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

The Opportunity:

The key accountabilities for this position include:

• Ensure proactive alignment with LCT (Life Cycle Teams) / PT (Project Teams), medical/clinical, evidence generation and execution strategies within CDMA.

• Drive planning, development and delivery of evidence generation programs that meet US FDA and IVDR requirements, with full accountability for the program progress, budgets, timelines, strategic scenario assessments, proactive program risk management in partnership with cross-functional stakeholders including LCT Project Leads, Regulatory Affairs, R&D (Research & Development), Diagnostics Partners and other CDMA chapters. 

• Provide oversight of programs and respective studies to ensure compliance with US FDA regulations.

• Drive the development of the Integrated Evidence Generation Plan for products in scope and in partnership with internal and external stakeholders while applying applicable US FDA regulations for trial registrations within the US.

• In collaboration with the Functional Partner (FP) and Sub-Chapter Leads (SCL), ensure adequate allocation of resources by timely communication of demands and skill set requirements in alignment with priorities of the respective CDMA Networks and Project Teams.

• May be nominated as Functional Partner acting as the key strategic partner for LCTs (primary interface of CDMA and LCTs) with subject matter expertise, providing guidance for priority, budgets and capacity coordination within chapter and/or sub-chapter;  enabling the joint CDMA delivery on the LCT strategy and collaborating with CDMA Network, Indication Leads and CDMA Chapters to align strategic decisions at the CA LT (Customer Areas Leadership Teams) and SPC (Solution Portfolio Committee). 

• Accountable for the oversight of program-level budget of assigned programs.

Who You Are:
(Required)

• 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 Clinical Development and Medical Affairs 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.

• Leverage excellent verbal and written communication skills (English).

• Model Roche’s values of integrity, courage, and passion and operating principles (culture, mindset and behaviors) in everything you do.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of Indianapolis is $157,300 to $292,100.  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. Benefits

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