PI Health Sciences - Director - Pharmacology (12-15 yrs)

Level: DGM/GM.

Role: Group leader/Sr. Group Leader).

Position Purpose:

- The role shall be responsible for leading the in vitro and in vivo ADME (Absorption, Distribution, Metabolism, and Excretion) studies, ensuring high-quality data generation to support drug discovery and development programs mechanistic ADME studies.

Key Responsibilities:

Strategic:

- Develop and implement a DMPK strategy aligned with the organization's drug discovery and development objectives.

- Establish and grow in vitro and in vivo DMPK capabilities through talent, infrastructure development, and process optimization.

- Collaborate with cross-functional Internal and external stakeholders.

- Act as a Subject Matter Expert (SME) in identifying and resolving technical challenges in ADME and PK studies related to solubility, permeability, metabolism, and liability assessment.

- Foster external collaborations with academia, consortia, and industry partners to stay updated on emerging trends and scientific advancements in DMPK.

Operational:

- Lead the design, execution, and interpretation of in vitro and in vivo ADME studies, ensuring data integrity and adherence to regulatory guidelines.

- Guide junior and peer scientists in best practices for DMPK studies, mechanistic ADME approaches, and multi-property optimization.

- Oversee and troubleshoot technical aspects of studies related to Metabolite Identification (Met ID), metabolic stability, CYP and hERG liability, solubility, and permeability.

- Ensure timely and accurate delivery of data packages for study design, compound selection, and regulatory submissions.

- Utilize PBPK (Physiologically Based Pharmacokinetic) modelling and simulation to predict human PK and optimize clinical translation strategies.

- Maintain and expand knowledge of analytical tools and technologies for data interpretation, ensuring integration of in vitro, in vivo, and in silico ADME insights.

Financial:

- Develop and manage the DMPK department budget, optimizing resources for experimental and operational efficiency.

- Ensure cost-effective allocation of funds for DMPK studies, technology upgrades, and external collaborations.

- Support business development by showcasing DMPK capabilities to potential partners, clients, and regulatory agencies.

People:

- Drive a culture of scientific excellence, innovation, and collaboration within the team.

- Provide training and development programs to enhance technical expertise and leadership capabilities of scientists in ADME/DMPK.

- Foster effective communication within R&D and external stakeholders, ensuring knowledge sharing and cross-functional alignment.

Profile Requirements:

Education:

- Ph. in Pharmaceutical Sciences, Pharmacokinetics, Biochemistry, Drug Metabolism, or a related field.

Previous Experience:

- 12-15 years in the pharmaceutical or preclinical CRO industry with expertise in DMPK.

Industry to be hired from:

- Preferably CRO/CDMO or Pharmaceutical & biotechnology industry.

Functional Competencies:

- Expertise in in vitro and in vivo PK (Pharmacokinetics) methodologies.

- Strong understanding of drug metabolism and ADME principles.

- Proficiency in interpreting PK/PD (Pharmacokinetics/Pharmacodynamics) relationships.

- Experience in PBPK modeling, metabolite identification, and mechanistic ADME.

- Knowledge of analytical tools and regulatory requirements for drug discovery and preclinical studies.

Behavioral and Leadership Competencies:

- Strong leadership skills with the ability to inspire and drive a culture of quality and compliance.

- Considers the impact of decisions on overall quality and compliance.

- Collaborates with other departments, including Research and Development, Manufacturing, and Regulatory Affairs, to ensure a unified approach to quality.

- Excellent communication and interpersonal skills