Vice President of Regulatory Sciences

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

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. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established multiple programmable mRNA platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a Phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

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 Vice President of Regulatory Sciences. Reporting to the President, Co-Founder & Head of R&D, the 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 multiple assets both clinical stage and pre-clinical across various global territories. 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 management and leadership of Regulatory Affairs including Global Strategy, CMC, Operations, management of Regulatory Vendors, and build of the Regulatory Affairs function and processes.
• Responsible for developing and driving the regulatory strategy for clinical stage lead asset and other candidates at the pre-clinical development phase using and understanding the scientific principles that underly Strand’s technology.
• Bring regulatory innovation to Strand’s programmable mRNA-based therapeutics that supports efficient transition through clinical development.
• Serve as Strand’s point of contact for all regulatory interactions including the preparation and leading of meetings with global regulatory agencies.
• Establish positive relationships with regulatory agency personnel. Organize and manage participation in meetings and prepare internal teams for regulatory interactions. Negotiate with regulatory authorities regarding company submissions as relevant.
• Key thought partner to Research and Development in developing preclinical deliverables that lead to successful submissions in a timely manner.
• Provide regulatory oversight and guidance to project teams on compliance, health authority requirements, clinical study design, and overall strategy.
• Evaluate and implement emerging AI and digital technologies to streamline submission processes and enhance regulatory strategy and decision-making across regulatory functions.

Qualifications:

• Bachelors degree in a scientific discipline required with a preference for a Masters, PharmD, PhD or other Advanced Degree preferred.
• 15-20+ years of regulatory strategy experience in biotech; Experience working in a smaller, fast paced environment highly preferred.
• Excellent written and spoken communication skills
• Agile and flexible with problem-solving and innovative mindset in developing regulatory strategy
• Extensive experience with the development and preparation of regulatory submissions including briefing books, INDs, and BLAs (including expedited pathways) required.
• Regulatory experience within the field of oncology required, with mRNA and gene therapy experience being highly preferred. Experience with rare diseases is a plus.
• Proven track record of successfully partnering with and serving as the primary point of contact to regulatory agencies such as CBER is a must.
• Solid knowledge of FDA, EMA and ICH guidelines and regulations.
• Prior interactions and experience with global health authorities such as EMA, PMDA, and TGA is a plus.
• Strong project management skills, with proven track record of delivering high impact results.
• 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 small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and 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 Strand’s 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: $315,000 - $365,000 annually plus bonus and equity incentives