Following continued growth, Apsida Life Science are working in parallel with a key client supporting their clinical development pipeline. Exclusively, we have been tasked to assist in the search for an Associate Director Clinical Scientist to be based in the Geneva area.
The Associate Director Clinical Scientist (ADCS) will contribute to the clinical development of our clients compounds and assume a leadership role in overseeing the design, the compliant execution, and the evaluation of oncology clinical trials to ensure data quality and integrity. The individual may likely be involved across the different compounds of our clients portfolio as well as across different developmental stages these compounds have reached. The successful candidate will partner with Physician(s) in the Clinical Development Group and in close collaboration with other functions across the group.
Medical group level responsibilities:
- Work in partnership with other Clinical Scientists (CS), including the Head of CS, to harmonize processes, which include, but is not limited to, guidelines, documents templates.
- Identify & escalate current and potential issues; propose solutions and follow until resolution.
- Author and/or review clinical research standard operating procedures (SOPs).
Project level responsibilities (as applicable):
- Work in partnership with other functions in compound development.
- Engage external stakeholders to support compound development; this includes, but not
limited to, Investigators, Key opinion leaders, external researchers, consultants
- Assist in writing annual reports, integrated medical reports, responses to regulatory authorities,
investigator brochure, and other documents requiring data summarization.
- Contribute to pharmacovigilance data review and analysis, including participation in safety review team meetings
- Contribute to the preparation and may participate in scientific advisory boards; prepare and present clinical data at external meetings
- Support the clinical program leaders regarding ad-hoc requests from upper management
- Develop and maintain knowledge in order to effectively understand and communicate information relating to the company’s investigational products and therapeutic areas, including competitor landscape
Study level responsibilities:
- Lead/contribute to the development and maintenance of core study documents (protocol,
master informed consent form, clinical study report, etc.)
- Support study committees (e.g., data monitoring committee, dose-escalation steering
committee) activities (e.g., charters, meetings, presentations) as applicable
- Develop and/or conduct training for study protocols, e.g. on disease area or therapeutic
- Collaborate with Clinical Operations to identify, engage, and train potential investigators,
including participation in study site visits as needed (this includes the contribution to the
- Contribute to the development of study-related documents for submissions to Institutional
Review Board(s)/Ethics Committee(s) and regulatory authoritie(s); and to address any of their
study-related questions, as applicable
- Serve as primary clinical liaison with other functions to ensure CRFs and other associated
documents (e.g., edit check plan, medical data review plan, etc.) are appropriately designed and
actively participate in clinical data review meetings
- Review/develop data review plans, statistical analysis plans, data output formats, etc.
- Initiate and perform data review and cleaning (i.e., identify and query data discrepancies, incl.
follow up of key findings) on an ongoing basis, including data from vendors, AE/SAE
- Provide scientific oversight of vendors as applicable
- Contribute to study publications, as per assignation
If you’re interested, reach out to Jamie Salmon to find out more!