Vice President of Regulatory Sciences

Strand Therapeutics • Boston, MA

239d

About The Position

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 three 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!

Requirements

• Bachelor's degree in a scientific discipline required; preference for a Masters, PharmD, PhD or other Advanced Degree.
• 15-20+ years of regulatory strategy experience in biotech; experience in a smaller, fast-paced environment 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 required.
• Regulatory experience within the field of oncology required; mRNA and gene therapy experience highly preferred.
• Proven track record of successfully partnering with and serving as the primary point of contact to regulatory agencies such as CBER.
• Solid knowledge of FDA, EMA and ICH guidelines and regulations.
• Strong project management skills with a proven track record of delivering high impact results.

Nice To Haves

• Experience with rare diseases is a plus.
• Prior interactions and experience with global health authorities such as EMA, PMDA, and TGA is a plus.

Responsibilities

• Manage and lead all regulatory efforts for the organization.
• Build out an internal regulatory function and streamline major milestones as the regulatory strategist for multiple assets.
• Develop and drive the regulatory strategy for clinical stage lead asset and other candidates at the pre-clinical development phase.
• Serve as Strand’s point of contact for all regulatory interactions and lead meetings with global regulatory agencies.
• Establish positive relationships with regulatory agency personnel and prepare internal teams for regulatory interactions.
• 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.

Benefits

• Health insurance
• Dental insurance
• Life insurance
• Open PTO
• Onsite lunch catering
• Commuter support
• Work/life flexibility and integration

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 101-250 employees