Principal Upstream Clinical Program Manager

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Provides strategic direction for upstream clinical initiatives, collaborating with key stakeholders to design clinical studies that align with essential business objectives which may encompass the following:

• Gather clinical safety and performance data to fulfill regulatory requirements in significant regions.

• Accumulate clinical data to satisfy post-market obligations (e.g., CPT code submissions, marketing claims, etc.).

• Facilitates cross-functional alignment on CRF and data strategy, ensuring the collection of high-quality, decision-grade data that meets regulatory, scientific, and business demands.

• Collaborates with R&D, Professional Education, and Medical Affairs to assist in procedure development for new indications.

• Aids in the planning and coordination of clinical advisory boards to steer research activities as necessary.

• Supports the Regulatory Affairs and Quality Assurance teams in preparing for reporting and submissions.

• May assist in both internal and external audits.

• Cultivates and maintains robust relationships with physician collaborators.

⛳️ Requirements

• Bachelor’s degree is required, preferably in science, medicine, or a related field; an advanced degree is highly preferred.

• A minimum of 8-10 years of progressive experience in medical device clinical studies, with at least 3 years in neurology strongly preferred.

• Familiarity with, and experience in, the FDA and EU regulatory environments, with a preference for experience supporting global clinical strategies.

• Exceptional written and verbal communication skills.

• Strong analytical, critical thinking, and problem-solving abilities with the capacity to interpret and analyze data.

• Proven collaboration and leadership skills.

• Capable of engaging in high-level technological and clinical discussions.

• Ability to articulate complex technology in clear, understandable terms.

• Proven track record of developing and fostering relationships both internally and externally.

• Demonstrated ability to effectively prioritize multiple tasks and meet deadlines, along with excellent follow-through skills.

• A strong history of translating strategic plans into prioritized product, development, and/or operational objectives.

• Demonstrated capability to manage shifting priorities in a fast-paced environment while ensuring communication with the team and manager.

• Proficient in Microsoft Office, including Word and PowerPoint.

🏝️ Benefits

• Health, dental, and vision insurance.

• Life insurance.

• Short-term and long-term disability insurance.

• 401(k).

• Paid time off.