Position Summary:
We are seeking an experienced and dynamic leader to join ReCode Therapeutics as the Head of Translational Sciences & Nonclinical Operations. In this role, you will report into our SVP of Early Development and will play a pivotal role in driving the nonclinical and translational sciences strategy, ensuring alignment with clinical development plans, and navigating regulatory pathways to support clinical development and marketing approvals.
Responsibilities:
- Oversee and provide strategic direction for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams to ensure robust support for clinical development programs.
- Assume responsibility for delivering high-quality data packages to regulatory authorities, supporting marketing approvals.
- Collaborate closely with cross-functional teams to align nonclinical and translational sciences deliverables with clinical development plans.
- Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances and minimize potential impact on timelines.
- Develop and implement strategic plans for nonclinical operations, anticipating challenges and ensuring the organization is well-prepared to address them.
- Maintain a proactive approach to adapt functional strategies to the evolving scientific and regulatory landscapes, monitoring the regulatory and competitive landscape to design base case and best case scenarios for regular and expedited global approval pathways.
- 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.
- Foster collaborations with key opinion leaders and external partners to stay at the forefront of developments in translational sciences.
- Support and coach subject matter experts in the authoring and preparation of CTD/CTA modules, providing guidance in responding to health authority queries and contributing to the preparation of briefing documents for health authority interactions as needed
- Act as program lead for translational deliverables on selected key programs and/or oversee and mentor program/project translational lead(s) in a matrix environment
- Opportunity to take on full (end-to-end) project team leadership responsibilities for dedicated program(s) based on bandwidth and interest
Qualifications:
- Advanced degree in life sciences or medicine (PhD/MD/PharmD preferred)
- 12+ years of experience in the biopharma industry in non-clinical development (toxicology, pharmacology, pharmacokinetics, bioanalytical sciences, or related discipline)
- Strong understanding of science and 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 transferable experience
- Background in rare diseases, genetic medicines, gene therapy and/or lipid nanoparticles a plus
- Strong knowledge of global regulatory requirements, including FDA (CBER), EMA, MHRA, and other major regulatory authorities with prior experience supporting regulatory submissions.
- Excellent communication and interpersonal skills with the ability to collaborate and work effectively in a cross-functional, fast-paced environment.
- Strong leadership skills, high scientific integrity, and ability to positively influence cross-functional efforts to drive optimal outcomes for programs.
Salary Range: 265-300K
*Please note that for remote positions, salary may be adjusted for cost of living