Director Group lead Immunology, PK Sciences (80-100)

Basel - Switzerland

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Band

Level 6

Job Description Summary

Welcome to where we thrive together! Are you ready to join a community where you can make a real impact on the world by supporting the global pipeline of the Immunology TA across all phases of development At Novartis we believe in creating a positive and inclusive work environment where we can solve the toughest healthcare challenges together.

Job Description

Location: Basel Switzerland

This role is based in Basel Switzerland. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key responsibilities:

Accountable for development and implementation of the PKS strategy for a portfolio of program(s) and coordinates pharmacokinetic / drug metabolism/ modelling and simulation related elements for pre-clinical and/or clinical projects. Identifies potential project hurdles contributes to dose selections and provides solutions and establishes contingency plans. Represents PKS on IMM project teams(s).
Responsible for supervising training and mentoring PKS PTM and to ensure line function excellence with respect to efficiency and scientific / technical project support.
Participates and contributes internal strategy Boards and review committees dealing with projects assigned to direct reports
Responsible for resource planning management and administration (FTEs and direct costs)
Reviews study protocols internal strategy documents and HA related documents for projects assigned to direct reports
Proactively contributes expert pharmacokinetic /drug metabolism pre-clinical and clinical pharmacology input into key pre-clinical and clinical and regulatory documents including clinical study protocols clinical study reports investigator brochures IND / IMPDs and NDA/BLAs within agreed timelines and addresses all regulatory requirements with minimal supervision. Provides input to key NIBR GDD milestones (DC IDPA ISA TDP etc).
Responsible for the PK PK/PD IG and M&S component of study protocols reports project summaries and development plans within agreed timelines and which meet regulatory requirements. Prepare appropriate responses to Health Authority questions (globally).
Oversees or performs PK and PK/PD analyses using a variety of tools and approaches. Integrates interprets and reports data to project teams and other customers. Support project teams with modeling- and simulation-based input to clinical trial design evaluations integrated analysis and reporting.
Monitors study timelines objectives and budgets ensure accuracy of project progress in company tracking tools. Assures rapid and effective communication of data to project teams.
Leads PKS sub-teams. Coordinates with appropriate sub-team members and ensures implantation of project strategy and/or prepares summary documentation.

Essential Requirements:

PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic background.
Relevant TA/DA experience and demonstrated track record on coaching and mentoring of associates would be preferred
Minimum 8-10 years in drug development functions (e.g. DMPK Clinical Pharmacology) with a minimum of 5 years experience within a relevant LF in industry academia or regulatory agency
Extensive and in-depth knowledge of drug metabolism and pharmacokinetics including pharmacology PK and PK/PD evaluation immunogenicity assessments and regulatory requirements.
Demonstrated success leading and influencing in a multi-disciplinary environment including global project teams. Aware of the most recent developments in drug development sciences and the implications for current projects.
Strong coaching mentoring and people management skills

Desirable Requirements:

Proven record as team player/leader with excellent influencing & negotiation skills.
Excellent organizational and project skills

Commitment to Diversity and Inclusion / EEO paragraph:

Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart passionate people like you. Collaborating supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: Desired

Accountability Biopharmaceutics Chemistry Clinical Pharmacology Clinical Research Clinical Trials Critical Capabilities Drug Development Drug Discovery Due Diligence Electronic Components Lifesciences Mentorship Non-Disclosure Agreements Patient Care Physics Quality Control Scheduler Stakeholders Management Translational Medicine Waterfall Model Well-Being

Required Experience:

Director

BandLevel 6Job Description SummaryWelcome to where we thrive together! Are you ready to join a community where you can make a real impact on the world by supporting the global pipeline of the Immunology TA across all phases of development At Novartis we believe in creating a positive and inclusive w...