Global Clinical Program Lead

2291 Roche Molecular Systems, Inc.; Pleasanton (CA); On-site; USD 147,000 - 272,000; Full time

Job summary

Roche in Pleasanton, CA is seeking an experienced leader to drive planning, development, and delivery of evidence generation programs across CDMA. You will manage budgets, timelines, and risks while partnering with Regulatory Affairs, R&D, and Pharma Partners to advance diagnostics and SaMD initiatives.

The role requires 10+ years in diagnostics/biotech/pharma clinical trials, a Life Sciences degree, and travel up to 25%.

Qualifications

• Drive patient and customer-centricity by always putting patients and the customers first.
• Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity.
• Work across Clinical Development and Medical Affairs 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 in everything you do.

Responsibilities

• Drive planning, development, and delivery of evidence generation programs with full accountability for program progress, budgets, timelines, strategic scenario assessments, and proactive program risk management in partnership with cross-functional stakeholders.
• 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 and Sub-Chapter Leads, through timely communication of demands and skill set requirements.
• Align with priorities of the respective CDMA Networks and Project Teams.

Education

Life Sciences degree

Job description

Company Culture

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 Opportunity

In this role 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.

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 in diabetes care is a must, 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. You are able and willing to travel up to 25% (can vary/month/program).

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.

Other Information

Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of Pleasanton, CA is $146,600 - 272,200 USD Annual. 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 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.