Senior Director/VP, Pharmacology and Toxicology Req #2056

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches.This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. For more information, please visit www.Encoded.com.

The Senior Director/VP, Pharmacology and Toxicology is an experienced drug development scientist who will oversee nonclinical programs to support Encoded’s pipeline of gene therapy products. Under the direction of the Chief Scientific officer, this individual will coordinate and manage various research, proof-of-concept and other non-clinical studies leading to regulatory filings (pre-IND, IND, CTA, and eventually BLAs). Experience in integrated strategic regulatory writing for gene therapy products, ability to facilitate effective cross-functional collaboration and coordination of activities with external groups such as academic or industry partners, vendors (CROs, central laboratories, etc) are required.

Responsibilities

• Oversees and manages Encoded’s preclinical portfolio of studies for POC, pre-IND, CTA and IND submissions and eventually for BLA submissions
• Manage collaboratively the nonclinical development programs and timelines with input from bioanalytical, in vivo, clinical, quality, and regulatory teams
• Design in vivo studies (non-GLP and GLP) to support discovery and development efforts across programs
• Develop, review, and approve study protocols, test methods, study reports, and preclinical regulatory filings
• Provide pharmacology and toxicology expertise in the analysis and interpretation of nonclinical results and integrate with the development program
• Author and review the nonclinical component of regulatory submissions with cross-functional data integration and contribution from SMEs
• Communicate nonclinical safety findings to cross-functional teams with a balanced and clear point of view
• Manage department growth and oversight of preclinical scientists and technicians in the conduct of preclinical studies
• Prepare for and participate in regulatory interactions
• Prepare scientific abstracts and manuscripts, and present information at scientific meetings to disseminate results of preclinical studies
• Work with accounts payable and finance on non-clinical budgeting and forecasting for development programs

Requirements

• PhD in Pharmacology and Toxicology or equivalent degree, DABT or equivalent
• 10+ years of experience in the pharmaceutical industry with track record of successful nonclinical regulatory submissions
• Extensive hands-on experience in designing and executing on in vivo pharmacology and toxicology studies
• Strong practical knowledge of GLP and GMP requirements
• In-depth knowledge and first-hand experience of the regulatory environment (US & Europe) for drug development (preclinical and clinical)
• Gene therapy drug development experience
• Strong scientific writing skills and experience in preparation, strategy, design, writing and editing of regulatory documents (pre-IND packages, INDs, CTAs, BLA, etc)
• Broad understanding of the regulatory process, including CMC, non-clinical and clinical and the various stages of development of gene therapy products
• Excellent organizational, interpersonal skills, and ability to effectively communicate across internal multidisciplinary teams
• Integrity, teamwork, and commitment to excellence

Preferred Qualifications

• Gene therapy field In-depth knowledge and first-hand experience of the regulatory environment (US & Europe) for drug development (preclinical and clinical)

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Fully stocked kitchen

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.