Senior Director, Clinical Regulatory Affairs

At Novocure, every role contributes to extending the lives of people living with cancer. As our new Senior Director, Clinical Regulatory Affairs , you’ll play a key part in this mission. This is a highly visible global leadership role at the intersection of clinical development, oncology science, regulatory strategy, and commercialization readiness. This position is designed for a strategic leader who can shape how innovative Class IIb/III medical technologies are positioned within evolving oncology treatment paradigms and alongside emerging therapeutic regimens. Reporting to the Vice President, Global Regulatory Affairs, you will serve as a key scientific and regulatory thought partner across Clinical Affairs, Medical Affairs, Marketing, Legal, R&D, and executive leadership. You will help define evidence generation strategies, guide global health authority engagement, and influence the regulatory pathways that support product approvals, label expansion opportunities, and long-term global market adoption. This role will play a critical part in advancing Novocure’s transformative oncology therapies and shaping the future of cancer treatment. WHAT YOU’LL DO In this role, you will lead the development and execution of global clinical-regulatory strategies for Novocure’s Class IIb/III medical device portfolio, supporting programs from early clinical development through commercialization and lifecycle expansion. Develop and lead global clinical regulatory strategies for innovative Class IIb/III medical devices across the full product lifecycle, from early clinical development through commercialization and lifecycle expansion. Shape regulatory approaches that support clinical evidence generation, product positioning, and future label expansion opportunities within evolving oncology standards of care. Partner closely with Clinical Affairs, Medical Affairs, R&D, Marketing, Legal, Quality, and Regulatory Operations to align regulatory strategy with clinical and business objectives. Provide strategic regulatory guidance for clinical study design, protocol development, investigator brochures, informed consent documentation, and overall study execution. Lead and support interactions with global health authorities, including FDA, EMA and Notified Bodies, serving as the primary regulatory contact for clinical and strategic matters. Prepare and lead teams through critical regulatory engagements including pre-submission meetings, advisory panels, inspections, and regulatory negotiations. Author, review, and oversee high-quality regulatory documentation including IDEs, PMAs, EU clinical trial applications and related clinical regulatory submissions. Interpret and apply complex global regulatory requirements to support development programs involving novel technologies and breakthrough device opportunities. Support global product launch readiness, labeling strategy, and promotional review activities in alignment with evolving regulatory expectations. Contribute to internal governance discussions, risk assessments, and strategic go/no‑go decisions related to clinical development programs. Lead, mentor, and develop a high‑performing regulatory team while fostering strong cross‑functional collaboration and scientific credibility across the organization. ABOUT YOU Master’s degree in life sciences, biomedical engineering, or a related field required; advanced degree preferred. Minimum of 10–12 years of regulatory affairs experience across biotechnology, pharmaceutical, and medical device environments, including significant experience with Class III medical devices and at least 5 years in a leadership role. Deep expertise with IDEs, PMAs, CE Mark submissions, and global clinical regulatory strategy for high‑risk medical devices. Proven experience engaging directly with FDA and other global regulatory authorities on complex clinical and regulatory matters. Strong understanding of clinical study design, statistical principles, and regulatory requirements supporting innovative oncology and high‑risk medical device programs. Demonstrated ability to develop regulatory strategies that balance scientific, clinical, regulatory, and business objectives. Strong leadership presence with exceptional communication and cross‑functional influencing skills. These additional qualifications are preferred: Experience supporting oncology‑focused products or therapies within pharmaceutical, biotechnology, medical device, or combination product environments. Deep understanding of global regulatory environments, including FDA, EU MDR, and Asian markets. Familiarity with software as a medical device (SaMD) and/or combination product environments. Experience supporting product launch preparation, commercialization activities, advertising, promotion, and labeling strategies. Familiarity with digital and social media regulatory review. Experience operating within highly matrixed, global organizations where regulatory strategy, clinical evidence generation, and commercialization readiness are closely connected. NOVOFLEX We offer a flexible, trust‑based hybrid working model for most of our office‑based roles. Employees are asked to be in Baar, Zug office an average of three days per week, with the flexibility to choose which days’ work best for them. We understand that life is not always predictable, so if you need to adjust your schedule, such as leaving early or starting late occasionally, we trust you to balance your time in a way that works for both you and Novocure. #J-18808-Ljbffr