Vice President/Senior Director, Nonclinical Drug Safety & Toxicology

The role

The Vice President/Senior Director of Nonclinical Drug Safety and Toxicology will lead nonclinical aspects of all company pipeline programs. This person will provide strategic and operational leadership for the toxicology group across discovery, early development, and late development programs.

What you will do

• Create a long-term global toxicology strategy in alignment with company vision
• Lead scientific direction for global regulatory toxicology including safety pharmacology
• Lead scientific direction for safety assessments of discovery and early development programs
• Oversee toxicology findings and advise project teams and senior management
• Design and implement external toxicity studies for lead optimization and candidate selection
• Develop strategy, plan and budget to manage regulatory toxicity studies for IND and NDA submissions
• Work with internal R&D leaders and external parties including partners, consultants, and CROs
• Develop and manage all timelines related to this function
• Identify and engage experts in toxicology to interpret study results
• Communicate toxicity study results to teams, executive management, and Board of Directors

Required qualifications

• PhD in toxicology or related discipline with at least 15 years of experience, or an equivalent combination of experience and education
• Experience in defining and implementing scientifically relevant and compliant nonclinical toxicology strategies and contingency plans
• Proven track record of interfacing with global regulatory authorities
• Experience in the design and interpretation of safety studies for regulatory submissions, including INDs and NDAs
• Deep knowledge of FDA and EMA requirements and guidance for nonclinical safety submissions
• Strong communication and interpersonal skills

Nice to have

• 10 years of experience managing and developing a drug safety/toxicology team
• DABT certification

Benefits

• Bonus
• Equity
• Benefits

About the company

Remix Therapeutics focuses on diseases of high unmet medical need through modulation of RNA processing. The company uses a proprietary in-house technology platform to generate discovery programs advancing toward the clinic.