Job ID279424BRPosition TitleDirector, Biologics, clinical PK Sciences (80-100%)Apply to Job
Job Description
48! That’s the number of projects we support in the Therapeutic Area of Autoimmune, Transplantation and Inflammation (ATI) within the PK Sciences department of Translational Medicine.
The PK Sciences group provides PK and PKPD strategies from early discovery all the way through to registration and beyond: about half of this portfolio represents biologics projects from classical monoclonal antibodies to complex biologics constructs. You will be a senior Project Team Member bringing your biologics subject matter expertise, strategic and scientific project / people leadership across our extensive ATI portfolio and drive biologics projects within PK Sciences.
• provide clinical pharmacology / PK expertise for across all development phases
• represent PK Sciences on cross-functional teams and influence design, execution and analysis of PK, PKPD and clinical pharmacology related study components
Your responsibilities include:
• Design the PK and PKPD strategy for your programs and coordinate PK related elements for preclinical and/or clinical projects: identify potential project hurdles, provide solutions, and establish contingency plans.
• Represent PK Science on Global Program Teams or early project teams and lead a sub-team of PK Science Line Function experts, and prepare summary documentation. Ensure constructive collaboration within drug development teams (GPTs, etc.) and with other internal partners (e.g. Pharmacometrics, Technical Development, etc )
• Lead contributor to provide PK Science input into key preclinical, clinical and regulatory documents including clinical study protocols, clinical study reports, IBs, IND / IMPDs and NDA/BLAs within timelines, and address all regulatory requirements in consultation with colleagues. Prepare appropriate responses to Health Authority questions globally
• Oversee or perform PK and PK/PD analyses using a variety of tools and approaches. Integrate, interpret and report data to project teams and other customers
• Monitor study timelines, objectives and budgets, ensure accuracy of project progress in company tracking tools (e.g. Succeed). Assure rapid and effective communication of data to project teams. Ensure compliance with legal requirements and corporate guidelines (applicable GLP/non-GLP, GCP requirements)
• Represent the department in meetings with external parties including Investigators, external Key Opinion Leaders, and Health Authorities
• Evaluate in-licensing opportunities and carry out Due Diligence activities
• Share your expertise through coaching and mentoring peers and maintain and enhance your technical and drug development expertise
ABOUT NIBR TRANSLATIONAL MEDICINE & PK SCIENCES:
NIBR’s global Translational Medicine group builds on basic research advances to develop new therapies that address unmet medical need. We are the crucial bridge between drug discovery and clinical application. Through our work, we increase the speed, quality and productivity of drug discovery and development by Novartis and play a pivotal role in bringing innovative medicines to patients
PK Sciences’ mission is to provide and oversee scientifically robust compound progression strategies by optimizing pharmacology, biopharmaceutics, pharmacokinetics, and pharmacodynamics for the rapid advancement of medical treatments and therapies from
research through post-approval. The vision is to be the industry standard for integration of ADME, DMPK and preclinical Modeling across research and development
Minimum requirements
WHAT YOU’LL BRING TO THE ROLE:
• Ph.D. in pharmacokinetics, drug metabolism or a related discipline; additional postdoc preferred
• Significant (e.g. 10 years+) directly relevant clinical pharmacology / PK project experience within international Pharmaceutical environments. Your career shows evidence of increasing levels of responsibility
• Biologics Subject Matter Expert with a track record of quality publications and involvement in professional societies - and having translated that expertise into successful working within cross-functional teams in highly dynamic, matrixed, project team environments. You are used to bringing scientific leadership and mentoring to project team members, colleagues, internal and external stakeholders. You thoroughly understand the industry landscape, PK project and Health Authority expectations
• Integrated knowledge of related disciplines (i.e. PK, toxicology, regulatory) and the drug discovery and development process
• Demonstrated expertise using in silico analysis tools (e.g. WinNonlin, Phoenix, GastroPlus, SymCyp)
• Advanced / business-level oral and written English
Approach and working style
We want an authentic you. Here are some traits we think are important in this position
• Strategic thinker with advanced stakeholder management: you have strong communication skills (verbal, written and presentation) and have influence because of your ability to clearly present complex issues and straightforward solutions
• Excellent interpersonal skills: used to successfully developing effective, collaborative, diverse internal and external relationships, you influence across different nationalities, ethnicities, languages and thinking styles
• A pragmatic, thoughtful, curious, innovative and entrepreneurial approach, used to successfully managing ambiguity with resilience and enthusiasm, responding constructively to challenging new ideas and input
WHY CONSIDER NOVARTIS?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine.DivisionNIBRBusiness UnitTranslational MedicineLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularShift WorkNo
