Associate Director, Clinical Research and Trials

1 week ago

Sydney, Australia BeiGene Full time

**Job Description**:
Company Overview:

- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 10,000 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland, Australia and Brazil, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients

General Description:

- Critical member of a highly innovative and entrepreneurial team driving solutions to clinical trial inefficiencies, rising costs of drug development, lack of utility of technological advances in healthcare/pharma tech, and fragmented data silos. The Applied Innovation team will innovate and incubate technological solutions to ultimately increase patient access to clinical trials and novel therapeutics. The team will also drive the creation of novel methodologies to capture, house, integrate, and analyze data from disparate sources to drive strategies towards effective personalized medicines of high value. Ultimately, the vision of Applied Innovation is to drive value creation through the development of novel technologies and focused data analytics. The Associate Director, Clinical Research Lead will be expected to lead Clinical Trial Operations in Brazil and represent Applied Innovations at the country level. The incumbent will work closely with site staff on setting up clinical research infrastructure at the sites that will run clinical trials. The Associate Director, Clinical Research Lead is responsible for providing expertise on development and implementation of FICS at Clinical Trial Sites. The incumbent will work directly with other members of the Applied Innovation team and be accountable for creation and enabling policies and procedures, novel technology infrastructure, and designing methods for delivery of novel technology at clinical sites. This role will also have global project management and Clinical Operations responsibilities. The incumbent will have a diverse background working with Sponsors, CROs, and Clinical sites and utilize past experiences and knowledge to work in a fast past creative environment with a focus on optimizing current practices in Clinical Research.

Essential Functions:

- Provide operational expertise on Sponsor and Site interface of FICS
- Provision of expert knowledge on clinical trial compliance with local and global regulations
- Support Applied Innovations and vendors with implementation of novel technology
- Participate in problem solving discussions with internal and external stakeholders
- Train Applied Innovations team members and other stakeholders within the organization and work closely with Clinical Transformation Lead to develop training program and tools
- Identify pain points in major workflows by contributing to development of wireframes/templates and tools to address these challenges
- Surface suggestions on improvements in software and processes
- Assist with development of novel technology (FICS), data capture forms and instructions
- Clinical Research Associate experience
- Mastery of Project Management with an ability to lead cross functional working groups and teams
- Hands-on experience of managing project and study budgets
- Proven matrix leadership to accomplish team and organizational objectives
- Significant understanding of the overall drug development and commercialization process
- In-depth work experience of Ph1-3 Oncology development process
- Full grasp of the latest research and thinking
- Solid knowledge competitive landscape and activities
- Demonstrated ability to shape and deliver business cases
- Excellent written and verbal communication skills as well as proven negotiation, collaboration, and interpersonal leadership skills
- Experience of leading a development team and working in a global environment
- Willingness to travel both domestically and internationally
- Conceptual, analytical, and strategic thinking
- Ability to influence strategically across all levels of the organization
- Expert with clinical operations systems such as EDC, RTSM, CTMS, and eTMF
- Professional understanding of different core functions within the Clinical Trial ecosystem ie. Clinical Operations, Clinical Development, Data Management, and Biostats
- Develop, create, and track SOPs, Policies, and Procedures
- Other tasks delegated as needed

Qualification Required:
Minimum Requirements - Education and Experience:

- Bachelors Degree and a minimum of 8 years experience in Oncology Clinical Trials or Masters Degree and a minimum of 6 years experience in Oncology Clinical Trials

Other Qualifications:

- Effective problem and conflict resolution skills and proven team focus
- Excellent knowledg

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