Chief Medical Officer

Who We Are:

We are a clinical stage company powering the next wave of genetic medicine through superior delivery with our next-generation lipid nanoparticle delivery platform. Our mRNA and gene editing therapeutics have the potential to directly replace or address underlying genetic mutations in a vast range of diseases starting with primary ciliary dyskinesia and cystic fibrosis. Our selective organ targeting (SORT) LNP platform is uniquely differentiated to enable the delivery of diverse genetic payloads to tissues beyond the liver.

At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission. Our team is uniquely positioned to tackle this challenge, given our extensive experience in lipid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing, gene editing, and rare disease drug development. We are a high performing, highly functional organization with a culture that is caring and strives to enable every member of our team to thrive.

Summary of Position:

ReCode Therapeutics is seeking a Chief Medical Officer with significant drug development experience and expertise in orphan disease with a preference for orphan respiratory diseases. Additional expertise in genetic medicine with cargoes such as mRNA or other genetic therapeutics would be helpful. The CMO will report to the CEO and will be a key member of the executive leadership team. The CMO will lead the strategy, direction, and execution of ReCode’s clinical development programs and will be able to oversee the overall development strategy for ReCode’s emerging genetic medicine’s portfolio across other indications in musculoskeletal and CNS diseases.

Responsibilities:

• Lead the design of clinical development plans, study protocols and interpretation of clinical study data. Execute drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and

• Manage interactions with key opinion leaders, clinical trial investigators, collaborators, and other external stakeholders and interface directly with regulatory agencies
• Partner with cross-functional development teams including program management, translational sciences, CMC, and regulatory to ensure successful achievement of program milestones

• Provide clinical leadership for mRNA drug discovery and development, and serve as lead for clinical development, medical affairs, clinical operations, clinical pharmacology in multiple therapeutic areas.
• Serve as the clinical/medical representative on ReCode’s integrated portfolio development team which develops portfolio strategy, prioritization, and program transition decisions.
• Act as our internal clinical/medical advisor for projects from research through development.
• Lead the design of clinical development plans, study protocols and interpretation of clinical study data. Execute drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and
• Build a robust, forward-thinking clinical team at the appropriate inflection points in order to support all goals and timelines.
• Conduct investigator meetings and lead site initiation visits with clinical trial
• Implement safety strategy across studies, including regular review of safety data and response to safety issues. Monitor/analyze clinical trials for safety and, when appropriate, efficacy, and ensure timely generation of clinical study reports and reporting of safety signals to regulatory
• Lead clinical sections of regulatory documents (e.g., pre-IND meeting packages, IND/CTA, IB, ICF and BLA/NDA), prepare for meetings with FDA and healthcare authorities and organize and prepare for Clinical Advisory meetings.
• Manage the writing of clinical protocols, presentations, and publications.
• Represent the Company externally to investigators and trial site administrators and serve as subject matter expert on all clinical and medical strategic initiatives.
• Maintain accountability for all relevant timelines and deliverables. Lead clinical team to secure global regulatory approvals for pipeline products.
• Evaluate the balance between outsourcing and in-house approaches for the various clinical development needs.

Qualifications:

• MD with a background in pulmonology and/or rare genetic disease preferred
• 10+ years of experience in the biotech/pharmaceutical industry
• Proven track record of designing and leading clinical trials across all phases of drug development
• Deep knowledge of regulatory guidelines and prior experience interacting with regulatory agencies and health authorities
• Excellent leadership skills with demonstrated ability to build and manage successful teams
• Strong communication and interpersonal skills with proven ability to collaborate effectively with peer across all functions
  
  

Salary Range: *

*450-460K - Please note that for remote positions, salary may be adjusted for cost of living

Benefits Offered:

• No premium cost for employees - 100% subsidized by ReCode for full-time employees
• Company 401k contribution
• 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
• Mental health support for employees & their families
• FSA available, including a lifestyle spending account subsidized by company
• Employee discounts at hotspots

ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.

ReCode Therapeutics is an Equal Opportunity Employer.