Senior Clinical Trial Manager
ImmPACT Bio USA
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, developing novel cell therapies for treating cancer and autoimmune disease. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT Bio is seeking an innovative, highly-motivated, versatile leader to join us as a Sr. Clinical Trial Manager, Clinical Operations. The successful candidate will manage all aspects of the clinical trial(s) including study start-up, enrollment, study conduct, close-out and the clinical study report (CSR) process. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to the Senior Manager or Director of Clinical Operations.
NOTE: This position can be located onsite in West Hills, CA or remote/hybrid based on the candidate. The key is to ensure that there are strong communication channels with others on the study- and program- teams as well as building trustful relationship with those at ImmPACT and with key contract research organization (CRO) and clinical trial site stakeholders.
- Oversees all operational aspects of assigned clinical trial(s).
- Oversees the clinical trials including study start-up, enrollment, study conduct, close-out and the clinical study report (CSR) process.
- Prepares and reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
- Provides oversight and guidance if some tasks are delegated to a Clinical Trials Manager or Specialist.
- Participates in study strategy development, Line Listing Review, and Clinical Study Report preparation, as appropriate.
- Manages the study project plan, including timelines and budget.
- Provides training and manages CRO vendors such as IVRS, Central lab, Imaging.
- Works with CRO to develop and revise study specific plans and detailed timelines and ensure that transferred obligations and performance expectations are met.
- Further manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files). Creates and implements corrective action plan when performance expectations are not being met.
- Seamlessly coordinates internally and externally with multiple stakeholders when patients are identified, samples are collected and delivered for cell therapy clinical manufacturing and when product is prepared, released and delivered by to the clinical site for patient therapy.
- Proactively identifies potential study issues/risks and recommends/implements solutions.
- Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. Prepares metrics and updates for management, as assigned.
- Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
- Reviews site study documents (informed consent template and study tools/worksheets).
- Serves as a liaison and resource for investigational sites.
- Participates in the development, review and implementation of departmental SOPs and processes.
- Attends cross-functional meetings as needed to represent Clinical Operations and study-specific issues.
- Provides mentorship and career development to direct reports.
- Includes other duties and responsibilities as assigned. Duties and responsibilities may be modified or changed at any time based on the needs of the business.
- Bachelor of Science with ten (10) years of experience, or Master of Science with six (6) years of experience, or Ph.D. with three (3) years of experience or equivalent amount of education and experience
- At least 6 years of related oncology clinical trial management experience on the sponsor side.
- Highly competent knowledge of transplant patient care and apheresis collection a plus.
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
- Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management.
- Highly developed leadership skills to successfully lead a clinical study team.
- Must be willing to travel at least 25% (possibly more).
- Ability to deal with time demands, incomplete information or unexpected events.
- Must display strong analytical and problem-solving skills.
- Attention to detail and quality in documentation practices.
- Outstanding organizational skills with the ability to multi-task and prioritize.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Ability to be part of the team as well as step in to lead.
Compensation for the role will depend on several factors, including a candidate’s qualifications, skills, competencies, and experience.
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.