Principal Upstream Clinical Program Manager

Principal Upstream Clinical Program Manager

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women's health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member's contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location: Remote position

Travel Expectation: Occasionally, based on business needs. For example, on-site meetings and work conferences.

Position Summary:

The Principal Upstream Clinical Program Manager will integrate with R&D during product development for new device indications and will partner with Regulatory, Marketing, and R&D to design pre-market feasibility and pivotal clinical studies to satisfy regulatory requirements and support marketing claims. This position will play a critical role in generating evidence for future applications of histotripsy, with a focus on neurology.

Key Responsibilities:

• 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

Qualifications and Skills:

The requirements listed below are representative of the knowledge, skill, and/or ability necessary for satisfactory performance. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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

HistoSonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.