Director - Pks Gh Ta Lead

2+ years

Not Disclosed

India

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 Description: Biopharmaceutics Lead
Location: Hyderabad, India
Company: Novartis
Division: Biomedical Research
Functional Area: Research & Development
Employment Type: Regular, Full-Time

Job Summary:

The Biopharmaceutics Lead is responsible for conducting absorption, distribution, metabolism, and excretion (ADME) research for compounds, drug agents, and metabolites in pre-clinical and clinical development. This role leads the design, execution, and analysis of pharmacokinetic profiles to establish safe and optimal dosage forms for compounds. The individual will oversee bioanalytical research, collaborating with cross-functional teams, and providing critical input into the early development and strategy of new drug candidates.

Major Accountabilities:

Leadership & Strategy:
- Lead cross-disciplinary teams or create functional communities focused on ADME research and pharmacokinetics.
- Serve on leadership teams and decision boards to review projects and provide strategic direction to progress the Division pipeline.
- Foster a culture of continuous improvement and contribute to talent development, succession planning, and attracting top-tier research talent.
Scientific Research & Development:
- Design and conduct studies to evaluate absorption, distribution, metabolism, and elimination (ADME) of drug candidates.
- Lead the development of pharmacokinetic models and simulations to determine optimal dosage regimens and formulations.
- Ensure alignment of experimental methods with scientific and regulatory requirements.
- Contribute to domestic and international drug submissions, preparing documentation to support approval processes.
Collaboration & Mentorship:
- Work closely with toxicology teams to document drug exposure in safety studies.
- Engage with internal and external stakeholders, including regulatory authorities, research partners, and advisory boards.
- Serve as a mentor and role model for talent development within the department and across the organization.
- Drive strategic planning and culture building initiatives within the team and department.
Project & Stakeholder Management:
- Drive critical programs and initiatives within the team and matrix community to advance the Division pipeline.
- Manage external collaborations, ensuring successful and productive partnerships.
- Report technical complaints, adverse events, or special cases related to Novartis products in compliance with regulatory standards.

Key Performance Indicators:

Successful discovery and development of drug candidates.
Implementation of innovative experimental methods.
Timely and effective completion of research programs aligned with Novartis policies and guidelines.
Positive feedback from projects, stakeholders, and cross-functional teams.

Minimum Requirements:

Work Experience:

Strategy Development: Experience in designing and implementing research strategies.
P&L or Unit Accountability: Responsible for managing budgets and resources for research projects.
People Leadership: Proven track record in leading and developing teams.
Collaboration Across Boundaries: Ability to work with multiple teams and functions to drive program success.

Skills:

Expertise in Biopharmaceutics, Clinical Pharmacology, and Drug Development.
Strong knowledge of Clinical Research and Pharmacokinetics.
Ability to work with stakeholders, including regulatory bodies and external research collaborators.
Mentorship and Talent Development skills.
Expertise in Project Management, Quality Control, and Translational Medicine.

Languages:

Proficient in English.

Why Novartis?

Novartis is committed to reimagining medicine to improve and extend the lives of patients. The company fosters an environment of collaboration, support, and innovation, empowering employees to drive breakthroughs that change patients' lives. Join Novartis to contribute to this mission and be part of a global community focused on advancing healthcare.

Benefits & Rewards:

Learn more about the benefits and rewards offered by Novartis in their Life Handbook.

This role provides an exciting opportunity to lead innovative research in the field of drug development, contributing to the discovery of new medicines and the optimization of existing therapies.

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Director - Pks Gh Ta Lead

Job Description

Job Summary:

Major Accountabilities:

Key Performance Indicators:

Minimum Requirements:

Work Experience:

Skills:

Languages:

Why Novartis?

Benefits & Rewards:

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