Sr. Manager, Clinical Pharmacology

Kriya Therapeutics Inc • Morrisville, NC

112d

About The Position

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. 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.

Requirements

• 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.
• 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.

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.

Benefits

• Medical, Dental and Vision
• 401(k) with Company Match
• Short and Long-term Disability Benefits
• Company Paid Holidays
• Flexible Time Off
• Cyber Safety protection
• EAP
• Life Insurance
• Equity
• and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree