Clinical Development Lead (Neuroscience) at Roche

Burgess Hill, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

23 Aug, 26

Salary

0.0

Posted On

25 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Development Strategy, Neuroscience, Regulatory Filings, Stakeholder Management, KOL Relationship Building, Clinical Study Design, ICH-GCP, FDA Regulations, NMPA Regulations, IVDR, MDR, Medical Writing, Cross-functional Leadership, Mentoring, Intellectual Property Strategy, Clinical Utility Definition

Industry

Biotechnology Research

Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally. We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster. Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life. The Opportunity Are you ready to shape the future of healthcare by leading the clinical development strategy for next-generation diagnostic solutions? As a Clinical Development Lead, Neuroscience within our Clinical and Medical Affairs organisation in Diagnostics, you will play a pivotal role in planning and implementing clinical development activities that bring medically-differentiated solutions to patients globally. In this role, you will act as a senior strategic voice and trusted advisor, fostering an environment where science and collaboration thrive. Key Responsibilities: Drive Clinical Strategy: Lead the clinical development strategy for clinical diagnostic studies and complex programs, in the Neuroscience area, defining clinical utility, intended use, and claim extensions across our portfolio. Lead Health Authority Interactions: Work closely with Global Regulatory Affairs in the completion and submission of global regulatory filings, authoring critical sections of meeting packages and reviewing clinical documents for international regulatory submissions. Forge Stakeholder Partnerships: Act as the clinical lead in external interactions with health authorities, build strategic relationships with international Key Opinion Leaders (KOLs), and drive development partnerships across industry and academia. Foster Communication Excellence: Oversee the implementation of communication strategies for clinical studies, representing the organisation at major medical congresses, advisory boards, and in key publications. Champion Innovation & Excellence: Act as a key driver for competitive differentiation, innovation, and early pipeline activities while developing intellectual property strategies and optimising clinical processes. Coach and Mentor: Act as a dedicated coach for team members, nurturing confidence and helping colleagues develop their skills and expertise. Who You Are You are an analytical, strategic thinker who thrives in a fast-paced, matrixed environment. You are passionate about customer and patient-centricity, and you excel at integrating multiple cross-functional perspectives into a unified clinical strategy. Education: Medical degree (MD) or an advanced degree (PhD) in Neuroscience or related fields. Experience: Established experience within academia, diagnostics, or the pharmaceutical industry, preferably in the neuroscience area Clinical Development expertise: Demonstrated experience of designing and leading large, complex clinical development programs across all stages of the product development and guiding cross-functional, matrixed teams Regulatory Knowledge: Deep understanding of applicable global standards and regulations, such as ICH-GCP, FDA, and NMPA, experience with IVDD/IVDR and MDR preferred Inclusion & Collaboration: Ability to partner effectively across diverse regions, cultures, and time zones to foster an environment of belonging and collaboration. Travel: Willingness to travel up to 25% depending on project phases. Our combined strength in pharmaceuticals and diagnostics offers you a unique opportunity to create innovative solutions that transform patient care. At Roche, we aim high to deliver life-changing healthcare solutions. If you’re ready to make a meaningful impact on patients and healthcare systems worldwide, this is the place for you. Apply today! Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Burgess Hill. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

Lead the clinical development strategy for neuroscience diagnostic solutions, defining clinical utility and intended use. Manage global regulatory submissions and foster strategic partnerships with health authorities and Key Opinion Leaders.