Clinical Operations Lead

Roche • Pleasanton, CA

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 As the Clinical Operations Lead, you will be a strategic and planning expert in Clinical Operations Program Leadership, partnering with key stakeholders and CDMA (Clinical Development & Medical Affairs) functions to deliver diagnostic solutions through successful designing, planning, and coordination of high-quality and efficient evidence generation activities for registrational and non-registrational purposes. The Opportunity You will ensure proactive alignment with LCT (Life Cycle Teams) / PT (Project Teams), medical/clinical, evidence generation, and execution strategies within CDMA. You will drive planning, development, and delivery of evidence generation programs with full accountability for the program progress, budgets, timelines, strategic scenario assessments, and proactive program risk management in partnership with cross-functional stakeholders, including LCT Project Leads, Regulatory Affairs, R&D (Research & Development), Pharma Partners, and other CDMA chapters. Drive the development of the Integrated Evidence Generation Plan for the products in scope in partnership with internal and external stakeholders. Ensure adequate allocation of resources by collaborating with the Functional Partner (FP) and Sub-Chapter Leads (SCL), through timely communication of demands and skill set requirements in alignment with priorities of the respective CDMA Networks and Project Teams. You will act as the Functional Partner if nominated, serving 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 the chapter and/or sub-chapter, and enabling the joint CDMA delivery on the LCT strategy while collaborating with CDMA Network, Indication Leads, and CDMA Chapters. Who You Are You have a Bachelor’s degree or an advanced degree in Life Sciences and/or relevant expertise in the healthcare industry, a related field, or equivalent relevant experience. Experience or background in multiple disease areas is a plus. Generally 10+ years of experience in diagnostics, medical device biotechnology and/or pharmaceutical clinical trials with responsibilities for managing all major aspects of strategic planning, design, organization, implementation, and delivery of clinical programs. Understands, applies good knowledge of, and ensures adherence to ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, Bfarm, NMPA regulations, etc across the respective programs to ensure objectives are met in support of CDMA and/or Diagnostics goals. Knowledge, Skills and Abilities 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 We@Roche Diagnostics (culture, mindset and behaviors) in everything you do.

Requirements

• Bachelor’s degree or an advanced degree in Life Sciences and/or relevant expertise in the healthcare industry, a related field, or equivalent relevant experience.
• Generally 10+ years of experience in diagnostics, medical device biotechnology and/or pharmaceutical clinical trials with responsibilities for managing all major aspects of strategic planning, design, organization, implementation, and delivery of clinical programs.
• Understands, applies good knowledge of, and ensures adherence to ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, Bfarm, NMPA regulations, etc across the respective programs to ensure objectives are met in support of CDMA and/or Diagnostics goals.
• 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 We@Roche Diagnostics (culture, mindset and behaviors) in everything you do.

Nice To Haves

• Experience or background in multiple disease areas is a plus.

Responsibilities

• 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 with full accountability for the program progress, budgets, timelines, strategic scenario assessments, and proactive program risk management in partnership with cross-functional stakeholders, including LCT Project Leads, Regulatory Affairs, R&D (Research & Development), Pharma Partners, and other CDMA chapters.
• Drive the development of the Integrated Evidence Generation Plan for the products in scope in partnership with internal and external stakeholders.
• Ensure adequate allocation of resources by collaborating with the Functional Partner (FP) and Sub-Chapter Leads (SCL), through timely communication of demands and skill set requirements in alignment with priorities of the respective CDMA Networks and Project Teams.
• Act as the Functional Partner if nominated, serving 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 the chapter and/or sub-chapter, and enabling the joint CDMA delivery on the LCT strategy while collaborating with CDMA Network, Indication Leads, and CDMA Chapters.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level