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Sr Director/Vice President of Regulatory Sciences

Company: Strand Therapeutics
Location: Cambridge
Posted on: May 12, 2022

Job Description:

Strand Therapeutics is an early-stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies. Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. This collaboration led them to build their own mRNA "programming language," creating the world's first platform for mRNA smart therapies. The founders and scientific advisors of Strand Therapeutics are made up of well-known and highly regarded individuals in both academia and the biotech industry. Our corporate headquarters are located in of Cambridge, MA, with additional sites in Boston and Watertown, MA. Become the next standout single strand! Job Summary: Strand is looking to build a team that understands the value of working at a start-up. Joining Strand now places you alongside the founding executive team and world-leading advisors. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work closely with the founding team, and be a part of the growth strategy of the company. We are looking for a highly motivated and enthusiastic leader for the role of Sr Director/Vice President of Regulatory Sciences. Reporting to the President, Co-Founder & Head of R&D, the Sr Director/Vice President of Regulatory Sciences will manage and lead all regulatory efforts for the organization. This individual will build out an internal regulatory function and help streamline all major milestones as the regulatory strategist for our lead asset, STX-001. This will also be an opportunity to work closely with various cross functional teams to prepare for regulatory interactions and drive the development of our programs forward. Primary Responsibilities:

  • Responsible for developing and driving the regulatory strategy for our lead asset and other candidates entering the pre-clinical development phase.
  • Serve as Strand's point of contact for all regulatory interactions including the preparation and leading of meetings with regulatory agencies (INTERACT, pre-IND etc.).
  • Key thought partner to Research and Development in developing preclinical deliverables that lead to a successful IND in a timely manner.
  • Bring regulatory innovation to Strand's innovative programmable mRNA-based therapeutics that helps us bring effective therapies to the clinic fast. Qualifications:
    • 10+ years of regulatory strategy experience in biotech; Experience working in a smaller, fast paced environment highly preferred.
    • Extensive experience with the development and preparation of regulatory submissions including briefing books and/or INDs, especially in the field of gene therapy with a focus on oncology required.
    • Prior experience serving as the point of contact to regulatory agencies is a must. CBER/OTAT experience is desirable. Experience interacting with global health authorities such as EMA, PMDA, and familiarity with Australian CTN is a plus.
    • Collaborative mindset with strong interpersonal skills with the ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization.
    • Strong organizational and time management skills. Strand offers a fast-paced, entrepreneurial, team-focused work environment. We also offer a top-notch benefits package (health, dental, life, vacation, 401k, and commuter) and work/ life integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet the company goals. Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates. Job Type: Full-time Salary: Commensurate with role and experience

Keywords: Strand Therapeutics, Cambridge , Sr Director/Vice President of Regulatory Sciences, Executive , Cambridge, Massachusetts

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