Senior Manager, Clinical Pharmacology

Kriya Therapeutics

Research Triangle Park, NC

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JOB DETAILS
LOCATION
Research Triangle Park, NC
POSTED
23 days ago

Description


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.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

Role Overview


The Clinical Pharmacologist 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. This role requires the ability to work across a variety of therapeutic indications and data types. This position will represent the Clinical Pharmacology function on development teams and collaborate with other disciplines, including clinical development, biostatistics, regulatory, and more, to ensure consistent contributions across therapeutic areas.

Key Responsibilities
  • 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 and Work Environment


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.

Work Environment
  • Primarily desk-based, generally in an office or home office setting
  • May involve extended periods of sitting and computer use. 

Life at Kriya


Discover True Collaborative Teamwork
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.

We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.

Rewards & Benefits
  • Time Off & Work-Life Balance:Flexible Time Off Paid Parental & Medical Leave Paid Company Holidays
  • Health & Wellness:  Fertility & Family Building Benefits Medical, Dental, and Vision Insurance Employee Assistance Program (EAP) Life Insurance Short- and Long-Term Disability Coverage
  • Financial Security: Equity 401(k) with Company Match Identity Theft Protection
  • And More!

About the Company

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Kriya Therapeutics