Global Clinical Program Lead
About The Position
The Global Clinical Program Lead ensures proactive alignment among Life Cycle Teams (LCTs), Project Teams, medical and clinical functions, evidence-generation teams, and execution strategies within CDMA. The role drives the planning, development, and delivery of evidence-generation programs, with accountability for program progress, budgets, timelines, strategic scenario assessments, and proactive risk management in partnership with cross-functional stakeholders, including LCT Project Leads, Regulatory Affairs, R&D, Pharma Partners, and other CDMA chapters. The role also drives development of Integrated Evidence Generation Plans for products in scope, working with internal and external stakeholders. It collaborates with Functional Partners and Sub-Chapter Leads to ensure appropriate resource allocation through timely communication of demands and skill-set requirements, aligned with the priorities of CDMA Networks and Project Teams.
Requirements
- Bachelor’s degree or advanced degree in Life Sciences, or relevant healthcare-industry expertise, a related field, or equivalent relevant experience.
- Experience in diabetes care is required.
- Generally 10 or more years of experience in diagnostics, medical device biotechnology, and/or pharmaceutical clinical trials, with responsibility for major aspects of strategic planning, design, organization, implementation, and delivery of clinical programs.
- Knowledge of and ability to apply and ensure adherence to ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, Bfarm, NMPA, and other relevant regulations.
- Excellent verbal and written communication skills in English.
- Ability and willingness to travel up to 25%; travel may vary by month and program.
- Ability to perform in a fast-paced, matrixed environment requiring flexible, adaptive, cross-team collaboration.
- Patient- and customer-centric mindset, with the ability to partner across diverse regions, cultures, and time zones.
Nice To Haves
- Background in multiple disease areas.
Responsibilities
- Ensure proactive alignment with LCTs and Project Teams, medical and clinical functions, evidence generation, and execution strategies within CDMA.
- Drive the planning, development, and delivery of evidence-generation programs.
- Maintain accountability for program progress, budgets, timelines, strategic scenario assessments, and proactive program risk management in partnership with cross-functional stakeholders.
- Drive development of Integrated Evidence Generation Plans for products in scope, partnering with internal and external stakeholders.
- Collaborate with Functional Partners and Sub-Chapter Leads to ensure adequate resource allocation by communicating demands and skill-set requirements in a timely manner and aligning with CDMA Network and Project Team priorities.
- Apply and ensure adherence to applicable regulations across programs, including ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, Bfarm, and NMPA requirements.
- Partner across diverse regions, cultures, and time zones, and work across Clinical Development and Medical Affairs communities to identify collaboration opportunities.
- Put patients’ and customers’ needs first and model Roche’s values and We@Roche Diagnostics culture, mindset, and behaviors.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- The position qualifies for the benefits detailed at the linked benefits page.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
