Company Summary:
Tessera Therapeutics is pioneering Gene Writing™— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.
Team and Position Summary:
Tessera is starting to build an agile, rapidly growing and highly innovative and collaborative Regulatory Science Team to partner with regulators on the development of its next-generation gene therapy products using science-based and data driven arguments coupled with transparent and proactive communication. The goal of the development team, including Regulatory Science, is to bring transformative therapies to patients with serious diseases and unmet medical need in an efficient manner.
The Manager in Regulatory Science will be responsible, with support from the Head of Regulatory Strategy, for the preparation and submission of initial new drug (IND) applications in the US and clinical trial applications (CTAs) ex-US, as well as amendments to these applications. The Manager will also contribute to the preparation and submission of meeting requests and meeting packages to support interactions with Regulators, such as pre-IND meetings with the Food and Drug Administration or Scientific Advice meetings with the European Medicines Agency.
Key Responsibilities:
Qualifications:
More About Flagship Pioneering
Flagship Pioneering has conceived of and created companies such as Moderna Therapeutics (NASDAQ: MRNA), Editas Medicine (NASDAQ: EDIT), Omega Therapeutics (NASDAQ: OMGA), Seres Therapeutics (NASDAQ: MCRB), and Indigo Agriculture. Since its launch in 2000, Flagship has applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures. In 2021, Flagship Pioneering was ranked 12th globally on Fortune’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies.
Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.
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