Group Leader - In-Vitro ADME and In-Vivo PK Studies
Ahmedabad, Gujarāt, IndiaADME
Brief & Role
We are seeking an experienced and motivated Group Leader to oversee our In-Vitro ADME (Absorption, Distribution, Metabolism, and Excretion) and in-vitro PK (Pharmacokinetics) studies. This role is pivotal in our drug development efforts, as it involves managing both in-house in-vitro ADME studies and collaborating with external partners, such as Contract Research Organizations (CROs), for in-vivo PK studies.
- Leadership: Lead and mentor a team of scientists and researchers engaged in in-vitro ADME studies. Provide guidance, set performance expectations, and foster a collaborative and innovative work environment.
- In-Vitro ADME Studies: Oversee the design, execution, and interpretation of in-vitro ADME experiments, including drug metabolism, transport, and drug-drug interaction studies.
- Collaboration with CROs: Establish and maintain relationships with partner CROs for in-vivo PK studies. Coordinate the planning, execution, and monitoring of in-vivo PK studies conducted externally.
- Study Design: Contribute to the design and optimization of in-vitro ADME and in-vivo PK experiments to support drug development projects. Ensure studies are conducted in compliance with regulatory guidelines.
- Data Analysis: Analyze and interpret study data, prepare reports, and present findings to internal teams and external stakeholders.
- Budget Management: Manage the budget for in-vitro ADME studies and collaborate with finance teams to ensure cost-effective execution of in-vivo PK studies conducted at CROs.
- Continuous Improvement: Drive process improvements, implement best practices, and explore new technologies and methodologies to enhance the efficiency and quality of ADME and PK studies.
- Cross-Functional Collaboration: Collaborate closely with other research and development teams to ensure seamless integration of ADME and PK data into drug development projects.
- Client Communication:
- Act as the primary point of contact for clients regarding in-vitro ADME and in-vivo PK studies, ensuring clear and effective communication throughout the project lifecycle.
- Collaborate closely with clients to understand their specific needs, expectations, and timelines.
- Address client inquiries, provide regular progress updates, and manage client feedback and expectations.
- Terms and Conditions (TCs):
- Review and negotiate project-specific terms and conditions with clients, ensuring alignment with the organization's policies and capabilities.
- Collaborate with BD/BD-Ops teams to finalize and execute contracts and agreements.
- Monthly MIS (Management Information System) Reporting:
- Prepare and deliver monthly updates and reports to senior management, summarizing project progress, key milestones, resource allocation, and any potential challenges or deviations from the project plan.
- Provide insights and recommendations to senior management for informed decision-making and strategic planning.
- Ensure that MIS reports are accurate, comprehensive, and aligned with organizational goals.
- Ph.D. in Pharmaceutical Sciences, Pharmacology, or a related field.
- Minimum of 8 years of experience in in-vitro ADME and in-vivo PK studies within the pharmaceutical or biotechnology industry.
- Strong leadership and team management skills.
- Proficiency in designing and conducting in-vitro ADME experiments
- Experience in managing relationships with CROs and overseeing in-vivo PK studies conducted externally.
- Excellent analytical and problem-solving abilities.
- Knowledge of regulatory requirements and compliance in ADME and PK studies.
- Effective communication and presentation skills.
- Detail-oriented and results-driven.
- Ability to work collaboratively in a multidisciplinary environment.
- Excellent interpersonal and client-facing communication skills.
- Experience in contract negotiation and management.
- Proficiency in using MIS tools and software for data analysis and reporting.
- Ability to distill complex technical information into concise and understandable updates for senior management.
- Strong project management skills, including the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
- Commitment to maintaining client confidentiality and upholding the highest ethical standards in all interactions.