I-Mab (Nasdaq: IMAB) is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal discovery and global partnerships for in-licensing, based on the Company's Fast-to-Proof-of-Concept and Fast-to-Market development strategies. The Company is progressing from a clinical stage biotech company into a fully integrated global biopharmaceutical company with cutting-edge R&D capabilities, a world-class GMP manufacturing facility and commercial capability. I-Mab has offices in Beijing, Shanghai, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.

Under the I-Mab US office, through extensive interaction with the Oncology Medical Lead and the rest of the clinical development team, this individual will have an opportunity to make an impact through strategic and scientific input for I-Mab’s clinical programs. This role collaborates with the Oncology Medical Lead and across multi-functional teams to assist with the design, plan, and implement the overall direction of clinical research projects (primarily Phase 1-2). The tasks involved includes but not limited to writing protocols, protocol amendments, informed consent documents, and Investigator’s Brochures. This individual will also coordinate activities to ensure compliance with protocol and overall clinical objectives as well as evaluate and analyse clinical data.

Responsibilities:

Assist the Clinical Lead and/or Study Director in the planning and implementation, execution, day-to-day managing and reporting of clinical trial program(s)
Assist with the preparation of the clinical trial synopses, protocols, protocol amendments, drug development plans, clinical research forms, Investigator Brochure, Clinical Study Report, pharmacy manuals etc.
Collaborate with clinical operations to develop and implement the overall data quality plan
Develop and provide input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications for review/discussion with Medical Director (ie. investigator meetings, safety review committee, pre-study site selection visits, communications to study sites, etc)
Attend Site Initiation Visits and provide site guidance for trials
Assist with competitive intelligence and/or other market/industry assessment projects for the development of clinical strategic plans within internal programs
Assist with the preparation of the NDA documents
Prepare clinical sections of IND annual safety report and annual Investigator Brochure updates
Assist with the database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.)
Assist with the preparation of the publications (abstracts, articles, etc.) pertinent to the study
As appropriate, interact with key opinion leaders (KOLs), PIs and external vendors, etc.
Build talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities

DNP, PharmD or PhD with clinical research experience and a strong knowledge of drug development, or equivalent strongly preferred
At least 3 - 5 years of technical operational experience in early phases of clinical trial planning, start up, conduct, reporting and publishing required
Experience in clinical oncology is required with recent immuno-oncology experience strongly preferred
Extensive direct knowledge of the clinical development process with the ability to understand concepts of various phases and principles of study design is required
Experience with interacting with medical monitors, development operations and clinical investigators
Thorough understanding of ICH, GCP, and relevant regulatory requirements is required.
A thorough understanding of clinical research methodology including study design, protocol writing and CRF preparation is required as is a knowledge of GCP and local regulatory requirements
Working knowledge of the IND/NDA process acquired through direct industrial experience is required
Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area.
The ability to work with cross-functional teams in a matrix environment is a must
Strong organizational and time management skills; meticulous and detailed oriented
Self-motivated and able to work with limited supervision
Excellent interpersonal and communication skills
Proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Office Timeline/Project.
Ability travel domestically/globally at relevant oncology medical meetings/conferences (ie. ASCO, SITC, ASH, etc) up to 15 - 20% of time

All your information will be kept confidential according to EEO guidelines.

I-Mab Biopharma remote jobs

Clinical Research Manager