OverviewDirector Group lead Immunology, PK Sciences (80-100%).2 days ago Be among the first 25 applicantsSummary: 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.About The RoleLocation: Basel, SwitzerlandThis 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 ResponsibilitiesAccountable 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 to 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 implementation of project strategy and/or prepares summary documentation.Essential RequirementsPhD / 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 preferredMinimum 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 agencyExtensive 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 skillsDesirable RequirementsProven record as team player/leader with excellent influencing & negotiation skills.Excellent organizational and project skillsCommitment To Diversity And Inclusion / EEONovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Accessibility And AccommodationNovartis 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?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/networkBenefits 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
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