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Lead Clinical Program Manager
vor 2 Monaten
Position Title: Senior Clinical Program Lead - Oncology
Key Responsibilities:
- In this capacity, you will serve as the representative for Medicine within the International Multidisciplinary Evidence Teams, taking charge of clinical development for assigned projects. This includes defining Target Product Profiles, creating Asset Evidence Plans, and developing core Clinical Trial Protocols.
- You will oversee the medical aspects of the clinical trial program throughout its lifecycle, ensuring continuous benefit-risk assessment and managing project budgets effectively.
- Your extensive expertise will facilitate connections with external experts, advisory boards, and Safety Data Monitoring boards.
- Additionally, you will provide medical leadership during regulatory meetings and contribute to the formulation of submission strategies and regulatory documents.
- You will proactively identify necessary studies and contribute to Medical Affairs strategy documents, including Scientific Platforms and Publication Plans.
- Furthermore, you will review and approve project-related publications in collaboration with the Associate Head of Medicine.
As a Senior Clinical Program Lead, you will:
- Author essential documents such as Investigator’s Brochures and Pediatric Development Plans alongside cross-functional project teams.
- Mentor a team of Clinical Program Leads while providing input on Project Analysis and Data Management Plans.
- Utilize your expertise to lead medical discussions in regulatory meetings and support submission strategies.
- Maintain an external perspective to ensure a comprehensive understanding of relevant customer groups, including Health Authorities and Patient groups.
- Oversee all interactions with external experts and committees related to 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, executing, and publishing Basic Science and/or Clinical Research.
- Demonstrated medical and scientific leadership to drive high-priority projects in collaboration with global teams and external partners.
- Prior experience with regulatory authorities and international stakeholders.
- Strong communication and presentation skills.
- Excellent collaboration skills and ability to work effectively in virtual teams.
- Fluency in English.
Additional Requirements:
- 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 previous responsibility for international clinical development projects.
