Director, Clinical Pharmacology

Company Summary:

Kriya is a next generation gene therapy company focused on expanding the field to new frontiers. We have built a fully integrated, technology-enabled platform for rational vector design, analytical characterization, and scalable manufacturing to design and develop gene therapies for diseases with well-understood underlying biology. We believe that rationally engineered gene therapies can transform the treatment of a broad universe of diseases – and we are prepared to lead this revolution in medicine.

Our team is made up of leading scientific experts who are passionate about improving patients’ lives and easing the burden of these life-changing disorders for patients. We are looking for teammates with the ambition, creativity, and energy to help us build a unique organization.

If you are looking to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, Kriya is the company for you.

Position Summary:

The Director of Clinical Pharmacology is responsible for supporting quantitative decision-making in drug development through the development and application of PK/PD, quantitative systems pharmacology, population PK, exposure-response, and other models. The Director of Clinical Pharmacology is expected to possess strategic leadership skills and have a deep understanding of clinical pharmacology principles and overall biologic development processes and strategies for high profile, complex, or novel development programs. Experience and knowledge of one or more of Kriya’s disease focus areas is critical to being able to influence cross-functional discussions with product development teams and relevant stakeholders.

Primary Responsibilities:

• Leads the development and implementation of fit-for-purpose modeling approaches leveraging, e.g., target-mediated drug disposition models
• Oversee external vendor and CRO partner activates for clinical pharmacology-related activities
• Conduct quality control activities on model codes and reports from external vendors
• Provide strategic advice on clinical pharmacology trials (e.g., clinical trial design) and overall early phase drug development activities
• Serve as the single point of contact as a clinical pharmacology representative on product development teams
• Develop statistical and PK analysis plans and produce standalone PK/PD reports that can be appended to toxicology or clinical study reports
• Monitor changes in the regulatory environment, both general and specific to the therapeutic area, and support and advise product development teams accordingly
• Provide clinical pharmacology leadership as needed in product in-license/due diligence review, product divestment, and product withdrawal
• Participate in skill-development, coaching, and performance feedback of other clinical pharmacologists working on the product/project
• Maintain up-to-date training on cGLP regulations and appropriate SOPs

Required Qualifications:

• PhD, MD, PharmD, or MD PhD degree in a science-related field 
• Experience in relevant therapy area (AAV gene therapy) is preferred
• 5+ years of industry/consulting experience in R&D, pre-clinical, and clinical environments
• Solid experience in pharmacometrics, clinical pharmacology, pharmacokinetics, or a related discipline in a project team setting is preferred
• Expertise in PK/PD modeling with strong quantitative skills applied to develop models with nonlinear behavior, mechanistic or semi-mechanistic components relating to mechanism of action, and tailored to meet specific drug-development questions
• Proficiency in PK/PD and statistical software (e.g., NONMEM, R)
• Experience moving compounds through the clinical trials process and experience with various elements of clinical development, trial design and management, and filings preferred
• Independent performance of analysis, modeling, and report development with limited supervision
• Ability to work strategically within a complex, business-critical, and high-profile development program
• Must demonstrate competencies in strategic thinking, strategic influencing, innovation, initiative, leadership, and excellent oral and written communication skills

We celebrate diversity and are committed to creating an inclusive environment for all employees