Senior Investigator - Pharmacokinetics

0-5 years

Not Disclosed

Hyderabad

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

Join Our Network: If this role is not suitable for your experience or career goals, but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Network.

Apply Now: Ready to create a brighter future together? Learn more about Novartis and explore career opportunities at Novartis Careers.

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.

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