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Associate Director - Pks Drug Disposition, Hyd

10+ years
Not Disclosed
10 Dec. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Associate Director - PKS Drug Disposition
Location: Hyderabad, India
Job ID: REQ-10034036
Date: Dec 13, 2024

Job Summary:

The Associate Director - PKS Drug Disposition will lead and manage the PKS Drug Disposition team at Novartis Hyderabad. This position involves collaborating with local and global stakeholders, including Clinical BA teams and CROs, to support the drug discovery portfolio. The role ensures alignment with Novartis Values and Behaviors and contributes to drug discovery and development efforts.

Major Accountabilities:

  • Team Management: Lead and manage the PKS Drug Disposition team in Hyderabad in a matrixed structure, fostering a culture of collaboration, innovation, and leadership.
  • PKS Strategy: Participate in PKS sub-teams to define strategy for compound progression and development.
  • Project Management: Oversee study timelines, objectives, and budgets; ensure timely and accurate project progress reporting.
  • Communication: Provide clear, effective communication of data, strategy, and results to project teams.
  • Data Analysis: Contribute to the analysis of PK/TK, PKPD data and present results to the program.
  • Problem Solving: Proactively identify potential project hurdles, offer solutions, and implement contingency plans.
  • Documentation: Independently author key pre-clinical/clinical/regulatory documents such as study protocols, study reports, modelling reports, investigator brochures, IND/IMPDs, and NDAs.
  • Cross-Departmental Leadership: Lead cross-departmental initiatives and teams to support drug discovery efforts.
  • External Relationships: Represent PKS at the business level, overseeing governance and external relationships.
  • Training & Mentorship: Mentor and train PKS associates, ensuring continuous development.

Job Dimensions:

  • Number of Associates: 10-15 direct reports
  • Financial Responsibility: None
  • Internal Impact: Enabling drug discovery
  • External Impact: Operational excellence in execution

Ideal Background:

Education:

  • PhD in life sciences or healthcare

Experience:

  • 10+ years of experience in the pharmaceutical industry, with at least 10 years in drug discovery or drug metabolism and pharmacokinetics (DMPK).
  • Extensive knowledge of pharmacokinetics (PK), pharmacodynamics (PK/PD), and drug metabolism.
  • Proven success in leading cross-functional global teams.
  • Deep understanding of regulatory requirements and experience with regulatory authorities.
  • Expertise in drug design, development tools, and laboratory procedures.

Skills:

  • Strong scientific publications and external presentations record.
  • Knowledge of research tools, problem-solving techniques, and research methodologies.

Why Novartis?

Novartis offers a collaborative and dynamic environment focused on improving the lives of patients. The company supports diverse teams, promotes a culture of inclusion, and provides opportunities for personal and professional growth. Join Novartis to be a part of transformative work that makes a real difference.