CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.
In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.
Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 industry veterans and scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our mission.
At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.
Reporting to the Head of Regulatory Affairs, the Associate Director, Regulatory Affairs CMC will provide support for the regulatory affairs department with a primary focus on driving cell and gene therapy projects that are developed in collaboration with MD Anderson Cancer Center and with biotechnology companies to IND filing and first-in-human clinical studies. The Associate Director, Regulatory Affairs CMC is responsible for leading and/or supporting regulatory activities supporting multiple projects per year as they progress from preclinical POC to clinical POC including development activities, pre-IND meeting preparation, incorporation of pre-IND meeting feedback into IND-enabling activities, IND preparation and submission, coordination with MD Anderson Cancer Center to enable study activation and ongoing monitoring in coordination with the Clinical Research Office.
CTMC has a unique, flexible and value-added partnership model with biotech companies and MD Anderson Cancer Center. The role will be a central player in this nexus and ensure clear communication of roles and responsibilities across the partners to enable efficient execution of IND-enabling activities, IND submissions and lifecycle management.
- Provide strategic, operational, and tactical regulatory advice in support of nonclinical and clinical development of early-stage cell and gene therapy products.
- Interface cross-functionally to facilitate integration of nonclinical and clinical plans with overall development plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones.
- Identify and assess regulatory risks and critical-path activities associated with nonclinical and clinical plans and work to identify regulatory strategies to mitigate risks.
- Support development of and/or review nonclinical data packages and provide comprehensive nonclinical roadmaps to make data packages more robust, complete, and likely to succeed in gaining regulatory agency approval.
- Provide hands-on contributions to regulatory filings including comprehensive review, and sometimes extensive editing/authoring, of nonclinical documents prepared by nonclinical Subject Matter Experts such as study protocols, study reports and nonclinical overviews to ensure essential items are thoroughly and appropriately addressed as well as clearly communicated.
- Collaborate with biotech and MD Anderson Cancer Center clinical teams in preparing clinical documents for regulatory filings such as clinical protocols, informed consent documents, investigational product manuals and lab manuals.
- Monitor and analyze regulatory agency activities regarding nonclinical and clinical development and assess potential impact on development programs.
- Responsible for overall planning, coordinating, and developing high quality, compliant and timely regulatory submissions that require extensive interaction with departments outside of Regulatory Affairs and outside of CTMC.
- Ensure submission readiness at the document-level, including document formatting and PDF generation, bookmarking and hyperlinking.
- Compile, publish and submit in eCTD via the Electronic Submissions Gateway using Veeva Vault RIM.
- Initiate or contribute to process improvements (e.g., policies, SOPs, work instructions) which have a significant impact on business.
- Other duties as required.
- Master’s degree in a relevant science discipline, or PhD preferred, minimum Bachelor’s degree required.
- 10 yr.’s relevant experience including 8+ yr.’s working within the biotech/pharmaceutical industry and 5+ yr.’s of biotech/pharmaceutical Regulatory Affairs experience or equivalent combination of education and experience.
- Prior experience with cell and/or gene therapy products.
- Prior experience in oncology drug development.
- Strong scientific background with understanding and experience in GLP, GCP, and relevant regulatory guidelines.
- Proven ability to contribute to and shape clinical development strategies and develop critical regulatory documents for regulatory filings with a focus on the FDA.
- Track record of successful interactions with regulatory authorities.
- Affinity with science and ability to interact with scientists and clinicians.
- Combine strategic thinking with the ability to execute, both individually and as a part of a team, to achieve operational excellence in the face of a challenging goal.
- Ability to “roll up your sleeves” to get it done.
- A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills.
- Strong attention to detail and an ability to prioritize effectively.
- Proficient in various computer applications such as Office suite, Veeva, Smartsheet, etc.
Working Conditions, Equipment, Physical Demands
Equipment- Computer, printer, fax and telephone
- Prolonged periods of sitting at a desk and working on a computer
The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.
The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.