Sr. Manager, Clinical Pharmacology

Kriya Therapeutics, Inc. is seeking a Sr. Manager, Clinical Pharmacology to advance their pipeline by implementing pioneering clinical pharmacology and Model-Informed Drug Development approaches.

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.

Role Overview

The Senior Manager, Clinical Pharmacology, will play a vital role in advancing Kriya’s pipeline by implementing pioneering clinical pharmacology and Model-Informed Drug Development approaches. You will primarily be responsible for supporting quantitative decision-making in product life cycle by implementing population PK, PK/PD, exposure-response modelling and simulation to support drug development.

• Offer scientific and strategic input into Therapeutic Area clinical pharmacology plans.
• Identify, develop, and carry out strategic clinical pharmacology activities.
• Assist in the development and validation of pharmacometrics models.
• Oversee CRO collaboration on clinical pharmacology projects
• Conduct population pharmacokinetic and pharmacodynamic analyses.
• Provide pharmacometrics expertise to project teams.
• Collaborate with cross-functional teams to support the design and execution of clinical studies (early and late phase trials).
• Lead the development of the clinical pharmacology sections of clinical protocols and associated analysis plans
• Prepare relevant sections and review regulatory submissions.
• Collaborate with academic institutions and key opinion leaders
• Stay current with scientific literature and regulatory guidance

Experience & Skills

• PhD degree (in pharmacometrics, pharmaceutical sciences, or related field) preferred or equivalent relevant experience.
• 4+ years of progressive experience.
• Minimum of 4 years of experience in PK/PD modelling, preferably in biologics.
• An equivalent combination of education and experience is acceptable
• Strong knowledge of pharmacokinetics and pharmacodynamics.
• Experience with population PK/PD modeling and simulation.
• Experience with NONMEM, R, or other pharmacometrics software.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Prior experience of regulatory filings and knowledge of regulatory compliance processes specific to clinical pharmacology is preferred.

Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.