Manager, Clinical Development – PBPK

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.