Global Clinical Program Lead
About The Position
The Global Clinical Program Lead ensures proactive alignment across Life Cycle Teams and Project Teams, medical and clinical functions, evidence generation, and execution strategies within CDMA. The role has full accountability for planning, developing, and delivering evidence generation programs, including program progress, budgets, timelines, strategic scenario assessments, and proactive risk management in partnership with cross-functional stakeholders such as LCT Project Leads, Regulatory Affairs, R&D, Pharma Partners, and other CDMA chapters. The position drives development of Integrated Evidence Generation Plans for products in scope with internal and external stakeholders. It also ensures appropriate resource allocation by collaborating with Functional Partners and Sub-Chapter Leads, communicating resource demands and skill requirements in a timely manner and aligning them with CDMA Network and Project Team priorities. The role is based on the primary location of Pleasanton, California. Travel of up to 25% may be required, with the amount varying by month and program. Relocation benefits are not available.
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 devices, 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 applicable ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, Bfarm, and NMPA regulations across programs.
- Willingness and ability to travel up to 25%; travel may vary by month and program.
- Excellent verbal and written communication skills in English.
- Flexibility and adaptability to work in a fast-paced, matrixed environment requiring fluid cross-team collaboration.
- Ability to partner across diverse regions, cultures, and time zones.
Nice To Haves
- Background in multiple disease areas.
Responsibilities
- Ensure proactive alignment with Life Cycle Teams and Project Teams, medical and clinical functions, evidence generation, and execution strategies within CDMA.
- Plan, develop, and deliver evidence generation programs, with accountability for program progress, budgets, timelines, strategic scenario assessments, and proactive risk management.
- Partner with cross-functional stakeholders, including LCT Project Leads, Regulatory Affairs, R&D, Pharma Partners, and other CDMA chapters.
- Drive development of Integrated Evidence Generation Plans for products in scope in partnership with internal and external stakeholders.
- Collaborate with Functional Partners and Sub-Chapter Leads to ensure adequate resource allocation.
- Communicate resource demands and skill-set requirements in a timely manner, aligned with the priorities of CDMA Networks and Project Teams.
- Work across Clinical Development and Medical Affairs communities to identify mutual value and opportunities for collaboration.
- Promote patient- and customer-centricity and contribute to an inclusive environment across diverse regions, cultures, and time zones.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- The position qualifies for company benefits detailed through the benefits link.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
