Provides strategic leadership for upstream clinical programs, partnering with key stakeholders to design clinical studies that meet key business objectives which may include the following:
Collect clinical safety and performance data to meet regulatory requirements in key regions
Collect clinical data to meet post-market requirements (e.g., CPT code applications, marketing claims, etc.)
Drives cross‑functional alignment on CRF and data strategy, ensuring collection of high‑quality, decision‑grade data that meets regulatory, scientific, and business needs.
Partners with R&D, Professional Education and Medical Affairs to aid in procedure development for new indications.
Supports the planning and coordination of clinical advisory boards to guide research activities as needed
Assists the Regulatory Affairs and Quality Assurance teams in preparation for reporting and submissions
May assist in internal and external audits
Develops and maintains strong relationship with physician collaborators

Bachelor’s degree required. Science, medicine or similar discipline; advanced degree strongly preferred.
Minimum of 8-10 years of progressive medical device clinical study experience, a minimum of 3 years in neurology strongly preferred
Knowledge of, and experience with, the FDA and the EU regulatory environments, with experience supporting global clinical strategies preferred
Excellent written and verbal communication skills
Strong analytical, critical thinking, and problem-solving skills with the ability to interpret and analyze data
Demonstrated collaboration and leadership abilities
Ability to participate in high-level technological and clinical discussions
Ability to discuss complex technology in clear, discernible terms
Demonstrated ability to develop and maintain relationships, internally and externally.
Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills.
Demonstrated record of converting strategic plans to prioritized product, development, and/or operational objectives
Demonstrated ability to handle shifting priorities in a fast-paced environment while maintaining communication with team and manager
Proficient in Microsoft Office, Word, and Power Point

Principal Upstream Clinical Program Manager

Key skills