Manager, Clinical Development – PBPK

Azurity Pharmaceuticals; Hyderabad; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Azurity Pharmaceuticals is seeking a skilled PBPK modeling expert to contribute to early-phase clinical programs and translational work. You will specialize in physiology-based PK modeling and work within the Clinical Development team to support drug products from design through IND planning.

You will run non-compartmental PK analyses and build PBPK models to inform formulation decisions, sampling plans, and translational strategies, while coordinating with CROs and program managers to ensure

Qualifications

• Minimum 5+ years in drug development with 3+ years in early phase clinical development and modeling & simulation experience.
• Regulatory guidelines in model-informed drug development (ICH GCP) awareness.
• Experience with 505.b.2 drug development is preferable.

Responsibilities

• Perform non-compartmental PK analysis to guide study design, understand product behavior and parameter estimates.
• Develop PBPK models to guide formulation development and target dissolution profiles.
• Run simulations with PBPK/PK models to guide sampling and study design in translational studies.
• Effectively communicate and present study results internally and externally.
• Oversee external PBPK/PK-related work and guide CROs as needed.
• Attend portfolio team meetings and collaborate with program managers to align study plans with development timelines.
• Oversee study initiation, monitoring and closeout and maintain communication with external partners.
• Contribute to development, review, and approval of clinical documents like pre-IND, IND, study plans.

Skills

PBPK Modeling

Non-compartmental PK analysis

Model-informed drug development

Cross-functional collaboration

Regulatory knowledge

Education

M.Pharm/Pharm.D/Ph.D in pharmaceutics or pharmacology

Tools

PK-Sim

GastroPlus

Winnonlin

Job description

Azurity Pharmaceuticals is a privately held specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late‑stage pipeline. The company’s patient‑centric products span the cardiovascular, neurology, endocrinology, gastro‑intestinal, institutional, and orphan markets and have benefited millions of patients. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer.

About The Role

The role is part of the Clinical Development team. It requires specialization in physiology‑based pharmacokinetic (PBPK) modeling and will contribute to early‑phase clinical programs for developing and evaluating drug products and translational preclinical work.

Key Responsibilities

• Can independently perform non-compartmental PK analysis to guide study design elements, understand product behavior and utilize parameter estimates for model building.
• Can meta-analyze literature searches, discover the patterns and establish PBPK models guiding formulation development, target dissolution profiles, build IVIVC/R.
• Run simulations with the PBPK/PK models to guide sampling matrix, sample collection and study designing in translational studies.
• Effectively communicate and present the study results internally and externally.
• Able to oversee and review external PBPK/PK-related works and guide wherever necessary.
• Attend portfolio team meetings and collaborate with respective program managers to develop study plans and ensure alignment with overall development plan and timelines.
• Partly oversee study oversight including study initiation, monitoring and study closeout and routine follow-up and communication with external partners (CROs).
• Contribute to the development, review, and approval of clinical documents like pre-IND, IND, clinical modules, protocols, investigator’s brochure, study plans etc.

Required Skills And Experience

• Minimum of 5+ years in drug development with at least 3 years in early phase clinical development with hands‑on modeling & simulation experience preferred.
• Sound understanding of regulatory guidelines in model informed drug development and clinical requirements, ICH GCP is required.
• Work experience in 505.b.2 drug development is preferable.
• Working knowledge of biostatistics and pharmacokinetics.
• Have proven track record of working with PK-Sim, GastroPlus, Winnonlin or other PK software.
• Strong organizational, interpersonal and both verbal and written communication skills with ability to work as a member of a cross‑functional team.

Preferred Qualifications

• M.Pharm/ Pharm.D/ Ph.D preferred in the field of pharmaceutics, pharmacoinformatic or pharmacology.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.