Design Therapeutics is a clinical-stage biotechnology company developing a new class of therapies based on its platform of GeneTAC™ gene targeted chimera small molecules. The company’s GeneTAC™ molecules are designed to either dial up or dial down the expression of a specific disease-causing gene to address the underlying cause of disease. In addition to its lead GeneTAC™ small molecule, DT-216, in development for patients with Friedreich ataxia, the company is advancing programs in Fuchs endothelial corneal dystrophy and myotonic dystrophy type-1. Discovery efforts for multiple other serious degenerative disorders caused by nucleotide repeat expansions are also underway, including for fragile X syndrome, spinocerebellar ataxias, Huntington disease, spinobulbar muscular atrophy, and C9orf72-amyotrophic lateral sclerosis/frontotemporal dementia.

We are a group of passionate and experienced drug developers based in Carlsbad, California and since our inception in 2017.

The Clinical Trial Associate will assist and work in collaboration with the Program(s) Lead/Manager of Clinical Operations (or another member of the departmental leadership team), to ensure timely completion of program activities.  The essential duties and responsibilities will include, but are not limited to:

• Manage various aspects of day-to-day operations of clinical trials as assigned.
• Provide general support to the Manager and field Clinical Research Associates (CRAs) to manage the investigator sites and ensure compliance.
• Manage the collection, review and tracking of essential regulatory documents in support of new clinical study site activation.
• Oversee the development of study-specific documents, e.g., study guides, tools and informed consents.
• Manage and serve as a point of contact for contract research organization (CRO) and third-party vendors; identifying potential risks and proactively resolving issues that arise.
• Ensure all clinical sites are provisioned with appropriate ancillary supplies, investigational product, and associated documentation by establishing purchase orders, processing orders, and arranging for delivery by vendors and/or internal departments as necessary.
• Manage all investigational product (IP) requests, including, but not limited to: tracking of all IP shipping and delivery, IP accountability logs, and inventory reports.  
• Establish templates within electronic Trial Master File (eTMF) system.
• Collect and process electronic case report form (eCRF) access requests from clinical sites and internal team members.
• Assist in the development of reports for communicating study progress and key metrics to the management team.
• As needed, travel to investigator sites to assist with site monitoring, reviewing source documents, CRF entries, regulatory files, IP accountability records, and all other relevant study documents to ensure site compliance and data validity.
• Coordinate the development of Clinical Trial Agreements with appropriate Company business associate and develop, review, and negotiate study budgets.
• Provide guidelines for assessing adequacy of potential clinical investigators and sites: including evaluating facilities, personnel, patient referral base, and adherence to Good Clinical Practices (GCP).
• Schedule & set up necessary tele- or videoconferencing meeting requirements for Clinical Development/Clinical Operations team as needed.
• Capture and file minutes for in-house meetings and conference calls with CROs, vendors, and cross-functional teams. 
• Review and update Standard Operating Procedures (SOPs).
• Maintain effective communication with study teams throughout study cycle.
• Complete other study-related tasks as required by Clinical Development/Clinical Operations Team members.

Our dynamic workplace is attractive to those who are self-motivated and resourceful.  You will be expected to set priorities within your job scope and to meet critical deadlines.  Flexibility to handle rapidly changing objectives and timelines is essential.

• Bachelor’s degree, life sciences preferred
• A minimum of 3 years of biotechnology or industry related project management experience are required.
• An equivalent combination of education and experience is sufficient to successfully perform the job duties is acceptable. 
• Working knowledge of Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, ICH Guidelines, and other regulatory requirements is necessary. 
• Familiarity with rare disease, neurologicial or ophthalmic disease, and/or cutting edge translational medicine is strongly desired. 
• Strong verbal and written communication skills are required including ability to organize and present concepts with written, oral, and technical media / approaches. 
• Candidates must be skilled in Windows, Microsoft Project, and Microsoft Office.  Experience with electronic data capture / reviewing / interpreting data is desired.

No applications from recruitment agencies are being accepted at this time. 

The annual salary range for this position is $70,000 USD to $120,000 USD. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

 Employees in this position are eligible to participate in the Company’s 2021 Equity Incentive Plan. The amount of incentive varies and is subject to the terms and conditions of the plan.  Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and paid time off.