The Global Clinical Leader - Immunology is responsible for clinical programs across indications, involving one or multiple compounds. In order to support decision milestones, regulatory requirements, market access, and ownership of the risk benefit assessment for the program, this job is responsible for the design, planning, and execution of a clinical development program. accountable specifically for the clinical development strategy and contributes to the immunology strategy.
As the Global Clinical Leader, you will be accountable for the following:
- Supervising clinical trials and speaking for clinical development on the global program team
- Supporting Business Development initiatives; serving as the Clinical Development Representative on teams to advance goals, including creating the Clinical Development Plan.
- Being in charge of the CDP's execution and making contributions to the IDP created by various line functions in order to successfully gain worldwide regulatory approval and market access for one or more therapeutic indications and/or programs.
- Supervising the development of clinical components for important documents that are of a high caliber and adhere to the CDP. supporting product license maintenance, market access, registration, and commercialization for the compound(s)
- Assisting as a key member of the Safety Management Team in ensuring ongoing examination of the drug safety profile, which includes safety monitoring of clinical studies and signal detection from post-marketing surveillance.
- Managing contacts with internal decision boards, internal stakeholders, and external stakeholders as the medical expert