Clinical Development, Associate Director Innovative

vor 11 Stunden


Home Office, Schweiz Hengrui Europe Therapeutics AG Vollzeit

**Job Title**: Clinical Development Associate Director Innovative Medicines

**Reports to**: Sr. Medical Director for Innovative Medicines

**Department**: Innovative Medicines, Clinical Development

**Location**: Basel, Switzerland OR Spain, OR Poland OR Netherlands

**Direct reports**: No

Responsible for the management of assigned trials from clinical for investigational and/or marketed products in the Innovative Medicines Therapeutic Area (TA). The incumbent will support the Medical lead in development strategy for assets, draft development plans, protocols, and clinical sections of submission documents under guidance of Medical lead. Represents Clinical Development on Study Teams and collaborates with other functions to drive the execution of the clinical development plans. assigned trials from clinical for investigational and/or marketed products in the Innovative Medicines Therapeutic Area (TA). The incumbent will support Medical lead in development strategy for assets, draft development plans, protocols, and clinical sections of submission documents under guidance of Medical lead. Represents Clinical Development on Study Teams and collaborates with other functions to drive the execution of the clinical development plans.

Our parent company Jiangsu Hengrui Medicine (600276 SHA) is a global pharmaceutical company with around $90 Billion market value, $3.6 Billion annual revenue (data by 2019) and over 30,000 employees globally. Our pipeline opportunities include antineoplastic, metabolic, cardiac, surgical, contrast agents, anti-virals, and antibiotics. The therapeutic areas are diverse, covering oncology, autoimmune, pain management, neuroscience, metabolics, etc.

We recognize, appreciate, and reward our team’s contributions; we emphasize our people’s well-being. We want our employees to feel empowered to do their best work, to engage in shaping our growing ex-China organization and to be part of a team where they are respected, engaged, fulfilled, and developing

**Job Summary**:
Responsible for the management of assigned trials from clinical for investigational and/or marketed products in the Innovative Medicines Therapeutic Area (TA). The incumbent will support the Medical lead in the development strategy for assets, draft development plans, protocols, and clinical sections of submission documents under the guidance of the Medical lead. Represents Clinical Development on Study Teams and collaborates with other functions to drive the execution of the clinical development plans.

Tasks

**Essential Job Functions**:
Medical Monitoring
- Contributes to and is a key member of a high performing Study Delivery Team (SDT) and be a member of the Clinical Development Team (CDT)
- Supports Medical Lead in data review of trial data, including eligibility review
- Holds responsibility for site interactions for medical questions and education (including safety management guidelines)
- Support medical lead in ensuring safety of the compound for the assigned trials and in the analysis of benefit/risk for clinical development protocols in partnership with Worldwide Patient Safety and oversees safety narratives
- Supports Medical lead in drafting clinical development plans. Contributes along with Medical lead to the development of study design to meet study objectives. Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training

Clinical Development Expertise & Strategy
- Collaborate closely with relevant functions within Hengrui Group, including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, as well as personnel from Global Clinical Operations, Global Strategic Marketing, and other support functions.
- In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
- Supports the analysis of benefit/risk for clinical development protocols in a matrix team environment
- Partners with Study Lead to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
- Identifies and builds relationships with principal investigators, key opinion leaders in drug development. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
- Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the



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