Turnstone Biologics (“Turnstone”), a privately held clinical stage biotech company, is developing breakthrough cancer immunotherapies by advancing two leading and complementary platforms that drive innate and adaptive tumor immunity, to provide benefit to the millions of cancer patients underserved by current treatment options. Turnstone’s proprietary vaccinia virus platform is engineered to drive coordinated immune activation, potent viral activity, and local expression of encoded therapeutics. The innovative TIL cell therapy platform leverages clinically validated treatment protocols and has been specifically designed to extend beyond the use of bulk TILs to enrich for the most relevant T-cells for tumor eradication, preserving broad antigen diversity and minimizing time to treatment for patients. The Company has an ongoing Phase 1/2a trial in solid tumors (RAPTOR) for its leading oncolytic virus candidate, RIVAL-01, and is expecting to file an IND for the lead TIL therapy candidate, TIDAL-01, in 2021. 

 

At Turnstone, the science drives decision-making and our therapeutics are designed with the patient foremost in mind. We continue to build a world-class, high-performing company that embraces being a learning organization with a sense of urgency. Imagine coming to work every day where over-communication, transparency, teaching, listening, asking, thinking, working hard, and having fun are normal – actually, expected? Imagine having a coach, mentor, peers, and partners where candid feedback, self-improvement, risk taking, failing, learning from that failing, and succeeding thereafter are what we call ‘another day at Turnstone’? If you are a passionate person, and our science excites you – this opportunity may be for you.

 

Job Description

 

·       Assist in the preparation of regulatory submissions for Turnstone’s investigational products

  • Maintain and share regulatory documentation in a cloud platform
  • Management of Regulatory vendors, including co-ordinating reviews of service agreements/ proposals, requesting purchase order (PO) numbers, processing invoices, and tracking invoices against POs and budgets
  • Participate in cross-functional team meetings
  • Effectively prioritize, coordinate and complete multiple projects within established timeframes as assigned
  • Develop and maintain regulatory and document knowledge

 

 

Requirements

  • Bachelor’s or Master’s degree in a life sciences discipline; diploma or certification in Regulatory Affairs an asset
  • 1-3 years of experience in regulatory affairs; experience with biological products, including cell and gene therapy, an asset.
  • Direct and working knowledge of regulatory submission types, including initial IND/CTA applications, amendments, annual reports, safety reporting, and submissions related to genetically modified organisms; experience with U.S. and ex-U.S. jurisdictions an asset.
  • Proficient computer application skills including Microsoft Office (Outlook, Excel, Word, Powerpoint) and Adobe; experience with cloud platforms an asset
  • Demonstrated ability to work in a cross-functional, multidisciplinary team environment
  • Demonstrated strategic planning, time-management, and problem-solving skills
  • Excellent written and verbal communication skills
  • Attention to detail

·       Ideally located in the San Diego, US.  Candidates from Ottawa, CA will also be considered.

 

 

Turnstone Biologics welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.  We thank all applicants for their interest, however, only those selected will be invited for an interview.