Principal Upstream Clinical Program Manager

🕒 May 6

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $170k - $190k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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HistoSonics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2009

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

HistoSonics, Inc. is a pioneering medical technology company that has developed a non-invasive sonic beam therapy platform using a treatment called histotripsy. This innovative approach harnesses focused ultrasound to mechanically destroy targeted liver tumors at a sub-cellular level. HistoSonics is dedicated to advancing the science of histotripsy, aiming to provide transformative benefits for patients and physicians worldwide, particularly through its ongoing clinical trials and educational programs.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• health, dental, and vision insurance • life insurance • short-term and long-term disability insurance • 401(k) • paid time off