Represent Preclinical Safety Translational Medicine group as a Safety Assessment Expert, collaborating across cross-functional project teams to identify and mitigate key project issues related to preclinical safety and assuring appropriate design and execution of nonclinical safety assessment plans for projects.
This role is advertised for Basel Switzerland but can also be for Cambridge MA, USA: please state in your application letter if you would like to be considered for both locations. International family relocation is supported.
Level: Associate Director, or Director for candidates with suitably strong profiles
Your responsibilities will include:
• Represent PCS on Novartis Institutes for BioMedical Research and Global Drug Development project teams and provide expert nonclinical safety input to key NIBR and Development milestone presentations / documents in a timely manner. Identify potential project hurdles, provide solutions and establish contingency plans as necessary
• Lead the development of detailed, integrated, scientifically relevant and compliant nonclinical safety assessment plans to support development / registration of drugs of various modalities
• Timely communication to Preclinical Safety Therapeutic Area Head, target team and project team regarding theoretical or observed safety effects; their impact and proposed plans to address them; resource requirements to execute nonclinical safety plan
• Proactively contribute expert safety pharmacology and toxicology input into key preclinical, clinical, and regulatory documents including Investigator brochures, IND/CTAs, Health Authority briefing books and NDA/BLAs, and addresses all regulatory requirements with minimal supervision
• Clear, concise and accurate communication of nonclinical safety results and their impact to Health Authorities and investigators. Prepare appropriate responses to all Health Authority questions
• Ensure accuracy of preclinical safety study plans and progress in company tracking tools. Assure rapid and effective communication of data to project teams
• Lead Preclinical Safety target teams and work closely with your Therapeutic Area Head for strategic alignment
• Evaluate in-licensing opportunities, carry out Due Diligence activities, and coach other Preclinical Safety associates in Due Diligence activities
• Attend meetings with external parties including independent experts and Health Authorities
• Maintain and enhance technical and drug development expertise e.g. through training courses and external meeting attendance
• Coach and mentor other PCS associates
• Publish internally and/or externally as main contributor; review current literature in own discipline and related areas and proactively share with others
• Adhere in strict accord to SOP, GLP and other guidelines
Safety Assessment Expert, Preclinical Safety (80-100%)
• PhD in a biological or chemical science e.g. pharmacology, toxicology, immunology, biochemistry, or MD / DVM / PharmD with appropriate training and work experience
• Business-level English, oral and written
• Minimum 8 years in drug development within a relevant line function in industry or regulatory agency
• Minimum of 5 years as a toxicology project team member in the preclinical development of small molecules, biotherapeutics and/or gene and cell therapies
• Demonstrated experience in preclinical safety issue resolution, successful communication and negotiation with global Health Authorities
• Demonstrated understanding of regulatory submission components for registration (CTD) including mastery in authoring submission components in Documentum-like system
• IND/CTA submission experience. BLA/NDA/MAA submission experience highly desirable
• Knowledge of regulatory requirements
• Demonstrated success leading and influencing in cross-industry organizations (discipline-related or related to drug development) is highly desirable
• Proven record as a team member/leader with excellent negotiation skills
• Excellent organizational and project skills
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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 brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network: https://talentnetwork.novartis.com/network
Research & Development
Novartis Pharma AG