Clinical Development Lead

Roche • Tucson, AZ

1d

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. Roche Diagnostics provides integrated solutions for diagnostic testing in commercial and hospital labs, medical centers and laboratory networks. Our products and solutions support health care professionals in clinical decision making in a wide field of indications including, cardiovascular, infectious diseases, metabolism, and oncology. The Opportunity: This position is offered in the Clinical Evidence IVD team within the Clinical Development Chapter. As a Clinical Development Lead you will leverage your scientific and medical knowledge to support the design and development of Personalized Healthcare Solutions (PHCS) in the oncology/pathology customer area. Actively participate in cross functional teams supporting clinical study design and execution, including critical review of study results, protocol and report generation to support new product development. Conduct comprehensive literature reviews, cohesively collates relevant clinical and scientific information from different sources, and creates new scientific content in collaboration with Subject Matter Experts. Support with medical/scientific input and assists with the preparation of regulatory submissions as well as responses to reviewers from regulatory agencies, as applicable. Develop clinical, regulatory, and scientific expertise as it relates to In-Vitro Diagnostic (IVD) product development Assess clinical evidence and state of the art in medicine related to the IVD products to assess and demonstrate clinical benefit and safety. Work and align with Post-Market Surveillance & Vigilance (Global Regulatory & Quality) to support post-market obligations. Navigate complex situations with the support of experienced colleagues. Keeps 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. Who You Are:

Requirements

• You have a PhD in Life Science or related field with relevant expertise in the Healthcare Industry and/or academic institutions
• You have 2+ years academic, diagnostics or pharma industry experience,
• You have a basic understanding of clinical development including clinical study design and scientific writing experience
• You have a basic understanding of the healthcare industry
• You have good communication and presentation skills

Nice To Haves

• You have a PhD or PharmD
• You have experience with IVD or Medical Device related projects

Responsibilities

• Actively participate in cross functional teams supporting clinical study design and execution, including critical review of study results, protocol and report generation to support new product development.
• Conduct comprehensive literature reviews, cohesively collates relevant clinical and scientific information from different sources, and creates new scientific content in collaboration with Subject Matter Experts.
• Support with medical/scientific input and assists with the preparation of regulatory submissions as well as responses to reviewers from regulatory agencies, as applicable.
• Develop clinical, regulatory, and scientific expertise as it relates to In-Vitro Diagnostic (IVD) product development
• Assess clinical evidence and state of the art in medicine related to the IVD products to assess and demonstrate clinical benefit and safety.
• Work and align with Post-Market Surveillance & Vigilance (Global Regulatory & Quality) to support post-market obligations.
• Navigate complex situations with the support of experienced colleagues.
• Keeps 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree