Senior/Executive Director, Translational Sciences & Nonclinical Operations

March 19

Apply Now

Receive Emails with Similar Jobs

ReCode Therapeutics

WebsiteLinkedInAll Job Openings

Powering the next wave of genetic medicines through superior delivery

RNA Therapies • Genetic Medicines • Non-Viral Lipid Nanoparticles • Genetic Respiratory Disease • Cystic Fibrosis

11 - 50

💰 $15M Grant on 2023-01

Description

• Oversee and provide strategic direction for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams • 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 • Strong understanding of science and drug development • Comprehensive knowledge of GLP regulations • Background in rare diseases, genetic medicines, gene therapy and/or lipid nanoparticles a plus • Strong knowledge of global regulatory requirements • Excellent communication and interpersonal skills • Strong leadership skills, high scientific integrity, and ability to positively influence cross-functional efforts to drive optimal outcomes for programs

Benefits

• 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