Associate Director Clinical Development Innovative

Vor 2 Tagen

Basel, Schweiz Hengrui USA Vollzeit

**Reports to (Title)**:Sr. Medical Director for Innovative Medicines**
**Location: Europe**
**Exempt/Non-Exempt: Exempt**
**Direct Reports : No**
**Department**:Innovatives Medicines, Clinical Development**

The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative medicines portfolio for the US, Europe and Japan. Our ex-China team drives strategy and operational implementation for clinical development, regulatory approval and commercial success.
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. In Europe, Hengrui has its main hubs in Switzerland, Spain, Netherlands and Poland.
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 for 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..

**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 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 disease area by attending scientific conferences and ongoing review of the literature
- Develop site and CRA protocol training materials and present these at SIVs and Investigator meetings
- Work closely with Data management to develop Data Review Plan and ensure CRF design adequately supports data collection in alignment with the protocol
- Support Medical Lead in interactions with internal and external stakeholders and boards
- Provide European perspective into Global projects and coordinate activities among Chinese, European and US medical teams.
Health Authority Interactions & Publications
- Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submissi

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