The new recruit will be responsible for the phase 3b/4 clinical trials evaluating the use of iglarlixi in patients insufficiently treated with oral hypoglycemia agents
Iglarlixi can be positioned as either the first injectable (when oral hypoglycemic agents are insufficient) or as intensification when basal insulin or GLP-1 do not achieve the desired treatment goal. The first strategy covers the largest and most diverse group of patients (approximately 1.4 mio patients in the US alone).
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He/she will be responsible for developing and overseeing the late phase clinical program to demonstrate and further support the value of iglarlixi in this indication.
In addition to the phase 3b/4 program, this position will be responsible for the medical communication and education activities that will support the appropriate use of iglarlixi in this indication, in close collaboration with Scientific Communication and Medical Education and the development and maintenance of relations with KOLs who can advice on the clinical use of iglarlixi.
The new recruit will have a good understanding of the regulatory, compliance and legal frame work.
Main missions
Identify the need for additional clinical data to appropriately support the clinical use of iglarlixi and evidence that will support patient access to the drug globally.
Develop a phase 3b/4 clinical research program that will provide solid scientific data in support of the product, in collaboration with R&D as appropriate.
Design and execute the clinical program within agreed time and budget framework, in close collaboration with internal and external partners.
Ensure appropriate analysis and publication of data from the program
Identify data analysis from existing data that can support the indication.
Identify and interact with external expertise to ensure the highest scientific standards and clinical relevance of the program.
Provide medical support to global and local partners within the company to obtain regulatory approval and market access
Other Responsibilities
Clinical responsible for evaluation and support for Investigator Sponsored Studies related to lizisenatide and iglarlixi
Management responsibilities
No direct management
Matrix-based interaction with clinical and regulatory leads in affiliate countries and regions
Team interaction with Data Analytics, Scientific Communication, External Relations and regional and local medical directors.
Resources
Responsible for the clinical budget in support of the indication
Autonomy
High degree of autonomy and pro-active management of projects and studies
Reports to Global Medical Lead, Iglarlixi and lisisenatide
Internal and external key Interfaces
The clinical operation platform
KTL and Scientific Communication Group
The country clinical lead for the product
The marketing counterpart
The KOLs community
The Value & Access team
Data Analytics lead
Qualifications
Educational background
Scientific medical degree (MD); Documented knowledge of diabetes;
Previous experience with clinical trial design and execution in diabetes;
Language skills
English (multilingual is a plus)
German or French might be advantageous
Experiences and specific knowledge
Strong of experience (>5 years) in Pharma business
Understanding of clinical needs in diabetes
Knowledge of the KOLs in Diabetes
Understanding of compliance and legal requirements
Knowledge of the regulatory landscape
Professional competencies
- Strategic thinking and prioritizing capacity
- Business and customer oriented
- Analytic and synthetic capacity
- Ability to understand and simplify scientific concepts
- Innovation/Creativity
Behavioural competencies
- Ability to work in an international matrix organization
- Interpersonal/communication skills ability to address the scientific and non-scientific community as a target group
- Team spirit and teamwork ability
- Adaptable and flexible
- Willing to travel to support the active pre-launch phase
Rationale for external recruitment
The selected candidate in addition to having all of the skills mentioned above, needs to have the profile of an experienced physician and/or scientist with a record of pharma experience. Critical know how of diabetes clinical needs are important elements to maximize success on the job.

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