The ArriVent Clinical Development organization is responsible for developing and executing early and late development clinical strategies and plans to deliver medically-differentiated therapies that provide meaningful improvement to patients. This role provides an exciting opportunity to participate in the future expansion of ArriVent Biopharma, Inc. Working in collaboration with the Clinical Development (CD) team this role is responsible for various aspects of ongoing clinical trial program-related activities. These activities encompass, but are not limited to, collaboration on functional area activities during program implementation, clinical study startup/execution/close out, data analysis/reporting and support of HA interactions.
Essential Duties and Job Functions:
- Manages the preparation of study protocols, amendments, informed consents, charters, specific sections of study manuals, and other documents as needed with appropriate guidance and supervision.
- Manages start up activities, including but not limited to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
- Addresses questions regarding scientific and related procedural issues from internal and external parties regarding assigned studies and programs
- Manages the preparation and/or review of data listings, summary tables, study results, manuscripts, scientific presentations, as well study close-out activities
- Prepares and reviews regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs
- Supports priorities within functional area
- Plays a lead role in the development and implementation of communications strategies to support existing and concluded studies
- Is able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development
- Completes and/or leads other special projects, as and when assigned, or otherwise requested
- Consistently complies with all governing laws, regulations, ArriVent Standard Operating Procedures (SOPs) and other guidelines
Knowledge, Experience and Skills:
- Typically requires an advanced degree such as PharmD or PhD in clinical research or clinical pharmacology
- 3+ years of relevant scientific and/or drug development experience in a pharmaceutical company, contract research organization or academic institution
- Able to work in a fast-paced dynamic organization
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed
- Possesses excellent verbal and written communication skills as well as interpersonal skills to maintain working relationship with team members to ensure scientific integrity of clinical studies
- Strong presentation skills: highly effective at summarizing and presenting the key considerations and decision-points
- Confident and competent when interacting with varying levels of internal/external management, key opinion leaders, etc., stays focused and on-point, and can raise problems or challenges in a productive and mature manner
- Experienced with Microsoft Office (Word, Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire, MediData Rave, etc.