Clinical Development Lead, Oncology/Pathology

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The Position

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)

Who You Are

• 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

The primary location for this position is Tucson, Arizona, USA (preferred). We will consider US remote candidates.

Relocation benefits aren't offered for this position

The expected salary range for this position is based on the primary location Tucson, AZ is 120,500-223,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance.

This position also qualifies for the benefits detailed at the link provided below.

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.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.