- 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, 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.
- You will drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first.
- Partnering across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity.
- Demonstrating flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial.
- You will model Roche's values of integrity, courage, and passion and operating principles (culture, mindset and behaviors) in everything you do.
- This is a remote position.
- Travel Requirement: Approximately 20% of time travel domestic and/or international.
- You have an advanced degree in Life Science and/or relevant expertise in the Diagnostics and/or Pharma Industry or a related field
- You hold 10+ years of experience in diagnostics, biotechnology and/or pharmaceutical clinical trials with responsibilities for managing all major aspects of strategic planning, design, organization, implementation, and delivery of clinical programs
- You have a demonstrated track record of leading complex study programs in a global setting and across multiple disease areas in a Diagnostics, Pharma or CRO setting
- You will exhibit a broad knowledge in applicable standards and regulations (ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, NMPA regulations, etc.) and understanding of the healthcare industry
- You will display an understanding of Diagnostics Development Process (DCC) as well as associated processes (e.g. pre-DCC, post-launch) is essential for this role
- Profound project management experience and cross-functional leadership skills that serve, inspire and motivate others within the organization
- Proficiency and experience with planning and tracking tools (e.g. CTMS, eTMF)
- Knowledge of the typical experiments to characterize the performance of an IVD or Medical Device as well as practical experience in international study management, study protocol design, report writing and statistics
- Experience or background in PHCS / cDx and/or Oncology
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Clinical Program Lead - Indianapolis, United States - Hoffmann-La Roche Ltd
Description
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. 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.
As Site Management, we are the interface between Roche Diagnostics Study Teams and the external clinical study sites/Roche Customers performing the studies.
Through a collaborative and strong study site relationship, we ensure study/site compliance with applicable regulations and guidelines; affirming the integrity of the generated data and preserving the safety of patients.
It is with this expertise and mindset that Site Management facilitates successful clinical trials, which are essential to bringing Roche products to market.
The OpportunityAs a Clinical Program Leader, you will be a member of the Clinical Operations Program Leadership Chapter.
The strategic and planning experts in Clinical Operations Program Leadership collaborate within and beyond CDMA to deliver diagnostic solutions through the successful designing, planning and coordination of evidence generation activities for registrational and non-registrational study programs.
The Clinical Program Lead provides strategic guidance, drives strategic alignment and coordinates effective delivery of study programs in partnership with cross-functional stakeholders including LCT (Life Cycle Teams), Project Leads, Regulatory Affairs, R&D (Research and Development) and other Clinical Development & Medical Affairs (CDMA) chapters.
In addition, the Clinical Program Lead maintains the oversight on study program level in his / her area of responsibility with respect to quality, timelines and budget and is involved in risk identification and development of risk mitigation strategies.
ResponsibilitiesThe expected salary range for this position based on the primary location of Tucson is $128,200 - $238,000. 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
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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.
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