Director Clinical Data Management
San Diego, CA - Hybrid
200,000-230,000
A clinical-stage cell therapy company in San Diego is expanding its clinical data management team. Specializing in treatments for autoimmune diseases and hematological cancers, the company employs a novel approach by utilizing Natural Killer (NK) cells that specifically target B cells. These NK cells are engineered as "off-the-shelf" therapy, meaning they are pre-produced rather than sourced from a patient's own cells, enhancing accessibility and scalability.
As pioneers in cell therapies, the team made one of the first IND filings for Lupus using cell therapy. Currently, they are advancing six indications, with four in clinical stages. The company is focused on streamlining manufacturing and distribution to improve access to innovative treatments. The CEO has over 20 years of experience in biotech and venture capital, with leadership roles in prominent life sciences companies, while the CMO has a strong background in clinical research from leading pharmaceutical firms. This role offers the chance to contribute to the ongoing development of therapies at the intersection of cell therapy and auto-immunology.
Key Responsibilities
* Support the management of clinical trial activities to ensure studies are completed on time, within budget, and in compliance with regulatory standards, standard operating procedures (SOPs), and ICH/GCP guidelines.
* Help oversee essential trial aspects, including study start-up, patient enrollment, site interactions, and data management, proactively identifying and resolving issues.
* Draft and review key study documents, including informed consent forms, case report forms, study manuals, and other trial materials.
* Assist in selecting and managing study sites and evaluating CROs and other service providers, as well as overseeing contracts and budgets.
* Work towards project goals, managing timelines and deliverables to align with organizational objectives.
* Provide study updates to cross-functional teams and help address issues with sites and CROs through analysis and action planning.
* Contribute to the development of study tools and resources to enhance data quality and trial efficiency.
* Participate in training new team members on study processes as needed.
* Track study progress, maintain relevant metrics, and keep the team informed.
* Serve as a key point of contact for study sites, and participate in assessing and resolving any safety or patient care issues.
* Oversee and support contract and budget negotiations with clinical sites.
* Assist in planning and presenting at investigator and CRO training meetings.
* Conduct site visits as needed, including qualification, initiation, monitoring, and close-out visits; perform oversight visits to review and assess CRO activities.
* Support internal and external audits, helping to address and resolve any findings.
Qualifications and Experience
* Bachelor's degree in a scientific or health-related field.
* At least 2 years of experience in clinical research, ideally within a biopharmaceutical or CRO setting.
* Autoimmune trial experience is highly preferred; early-phase development experience is beneficial.
* Knowledge of FDA regulations and ICH/GCP guidelines is essential.
* Strong organizational and multitasking skills, with the ability to work in a collaborative team environment.
* Excellent written and verbal communication skills.
* Problem-solving and negotiation abilities, with the ability to adapt as needed.
* Proficiency in Microsoft Office and experience with clinical trial management systems (e.g., Medidata Rave, InForm).
