Global Development Leader - Multiple Sclerosis

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionRoche’s Product Development (PD) organization is dedicated to delivering outstanding therapies to patients who need them. We conduct global clinical trials, analyze results, monitor safety, and work with regulatory authorities to provide truly differentiated medicines to patients. The Global Development Leader (GDL) plays an important role to achieve PD’s vision.The GDL leads the cross-functional global development team (GDT) to deliver the molecule with maximum impact for patients. The responsibilities of the GDL include developing development strategies and ensuring effective and efficient execution for the assigned molecule(s) and indication(s). The GDL is a core member of the Asset Team and represents the Asset Team on its clinical development strategy and execution plans to internal stakeholders as well as health authorities, payors, patient associations and other key external stakeholders.Roche is seeking a Global Development Leader with relevant drug development expertise for a Multiple Sclerosis (MS) drug development program. This position reports to PD Global Head for MS and Neuroimmunology.The OpportunityAs a Global Development Leader, you are responsible for leading and overseeing the strategic, scientific, executional and registrational aspects of assigned development programs. You demonstrate strategic perspective by leading the team on designing asset strategy and target product profile aligned with business goals, competitive intelligence, and long-term objectives, while staying abreast of internal and external trends and market dynamics.You demonstrate late stage clinical development expertise, including in the transition from early to late stages of development and leverage subject matter experts in the team and beyond for the molecule, science, clinical, disease area, and regulatory environment, partnering with internal and external drug development experts.You align team efforts with strategic direction, developing a ‘North Star’ vision, purpose, and strategy for the GDT in alignment with the Lifecycle team, and creating alignment with broader internal strategies.You have proven financial acumen, with the ability to interpret and leverage financial data to inform decision-making, budget management, and resource allocation, ensuring alignment with strategic goals and business performance. You contribute to business forecasting as an equal partner in the Asset Team, leveraging insights from PD for optimal product valuation and anticipating future developments to capture opportunities.Key contributor to the end to end asset strategy, bringing in late stage contributions and requirements into the early Asset Strategy, ensuring a robust end-to-end Asset Strategy. As the PD representative at the lifecycle team, contribute, drive and design the molecule Asset Strategy (incorporating Life Cycle plan, CDP, IDCP, ISP, IEP, Access etc. components), in alignment with the disease area strategy, if any.Who you areMD, MD/PhD, or PhD and disease area expertise in multiple sclerosis is preferred. 10 or more years pharma/biotech industry experience with at least 5 years in early/late stage development focusing on clinical trial design/execution.Extensive pharma/biotech industry experience with a proven record of leading strategic level teams and demonstrated experience in drug development.Proven track record in managing scientific and clinical teams in a matrixed organization.In-depth knowledge of Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, FDA, EMEA and other relevant guidelines and regulations. Experience submitting INDs/NDAs/BLAs to regulatory authorities. Extensive experience in leading interactions and meetings with regulatory authorities.Strong understanding of principles of data analysis, interpretation and clinical relevance. Strategic thinking and sound judgment, with the ability to make informed decisions by synthesizing detailed information, assessing risks, and balancing priorities effectively. Ability to critically evaluate scientific data with a working knowledge of the Product Development long-range plan and experience with cross-functional departments.Outstanding influencing and negotiation skills with an enterprise mindset and demonstrated effectiveness at conflict resolution. Proven ability to effectively work in a global, cross-functional matrix organization.Ability to train, mentor and coach team members and others.If you are an expert in Multiple Sclerosis, Neuroimmunology, and/or Neurology with outstanding leadership skills and are passionate about bringing transformational medicines to patients, we would love to hear from you.Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche’s largest sites.Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.Roche is an Equal Opportunity Employer. #J-18808-Ljbffr