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 inclusion.switzerland@novartis.com 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? https://www.novartis.com/about/strategy/people-and-culture

Join 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: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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? https://www.novartis.com/about/strategy/people-and-culture

Join 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: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards