Clinical Development Lead, Oncology/Pathology

Roche

4d•Remote

About The Position

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 A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The Clinical Development Lead, Oncology/Pathology is responsible for planning and implementation of Clinical Development activities for novel medical value diagnostic solutions in the areas of oncology and tissue-based pathology at Roche Diagnostic Solutions (RDS), with a primary focus on Companion diagnostic/Personalized Healthcare solutions. The Opportunity: Designs scientifically sound clinical studies and study programs in cross-functional teams Makes substantial contributions to the Clinical Development strategy for the relevant therapeutic/disease area(s) Leads clinical study design and execution, including critical review of study results, protocol and report generation to support new product development Works with colleagues from Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, Business, and other functions to ensure appropriate implementation of clinical development strategies Leads medical/scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies May participate in external interactions with health authorities (HAs) Maintains clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation Builds and maintains close relationships with external thought leaders, supports preparation of advisory boards within the assigned indication area Builds and maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring operational excellence Drives competitive differentiation, innovation and early pipeline activities and develops intellectual property strategy Develops and manages external development partnerships (industry and academia) Leads comprehensive literature reviews, supervises collation of relevant clinical and scientific information from different sources, and creates new scientific content (without guidance/direction) Solves or leads others to solve complex outcomes; uses sophisticated analytical thought to exercise judgment and identify innovative solutions Acts as a coach for colleagues with less experience and helps them develop skills/expertise Permanently optimizes processes to increase quality and efficiency standards Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity Working across Medical Affairs and Clinical Operations communities to identify mutual value and opportunities for collaboration Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial Model Roche’s values of integrity, courage, and passion (culture, mindset and behaviors)

Requirements

You have a medical degree or advanced degree (PhD, PharmD or equivalent) in Life Sciences, Oncology, Immunology, Molecular Biology and or Anatomic Pathology
You have 7+ years academic, diagnostics or pharma industry experience,
You have familiarity with global regulatory bodies (FDA, EMA, PMDA)
You have good knowledge in applicable standards and regulations (ICH-GCP, IVDD/IVDR, MDR, FDA, NMPA regulations etc.) and understanding of the healthcare industry or equivalent academic experience
You have in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial, etc. and can proactively integrate multiple perspectives into the clinical development process and strategy for best end-results
You have the ability to work with pharmaceutical partners to align the development of a diagnostic test with the development of a specific cancer drug
You have the ability to travel required up to 10% (can vary per project phase and position)
You have the ability to work independently

Responsibilities

Designs scientifically sound clinical studies and study programs in cross-functional teams
Makes substantial contributions to the Clinical Development strategy for the relevant therapeutic/disease area(s)
Leads clinical study design and execution, including critical review of study results, protocol and report generation to support new product development
Works with colleagues from Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, Business, and other functions to ensure appropriate implementation of clinical development strategies
Leads medical/scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies
May participate in external interactions with health authorities (HAs)
Maintains clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation
Builds and maintains close relationships with external thought leaders, supports preparation of advisory boards within the assigned indication area
Builds and maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring operational excellence
Drives competitive differentiation, innovation and early pipeline activities and develops intellectual property strategy
Develops and manages external development partnerships (industry and academia)
Leads comprehensive literature reviews, supervises collation of relevant clinical and scientific information from different sources, and creates new scientific content (without guidance/direction)
Solves or leads others to solve complex outcomes; uses sophisticated analytical thought to exercise judgment and identify innovative solutions
Acts as a coach for colleagues with less experience and helps them develop skills/expertise
Permanently optimizes processes to increase quality and efficiency standards
Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first
Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity
Working across Medical Affairs and Clinical Operations communities to identify mutual value and opportunities for collaboration
Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial
Model Roche’s values of integrity, courage, and passion (culture, mindset and behaviors)