Senior Manager Precision Medicine, Digital Health

The Senior Manager Precision Medicine and Digital Health will play a pivotal role in advancing the integration of cutting-edge technologies and personalized healthcare solutions within the organization. This individual will drive initiatives at the intersection of genomics, data science, and digital health, enabling innovative approaches to patient care and outcomes. They will collaborate with cross-functional teams to develop and execute strategies that align with the organization's mission and goals.

Responsibilities:

Develop and execute Precision Medicine and Digital Health (PM/DH) regulatory strategies for assigned assets across the therapeutic portfolio, ensuring alignment with global regulatory requirements, internal policies, and delivering optimal labeling based on available data.

• Develop and implement regional and global PM/DH regulatory strategies, ensuring timely delivery in collaboration with cross-functional teams.
• Lead regulatory interactions and processes, including communication with regulatory authorities and external partners.
• Ensure compliance with regulations throughout the product lifecycle.
• Advocate for innovative regulatory approaches to senior leadership and health authorities.
• Assess PM/DH components in potential in-licensing opportunities.
• Challenge and refine processes to improve performance.
• Set and achieve ambitious yet realistic team goals.
• Foster effective matrix collaboration and communication.
• Resolve conflicts and deliver creative, compliant solutions to regulatory challenges.
• Make sound decisions under uncertainty, balancing risks and benefits.

Requirements:

• BSc in a scientific field
• Minimum 7 years' of regulatory experience with in vitro diagnostics, companion diagnostics, and SaMD in a major market
• Experience with clinical trial and licensing requirements for PM/DH products

Preferred Qualifications:

• MS or PhD in related fields
• Proven leadership in global development, submissions, and regulatory approvals
• Strong communication, conflict resolution, and change management skills
• Ability to deliver impactful results and lead teams in complex regulatory environments