Manager, Clinical Development – PBPK

RXinsider LTD.; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Azurity Pharmaceuticals is seeking a Senior PBPK Modeling Scientist to lead physiology-based pharmacokinetic analyses within the Clinical Development team in Hyderabad. The role focuses on supporting early-phase programs, translating translational work into study designs, and ensuring robust PK/PD analyses.

The candidate will report to the Director of Clinical Development and collaborate across R&D, providing scientific excellence and reliable modeling to guide program decisions and regulatory

Qualifications

• Minimum 5+ years in drug development with at least 3 years in early phase clinical development.
• Hands-on modeling and simulation experience required.
• Familiarity with regulatory guidelines for model-informed drug development and ICH GCP.
• Experience with 505(b)(2) drug development is preferable.
• Strong knowledge of biostatistics and pharmacokinetics.
• Proven ability to work with PK software such as PK-Sim, GastroPlus and WinNonlin.

Responsibilities

• Independently perform non-compartmental PK analyses to guide study design.
• Meta-analyze literature to inform PBPK models for formulation development.
• Run PBPK/PK simulations to guide sampling and study design in translational studies.
• Communicate results to internal and external stakeholders.
• Oversee external PBPK/PK-related work and provide guidance as needed.
• Collaborate with program managers to align study plans with development timelines.
• Oversee study oversight including initiation, monitoring and CRO communications.
• Contribute to clinical documents like pre-IND, IND, and study protocols.

Skills

PBPK modeling

Non-compartmental PK

Study design

Communication skills

Cross-functional teamwork

Education

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