Summary of Position:

We are seeking an experienced and dynamic leader to join ReCode Therapeutics as the Head of Nonclinical Development. In this role, you will report into our SVP of Early Development and will help drive innovative nonclinical strategies for ReCode’s programs. This includes ensuring thoughtful design and execution of regulated pharmacology, toxicology, and bioanalytical work in alignment with overall program plans, timelines and goals and navigation of nonclinical regulatory requirements to enable clinical development and future marketing approvals.

Responsibilities:

• Provide strategic direction and oversight for nonclinical aspects of ReCode’s development programs.
• Drive successful completion of program requirements including but not limited to: Toxicology/Pathology, GLP Bioanalytical/DMPK, and Clinical Pharmacology deliverables to ensure robust and timely support for clinical development plans.
• Assume responsibility for delivering high-quality data packages to regulatory authorities, to support early global scientific advice and program advancement through marketing approval.
• Collaborate closely with cross-functional teams to align all nonclinical and translational deliverables with clinical development plans.
• Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances and minimize potential impact on timelines.
• Partner closely with nonclinical operations, anticipating challenges and identifying creative solutions to ensure that the organization is well-prepared to address and/or mitigate.
• Author, review, and preparation key nonclinical documents and associated deliverables for CTD/CTA modules, responding to health authority queries and contributing to the preparation of briefing documents for health authority interactions.
• Oversee and mentor program/project translational lead(s) in a matrix environment.
• Identify, retain, and manage consultants and external subject matter experts (SMEs) as needed to enhance and adjust functional strategies based on the latest scientific insights and regulatory requirements.
• Maintain a proactive approach to adapt functional strategies to the evolving scientific and regulatory landscapes including monitoring the regulatory and competitive landscape to design base case and best-case scenarios for both traditional and expedited global approval pathways.
• Foster collaborations and establish an external presence for ReCode as a leader of innovative nonclinical development of gene therapy and lipid nanoparticle-based therapeutics, by working with industry consortia, key opinion leaders, and external partners to stay at the forefront of developments in nonclinical and translational science strategies.
• Act as a leader and steward of the 3Rs in development of nonclinical testing strategies.
• Opportunity to take on full (end-to-end) project team leadership responsibilities for dedicated program(s) based on bandwidth, experience, aptitude, and interest.

Qualifications:

• Advanced degree in life sciences or medicine (PhD/MD/PharmD).
• 12+ years of experience in the biopharma industry in nonclinical development (toxicology, clinical pharmacology, bioanalytical sciences, or related discipline).
• Strong scientific background and understanding of drug development, with specific expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study procedures, and statistical analysis methods.
• Comprehensive knowledge of GLP regulations, including previous GLP experience in pharmaceutical or biotechnology industry or equivalent GXP experience.
• Strong knowledge of global regulatory requirements, including FDA (CBER), EMA, MHRA, and other global regulatory authorities with prior experience drafting and supporting regulatory submissions/interactions.
• Background in rare diseases, genetic medicines, gene therapy and/or lipid nanoparticles is not required but is a plus
• Excellent communication and interpersonal skills with the ability to collaborate and work effectively in a cross-functional, fast-paced environment with an enterprise and growth-oriented mindset.
• Strong leadership skills, high scientific integrity, and ability to positively influence cross-functional efforts to drive optimal outcomes for programs.

Salary Range: $265K - $300K

*Please note that for remote positions, salary may be adjusted for cost of living