- Lead and/or contribute to multiple phase I/IIa studies, ensuring study deliverables are met on time, on budget, and with the appropriate quality
- Contribute to selection of, negotiation with, and supervision of CROs
- Write and/or organize the writing and/or review of study-related documents. Work in close collaboration with the Clinical Pharmacology Modeling and Simulation group to include the appropriate related components in the study protocol. Contribute to the writing of the clinical sections of regulatory documents
- Contribute to the preparation of submission documents to IRB/IEC and health authorities and answer all scientific/medical inquiries from IRB/IEC and/or health authorities
- Develop a comprehensive understanding of the science related to a study and/or project and provide appropriate training in the medical/scientific aspects of the study to the appropriate persons
- In collaboration with operational staff manage monitoring aspects of the study including but not limited to initiation visit, first dosing, and database lock activities.
- Responsible for the medical review of study data prior to database lock
- Responsible for all aspects of study protocols, reports, project summaries, and development plans regarding regulatory requirements
- Interpret and present study results to Life Cycle Team, Development Team, and committees comprising members of company’s Senior Leadership
- Perform literature reviews and write scientific publications when required
- Provide expertise to the PK/PD section of protocol of phase llb-IV studies
- Follow relevant quality control procedures to verify that the quality requirements for the trial-related activities are fulfilled
Qualifications and Experience:
- A minimum master’s degree level of education in a relevant scientific subject with a preference for PhD or MD level of education.
- At least 2 years’ clinical research experience, leading or contributing to the scientific aspects of Phase I/IIa clinical trials within a pharmaceutical, biotech or CRO organization.
- We have a strong preference for candidates who can demonstrate recent authorship or contribution to scientific publications.
- Experience with pharmacokinetic (PK)/pharmacodynamic (PD) evaluation techniques.
- Ability to handle and oversee multiple tasks simultaneously and to prioritize in a high-pace environment.
- Excellent organizational ability and flexibility with a keen attention to details.
- Highly self-motivated and proactive with a scientific and pragmatic approach to problem solving.
- A team-player with well-developed interpersonal and communication skills; able to communicate effectively with internal and external contact persons in complex matrix organizations.
- Very good English knowledge (oral/written).
- Relevant working/residency permit or Swiss/EU-Citizenship required