Responsibilities

• Provide clinical and medical input (e.g., regarding unmet needs, translatability into patients or feasibility) at any stage during the R&D-value chain.
• Responsible for the translation of research projects into clinical trials to prove the value of projects.
• Development of the clinical part of the project development plan for a compound.
• Development of clinical trial protocols and provision of clinical input in the conception of CRFs (paper or electronic).
• Creation of the trial reports, critical review and quality checks of the clinical data.
• Development of the clinical part of the investigator brochure, specifically the risk benefit section, information to the investigators and reference safety information.
• Clinical trials: Responsible for medical monitoring, medical input, online follow up of patient data, AEs and SAEs follow up, narratives, participation in the preparation of statistical analysis plan and tables, figures, and listings.
• Interaction with investigators, coordinating investigator and the key experts, e.g., investigator meeting presentations, monitors training, regular contacts with investigators and experts. Establishment of and working with DSMBs.
• Overall supervision of the trial conduct in close working collaboration with the Clinical Trial Manager.
• Development of the clinical part of regulatory documents, e.g., briefing books, summary documents, answer questions to authorities.

• MD degree and holds a license to practice medicine.
• At least 5 years proven experience in running clinical trials specifically Phase II and Phase III trials in the pharmaceutical industry or with international CROs.
• Good understanding of the pharmaceutical value chain and experience in clinical development.
• Experience in running anti-infective clinical trials would be preferred.
• Experience in the translation of research projects into clinical trials ideally in the anti-infective or related indication fields.
• Previous experience in working as a treating physician in a hospital setting.
• Ability and experience in working as a team, e.g., in-house, with CROs, experts and opinion leaders.
• Openness and respect for diversity.
• Leadership, interpersonal communication, organizational and presentation skills.
• Results oriented, capable of setting priorities and managing high workload at times.
• Small biotech mentality and flexibility to accept and perform the tasks of his/her direct reporting workers and colleagues across projects in case of need.
• Fluent in business English, and speaking in German would be beneficial.

• Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration as well as trustful collaboration.
• Development: We encourage people to grow and strongly support individual development and learning opportunities.
• Flexibility: Embracing flexible working accommodations we enable our people to integrate business into their personal life.
• Benefits: Employer-funded pension comes along with an attractive benefits package

AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.