Description

*This has been designated as a remote based role. However, please note that this position will need to observe Pacific hours. We can consider remote based employee in the following states:

California

Arizona

Florida

Massachusetts

Maryland

Michigan

Nevada

New Jersey

North Carolina

Pennsylvania

Texas

Washington 

Your Impact

Our Clinical Operations team is looking for a pro-active, collaborative, and enthusiastic clinical trial leader to join our tight-knit team. In this role, you will have the responsibility to drive and oversee clinical monitoring, manage clinical trial conduct and collaborate with like-minded clinical trial managers on implementation of best practices and efficiencies. You will be an important leader within the larger clinical development organization to champion patient safety, patient care and advance our highly innovative therapies through clinical trial phases. You will have an opportunity to work with other cross-functional leaders at Poseida as well as with dedicated vendors and clinical investigative sites to achieve the goal of delivering excellence in clinical trial execution and study management.

Position Summary

Poseida Therapeutics, Inc. is seeking a talented Clinical Trial Manager to join our team. This position offers an excellent opportunity for a highly motivated individual to contribute to innovative clinical trials for new CAR-T, gene editing and gene therapy products in an exciting and dynamic environment focused on cutting-edge gene editing technology. The Clinical Trial Manager will be accountable for the overall coordination and execution of clinical trial activities, including monitoring oversight. This role is expected to manage and oversee all study-level vendor and site related activities and issues related to one or more clinical trials, as needed.

Responsibilities 

These may include but are not limited to:

• Responsible for coordination/execution of all operational aspects of clinical studies, including study start-up, patient enrollment and follow up, and study closure activities. Develop and manage study budgets, timelines, and resource requirements. Manage all outsourced activities for assigned trials. Provide management level representation during audits.
• Prepare and update clinical protocols, informed consents, case report forms, clinical study reports, and other study-related documents in consultation with cross-functional project team members.
• Perform co-monitoring and oversight visits at participating sites with or without assigned CRO monitors.
• In consultation with cross-functional team members, ensures compliance with the Investigational Plan and appropriate regulations, guidelines, and policies.
• Oversee investigational site startup activities, including the preparation and review of study documents (e.g., ICFs, CRFs, study manuals, study binders, etc.), reviewing/approving essential regulatory document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.
• Conduct/supervise training of CRO monitoring staff, investigators, and site staff.
• Set-up and maintain (or supervise) accurate study status and accountability logs.
• Review data listings and tables. Partner with data management to ensure timely management and resolution of data queries.
• Oversee operations of clinical studies to ensure compliance with the study protocol, timeline and budget.
• Coordinate contract vendors and Clinical Research Organizations activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
• Partner with CRO to develop and revise study specific plans, detailed timelines and ensure that transferred obligations and performance expectations are met.
• Assist with protocol, case report form, source document template development, internal SOP/guideline development, and final report preparation.
• Assist in the management and preparation of and participate in Investigator Meetings (as applicable).
• Lead and/or participate in project team meetings and conference calls to review progress of ongoing clinical trials.

Requirements

Requirements, Knowledge, Skills and Abilities

• BS/BA in Biological Sciences, Life Sciences, or healthcare required with 5 plus years clinical operations experience in biotech, pharma or CRO setting (an equivalent combination of education and experience may be considered). MS or equivalent preferred.
• At least 2 years in a study leadership role (Clinical Trial Manager or equivalent).
• At least 2 years of experience as a clinical research associate (CRA) or lead CRA with on-site monitoring at academic and/or oncology centers preferred.
• Experience managing oncology clinical trials from protocol development to final report.
• Experience managing multiple myeloma and hematology cancer trials preferred.
• Experience managing chimeric antigen receptor cell (CAR-T) studies preferred.
• Working knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials.
• Ability to travel up to 25%.
• Ability to deliver results and execute on required activities individually and in a team setting.
• Organized and detail-oriented.
• Strong communication skills in a compact clinical team working with aggressive timelines.
• Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology.
• Computer skills (MS Office products, word processing, spreadsheets, etc.)

Clinical Trial Manager Pay Rate: $123,000 to $144,000 annually

The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc.

Who We Are and What We Do 

Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients’ lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single treatment cures for patients in need. Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics.

At Poseida we put people first. Our team is passionate about improving patients’ lives through innovation. See what our team has to say about our culture:

“My favorite part about Poseida is all the people that I get to work with. Everyone is so passionate about what we’re doing here and there’s so much camaraderie. It feels like one big enthusiastic family.”

“My favorite part about working at Poseida is the amazing culture and working environment. Everybody is friendly, professional, collaborative, and has a remarkable can-do and positive attitude.”

As we advance our compelling pipeline, there are endless opportunities for impact and growth. We encourage you to apply today!

Recruitment Fraud Alert

Alert: Beware of Employment Scams 

Poseida Therapeutics, Inc. has received reports of employment-related scams. These scams have appeared in forms of false job advertisements and/or unsolicited contacts via communication/chat platforms, phone, email or text from individual(s) claiming to be or represent Poseida’s Human Resources team. Be advised that Poseida Therapeutics does not extend unsolicited employment offers. Furthermore, Poseida Therapeutics does not request payment information or charge prospective employees with any fees during the recruitment process.

If you would like to pursue employment opportunities with Poseida Therapeutics, Inc., please visit our official careers website https://poseida.com/careers-culture/ or official Poseida Therapeutics LinkedIn page. Job postings that do not link directly to our careers website or official Poseida LinkedIn page are not legitimate and might be fraudulent. You may report fraudulent job advertisements or contacts via our Contact Us page at https://poseida.com/contact-us/ and select the subject “Careers.” If you have been defrauded or suspect identity theft as a result of an employment scam, please contact your local law enforcement agency for guidance.