United States onlyWho You Are
The Vice President of Toxicology will oversee the design and execution of nonclinical safety programs to support the development of drug candidates from discovery through market authorization. This role will manage a portfolio of pre-clinical toxicology projects in gene therapy and provide matrixed leadership / mentorship to the nonclinical team.
How You Contribute
- Responsible for ensuring the portfolio-wide toxicology programs are aligned with global regulatory expectations
- Deep understanding of GLPs, ICH guidance, and global regulatory requirements
- Experienced in developing and operationalizing nonclinical strategy
- Experienced in pharmacology/toxicology protocol development
- Experienced in both gene therapy and small molecule drug development
- Lead the preparation, authoring of nonclinical packages for CTAs and INDs
- Serve as nonclinical representative on development programs
- Present or participate in regulatory interactions
- Work effectively with consultants to ensure input is addressed
What You Bring to the Team
Education & Experience
- PhD, DABT
- 10+ years experience in investigational drug development
- Expertise/deep knowledge in ophthalmology, immunology, or neurology preferred
- Demonstrated leadership skills
Competencies
- Outstanding collaboration skills required, as this is an extensive matrix role crossing both internal and external stakeholder management. Strong interpersonal, organizational, and multi-tasking skills are must.
- Advanced written and oral communication skills. Specifically, in drafting and review of regulatory documents. This individual will be required to represent the company at all levels of stakeholder engagement, internal and external.
- Deep understanding of GLP requirements
- Strong track record of driving excellence within an organization
- Experience working in cross-functional teams and leading nonclinical and bioanalytical functional areas.
- Leading strong working relationships with key partners to advance products through development.
- Knowledge of product development and life cycle management concepts and interdependencies within the overall development process
Working Conditions and Physical Demands
- Work is normally performed: at a desk
- Lifting requirements: None
- Travel requirements: Occasional
About Kriya
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
What We Offer
Medical, Dental and Vision with 100% employee premium coverage ∙ Retirement matching ∙ Short and long-term disability benefits ∙ 12 company paid holidays ∙ Generous Time Off ∙ Cyber Safety protection ∙ EAP ∙ Company paid life insurance ∙ Equity ∙ and more!
Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.
