Associate Director - Pks Drug Disposition, Hyd

10+ years

Not Disclosed

India

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: PKS Drug Disposition Unit Manager
Location: Hyderabad, India
Company: Novartis
Division: Biomedical Research
Functional Area: Research & Development
Employment Type: Full-time, Regular

Job Summary:

The PKS Drug Disposition Unit Manager will lead the team at Novartis Hyderabad, driving the PKS strategy for compound progression, development, and analysis. This role involves collaborating with local CROs, managing study timelines and budgets, and ensuring clear communication of project data and results. The manager will also mentor and train junior team members and represent PKS at the business level.

Key Responsibilities:

Team Management:
- Lead and manage the PKS Drug Disposition team in Hyderabad, fostering a culture of innovation, collaboration, and leadership.
- Collaborate with line function managers for matrix leadership and create a positive, unbossed work environment.
Strategic Contribution:
- Participate in PKS sub-teams to define strategies for compound progression.
- Ensure alignment with cross-functional teams and leadership, and manage the execution of strategies.
Project Management:
- Oversee study timelines, objectives, and budgets, ensuring progress is tracked accurately in company tools.
- Communicate data and results effectively to project teams, ensuring transparency and alignment on strategy.
Data Analysis & Reporting:
- Contribute to the analysis and interpretation of PK/TK, PKPD data during all stages of discovery and development.
- Independently author key documents such as clinical protocols, clinical study reports, regulatory submissions, and modelling reports.
Cross-Departmental Leadership:
- Lead cross-functional teams, initiatives, and work streams to ensure effective collaboration.
- Provide PK Sciences expertise in due diligence activities and prepare appropriate documentation.
External Relations & Publications:
- Act as an external representative for PKS, particularly in governance and oversight roles.
- Publish internally and externally to enhance Novartis' visibility in the PK Sciences community.
Mentoring & Training:
- Mentor and train junior PK Science associates, ensuring they meet organizational requirements.
- Support the growth of a high-performing team and ensure adherence to organizational SOPs and GxP guidelines.

Key Performance Indicators:

Timely and effective execution of studies and projects in alignment with organizational goals.
High-quality documentation and regulatory submissions.
Positive feedback from internal stakeholders and successful collaboration with external partners.

Ideal Candidate Background:

Education & Qualifications:

PhD in life sciences or healthcare-related field.
Fluent in oral and written English.

Experience:

10+ years in the pharmaceutical industry, with at least 10 years of experience in drug discovery, development, or related fields (e.g., Drug Metabolism and Pharmacokinetics).
Extensive knowledge in drug metabolism, pharmacokinetics, and pharmacodynamics.
Proven success in working in cross-functional global teams, with a solid understanding of drug development sciences.
Experience dealing with regulatory authorities and managing due diligence activities.
Solid track record of scientific publications and external presentations.

Skills:

Strong management and leadership skills, with the ability to mentor and train others.
In-depth knowledge of techniques and tools used in drug design and development.
Ability to manage complex projects and work independently in a dynamic environment.
Expertise in regulatory requirements, GxP guidelines, and industry best practices.

Why Novartis?

Novartis is dedicated to discovering innovative medicines for unmet medical needs. As a part of Novartis, you will contribute to transformative breakthroughs in healthcare while working in a dynamic, collaborative environment. The company offers a supportive culture focused on developing talent and fostering career growth.

Benefits & Rewards:

Learn more about Novartis benefits and rewards at Novartis Benefits.

This role provides a unique opportunity to lead and shape the future of drug disposition and pharmacokinetics at Novartis, while collaborating with global teams and driving high-impact research.

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Associate Director - Pks Drug Disposition, Hyd

Job Description

Job Summary:

Key Responsibilities:

Key Performance Indicators:

Ideal Candidate Background:

Education & Qualifications:

Experience:

Skills:

Why Novartis?

Benefits & Rewards:

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