Manager, Clinical Development – PBPK

Azurity Pharmaceuticals - US; Hyderabad; On-site; INR 2,000,000 - 4,000,000; Full time

Job summary

Azurity Pharmaceuticals, a leading specialty pharmaceutical company, is seeking an experienced PBPK Modeling Scientist to contribute to early-phase clinical programs and translational work. You will perform non‑compartmental PK analyses, build PBPK models, and guide study design with cross‑functional teams within a dynamic R&D setting.

The role requires 5+ years in drug development with hands-on modeling, familiarity with PK software, and a strong grasp of regulatory expectations.

Qualifications

• Minimum 5+ years in drug development with at least 3 years in early phase clinical development and hands-on modeling & simulation experience.
• Sound understanding of regulatory guidelines in model informed drug development and clinical requirements, ICH GCP is required.
• Experience with 505.b.2 drug development is preferable.

Responsibilities

• Independently perform non-compartmental PK analysis to guide study design and model building.
• Meta-analyze literature to develop PBPK models guiding formulation development and IVIVC.
• Run simulations with PBPK/PK models to guide sampling matrices and study design in translational studies.
• Communicate and present study results effectively to internal and external stakeholders.
• Oversee external PBPK/PK-related work and guide CROs as needed.
• Collaborate with program managers to develop study plans aligned with development timelines.
• Oversee study initiation, monitoring, and closeout and maintain communication with external partners.
• Contribute to development, review, and approval of clinical documents (pre-IND, IND, protocols, etc.).

Skills

PBPK modeling

Non-compartmental PK analysis

Regulatory guidelines understanding

ICH GCP knowledge

PK software proficiency

Cross-functional collaboration

Education

M.Pharm/Pharm.D/Ph.D

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. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity’s success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

About the Role:

As part of the Clinical Development team at Azurity, the role requires specialization in physiology-based pharmacokinetic (PBPK) modeling who can contribute to early phase clinical programs for developing and evaluating drug products and translational preclinical works.

In this role, the candidate will report to the Director, Clinical Development and work with stakeholders and team members to provide scientific excellence, build effective relationships across R&D, and ensure optimal design and analysis of clinical investigations.

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.