Associate Director, Clinical Research

Role Summary

The Clinical Scientist is a dynamic role for a highly motivated individual to contribute to the design, development, and execution of clinical strategies for I-Mab’s Immuno-Oncology programs. This individual will play a key role in shaping the clinical direction of I-Mab’s pipeline, providing both strategic and scientific input to ensure the success of clinical trials.

In close collaboration with the Oncology Medical Lead and cross-functional teams, this role will assist in the design, implementation, and management of clinical research projects. This will include developing and reviewing clinical documents such as protocols, informed consent forms, and Investigator Brochures, while ensuring adherence to regulatory standards and clinical objectives. Additionally, this role will evaluate and analyze clinical data to support informed decision-making and project advancement.

The role will also support the Senior Medical Director by providing day-to-day clinical trial management and contributing to strategic clinical development initiatives.

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 (i.e., 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
• Other duties as assigned

Qualifications

• DNP, PharmD or PhD with clinical research experience and a strong knowledge of drug development, or equivalent required
• At least 3 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
• Experience with RECIST for tumor assessment highly desired
• Experience with CTCAE for adverse events assessment/grading highly desired

Skills

• 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 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
• Other duties as assigned

Education

Additional Requirements

• Ability travel domestically/globally at relevant oncology medical meetings/conferences (i.e., ASCO, SITC, ASH, etc.) up to 15 - 20% of the time
• Authorized to work in the United States without Visa sponsorship

Work Environment & Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Occasional standing, walking, and reaching within the office environment
• Ability to lift up to 15 pounds at times
• Ability to perform essential job functions with or without reasonable accommodation