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Senior Investigator - Pharmacokinetics

0-5 years
Not Disclosed
12 May 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Title: Associate Director / Senior Principal Scientist

Position Purpose: The Associate Director / Senior Principal Scientist is responsible for designing and conducting absorption, distribution, metabolism, and excretion (ADME) research on compounds, drug agents, and metabolites in pre-clinical and/or clinical development. This role involves compiling pharmacokinetic profiles, determining safe dosage forms, developing protocols, preparing study documentation, and supporting domestic and international drug submissions.

Responsibilities:

  • ADME Research: Conduct research on absorption, distribution, metabolism, and excretion of drugs in animals and humans for therapeutic areas, product lines, or programs.
  • Pharmacokinetics: Compile data such as absorption and excretion rates to establish pharmacokinetic profiles and optimal dosage rates.
  • Safety Studies: Collaborate with toxicology to document drug exposure in safety studies.
  • Bioanalytical Research: Manage bioanalytical studies on drug agents and metabolites in clinical studies, including coordination with external labs.
  • Report Writing: Develop and review safety reports, protocols, and study documentation for regulatory submissions.
  • Strategic Leadership (Associate Director): Provide strategic and broad team leadership on drug discovery and/or early development projects. Assess the impact and value of scientific activities to define team objectives and advance projects.
  • Innovative Projects (Senior Principal Scientist): Establish and lead novel projects in emerging scientific/technical areas. Develop ideas with team members, collaborate across therapeutic areas, and lead teams to enable project progression.
  • Cross-functional Collaboration: Serve as a liaison with marketing, conduct analytical and kinetic studies, and connect team efforts with broader strategic priorities.
  • Process Improvement: Implement and promote efficient, quality processes to meet timelines and deliverables. Ensure compliance with regulatory requirements.

Minimum Requirements:

  • Skills & Experience:
    • Excellent computer skills including proficiency in Word, Excel, and document management systems
    • Experience in document editing, formatting, and quality documentation practices
    • Strong communication skills with fluency in English (written and oral)
    • Prior experience in the Pharmaceutical Industry
    • Ability to prioritize and manage multiple demands and projects
    • Good presentation skills for imparting technical training
  • Qualifications:
    • Chemistry, Clinical Pharmacology, Clinical Research, and Clinical Trials expertise
    • Experience in Drug Discovery, Due Diligence, Gene Therapy, Medical Research, and Translational Medicine
    • Proficiency in Microsoft Office, Modeling and Simulation, and Project Management

Why Novartis:

  • Impact: 769 million lives were touched by Novartis medicines in 2020. We strive to improve and extend people's lives through innovative science and digital innovation.
  • Culture: Thrive in an inclusive environment that inspires new ways of working. Collaborate with courage to tackle the world's toughest medical challenges.
  • Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representing the patients and communities we serve.

Location: Hyderabad, India

Division: Biomedical Research

Business Unit: Pharma Research

Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area: Research & Development

Job Type: Full-time

Employment Type: Regular

Shift Work: No

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Equal Opportunity Employer: Novartis is committed to providing equal employment opportunities without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, or any other protected class.

Contact: For more information about the role, please visit our careers page.