPosition Title: Senior Clinical Program Lead - OncologyKey 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...
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