Director, Therapeutic Area Biomarker Lead (Neuroscience)

Novartis Pharma Schweiz AG seeks a Director, Therapeutic Area Biomarker Lead in Neuroscience for a hybrid role in Basel. The position focuses on biomarker strategy, team leadership, and regulatory collaboration.

This role is dedicated to shaping and executing the biomarker strategy for a portfolio of neuroscience programs. The incumbent serves as the primary Biomarker Development representative on biomedical research and development project teams, with the overarching goal of advancing innovative therapies for patients.

Responsibilities

• Orchestrate biomarker and diagnostic activities for clinical projects by collaborating with research, development, precision medicine, and commercial teams.
• Anticipate potential project obstacles, devise solutions, and create contingency plans to ensure smooth progress.
• Provide supervision, training, and mentorship to Biomarker Experts while ensuring excellence in line functions.
• Deliver expert biomarker insights for key clinical and regulatory documents, including study protocols, reports, and applications.
• Own the biomarker sections of study protocols, reports, project summaries, and development plans to ensure regulatory compliance.
• Formulate and submit appropriate responses to inquiries from Health Authorities on a global scale.
• Lead or co-lead the Translational Data Science Committee (TDSC) and oversee analytical clusters.
• Manage biomarker analyses, integrating and interpreting data to report findings to project teams.
• Direct Biomarker sub-teams and coordinate effectively with relevant sub-team members.
• Maintain and deepen technical expertise in drug development while training other Biomarker Development associates.
• Publish findings as a primary contributor and review current literature to stay abreast of industry advancements.

Requirements

• PhD or PharmD degree with a robust background in biomarker development or related biological sciences.
• Eight to ten years of experience in drug development functions, such as biomarker or translational science.
• At least five years of experience within a relevant line function in industry, academia, or a regulatory agency.
• Comprehensive knowledge of disease biomarkers, pharmacology, and pharmacokinetic and pharmacodynamic evaluation.
• Strong grasp of regulatory requirements and experience supporting clinical and regulatory documentation.
• Proven track record of leading and influencing multidisciplinary global project teams, with strong negotiation skills.
• Demonstrated leadership capabilities, including coaching, mentoring, and people management.
• Fluent proficiency in English, both spoken and written.
• Excellent organizational and project management skills.

Nice to have

• Proficiency in additional languages is considered an advantage.

About the company

Novartis Pharma Schweiz AG is dedicated to shaping the future of medicine. The company strives to make a meaningful impact in neuroscience by helping to bring innovative therapies to patients.

• Focused on shaping the future of medicine.
• Committed to making a meaningful impact in neuroscience and helping bring innovative therapies to patients.