Clinical Trial Manager
ViaCyte is a privately-held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte’s product candidates are based on the derivation of pancreatic progenitor cells from stem cells, which are then implanted in durable and retrievable cell delivery devices. Once implanted and matured, these cells are designed to secrete insulin and other pancreatic hormones in response to blood glucose levels. ViaCyte has two product candidates in clinical-stage development. The PEC-Direct™ product candidate delivers the pancreatic progenitor cells in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap™ (also known as VC-01) product candidate delivers the same pancreatic progenitor cells in an immunoprotective device and is being developed for all patients with diabetes, type 1 and type 2, who use insulin. ViaCyte is also developing immune-evasive ‘universal donor’ stem cell lines, from its proprietary CyT49 cell line, expected to further broaden the availability of cell therapy for diabetes and other indications. ViaCyte is headquartered in San Diego, California. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.
The Clinical Trial Manager will assist and work in collaboration with the Director, Clinical Development, 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.
- Establish and maintain Clinical Development Plan timelines for ViaCyte clinical studies.
- Assist with the projection, tracking, management and analysis of study budgets by establishing purchase orders, maintaining study accounting spreadsheets, and reviewing, approving, and filing invoices for service and supply vendors.
- Select, manage, and oversee the performance of clinical trial vendors by acting as the primary interface with vendors, driving performance as per the scope of work, negotiating and updating agreements/change orders, and ensuring pertinent documentation is obtained and filed.
- Providing internal stakeholders with relevant status updates and information on trial activities to streamline company efforts.
- Lead, organize, assign, and track tasks assigned to clinical team members (e.g., consultants or in-house team) on studies managed internally.
- Ensure clinical sites are provisioned with appropriate supplies, investigational product, and associated documentation via coordination and scheduling of requests with internal resources.
- Facilitate efforts to identify potential subject safety issues by obtaining relevant data and distributing and/or reviewing reports.
- Assist with establishing and updating internal procedures to maintain adherence to clinical trial operations.
- Participate in meetings and conference calls with CROs, vendors, and cross-functional teams.
- Assist the CMO/Director/Sr. Director with additional tasks as assigned.
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.
This position requires a bachelor’s degree, life sciences preferred, and 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 diabetes, metabolic disease, cell therapy, 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.
For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2018-9 and your full name. Send to firstname.lastname@example.org. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.
It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.
ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recreational programs.