Director, Clinical Data Management
Clinical | Hybrid in Brisbane, CA | Full Time
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger’s disease and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Vera Therapeutics Inc. is a clinical-stage biotechnology company developing innovative biologic therapeutics with transformative clinical potential. We seek a highly skilled and motivated Director, Clinical Data Management to join a fast-paced and collaborative team. The Director is responsible to create the infrastructure of the clinical data management (CDM) function within Vera. Additionally, the role is responsible for the planning and oversight of CDM activities, and vendor management from start-up through database lock and clinical study report within timelines, budget and with the highest quality.
- Lead and oversee all CDM aspects of program/study implementation from start-up through database lock and clinical study report in alignment with the clinical development program.
- Lead, manage and oversee CDM vendor service activities in a fully outsourced model.
- Accountable for ensuring complete, accurate, high quality clinical data for outsourced trials.
- Lead CRF design, guidelines and standards and provide oversight and expertise into database development.
- Development of timelines data cleaning process that maintains data integrity.
- Manage clinical data quality plans and data transfers specifications.
- Contribute to sponsor quality/risk management, oversight and monitoring of clinical development programs.
- Manage and provide oversight clinical data flow with ancillary vendors including IXRS, eCOA, central lab, imaging, and other systems and services, as needed.
- Manage and provide oversight of the CDM section of Trial Master File
- Develop company SOP, work instructions and training for clinical data management staff. Ensure adherence with SOP, applicable regulations, GCP, and ICH guidelines.
- May travel up to 10%, as needed, to support clinical development programs.
- BS or higher in life sciences or health-related field.
- 10+ years progressive clinical data management experience within the pharmaceutical or biotechnology industry.
- 4+ years experience in managing, mentoring and developing junior staff.
- Flexible self-starter to operate in a fast-pace start-up environment. Ability to develop out of the box solutions with limited infrastructure.
- Experience is all aspects of clinical data management.
- Working knowledge of GCP, ICH guidelines and FDA regulations.
- Ability to work independently as well as collaboratively in cross-functional team environment.
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook, Project).
- Strong interpersonal skills with excellent oral and written communication.
- Innovative, analytical and extremely organized to drive projects to completion.
- Ability to operate in alignment with Vera’s core values
Vera Therapeutics Inc. is an equal opportunity employer.