Senior/Executive Director, Translational Sciences & Nonclinical Operations

$300,000 - $300,000/Yr

Recode Therapeutics - Menlo Park, CA

Full-time - Senior

Onsite - Menlo Park, CA

Chemical Manufacturing

About the position

ReCode Therapeutics is a clinical-stage genetic medicines company that is pioneering the use of precision delivery systems to enhance the efficacy of mRNA and gene correction therapeutics. The company’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform allows for targeted delivery of genetic medicines to specific organs, tissues, and cells, which is crucial for treating diseases effectively. ReCode's lead programs, RCT1100 and RCT2100, are focused on treating primary ciliary dyskinesia and cystic fibrosis, respectively, utilizing inhaled mRNA-based therapies formulated with the SORT LNP delivery system. As the company expands its pipeline, it aims to develop therapies for a range of genetic diseases, including those affecting the musculoskeletal system, central nervous system, liver, and infectious diseases. In the role of Senior/Executive Director of Translational Sciences & Nonclinical Operations, you will be a key leader within ReCode Therapeutics, reporting directly to the Senior Vice President of Early Development. This position is critical for shaping the nonclinical and translational sciences strategy, ensuring that it aligns with clinical development plans, and effectively navigating the regulatory pathways necessary for clinical development and marketing approvals. You will oversee various teams, including Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology, ensuring that they provide robust support for clinical development programs. Your leadership will be essential in delivering high-quality data packages to regulatory authorities and collaborating with cross-functional teams to align nonclinical deliverables with clinical objectives. The position requires a proactive approach to developing and implementing strategic plans for nonclinical operations, anticipating challenges, and ensuring the organization is prepared to address them. You will also be responsible for maintaining awareness of the evolving scientific and regulatory landscapes, which will inform the design of approval pathways. Additionally, you will identify and manage external consultants and subject matter experts to enhance functional strategies based on the latest scientific insights. This role also involves fostering collaborations with key opinion leaders and external partners, supporting the preparation of regulatory submissions, and mentoring project leads in a matrix environment. The opportunity exists to take on full project team leadership responsibilities for dedicated programs based on your interests and bandwidth.

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.

Requirements

• 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.

Nice-to-haves

• Experience with regulatory submissions and interactions with health authorities.
• Familiarity with the latest advancements in genetic medicine and therapeutic development.

Benefits

• 100% health insurance premium coverage for 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 the company.
• Employee discounts at hotspots.