Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com.
Description:
The Senior Director, Clinical Affairs is a hands-on leadership role responsible for driving the execution and overall success of Supira Medical's IDE pivotal clinical trial. This individual will own the operational, strategic, and cross-functional execution of the trial - from site activation through database lock - and will serve as the primary internal owner ensuring the study is executed on time, within budget, in full compliance with FDA and ISO 14155 requirements, and with the data integrity needed to support a successful PMA submission. This role partners closely with the R&D, Quality, Regulatory Affairs, and Marketing, and manages relationships with CROs, clinical sites, and key opinion leaders (KOLs).
Responsibilities, Skills & Hands-On Experience:
- Clinical Trial Execution: Own end-to-end execution of the company's IDE pivotal clinical trial, including site activation, enrollment, monitoring, data collection, and database lock, ensuring the study stays on timeline and within budget. Develop and propose strategies to address study issues.
- Protocol, Study Design, & Trial Documentation: Partner cross-functionally to finalize/amend the clinical protocol, study Charters, project plans, statistical analysis plan, and informed consent documents; lead content and completion of amendments to study documents, as needed.
- Site Management: Work closely with the Lead CRA and Site Manager to oversee site selection, contracting, and activation; build and maintain strong relationships with principal investigators, coordinators, and clinical staff at trial sites.
- CRO & Vendor Oversight: Select, onboard, and manage CROs and other clinical vendors (core labs, DSMB, CEC, EDC providers); hold Supira study team accountable to keep vendors on-target and accountable to scope, quality, and timeline. Identify gaps and source new vendors, contractors, or CROs to strategically fill gaps.
- KOL Engagement: Cultivate and maintain relationships with KOLs, national PIs, and the trial steering committee; represent Clinical Affairs at investigator meetings and medical/scientific conferences.
- Regulatory & Quality Compliance: Ensure the trial is conducted in accordance with ISO 14155 and FDA 21 CFR Parts 812/50/56; oversee monitoring plans, audit readiness, and CAPA resolution.
- Timeline Management: Own the clinical trial timeline; provide regular status updates, risk assessments, and mitigation plans to executive leadership and the Board.
- Data Integrity & Oversight: Oversee data management and monitoring plans in partnership with Biostatistics and Data Management to ensure data integrity and audit-readiness; support DSMB and CEC operations.
- Regulatory Submission Support: Provide clinical input and data support for IDE supplements, PMA modules, and interactions with FDA; support preparation for Pre-Submission and Panel meetings as needed.
- Cross-Functional Leadership: Ability to work across functions and within an executive team to drive change in a positive, collaborative and transparent way. Collaborate cross-functionally with R&D, Regulatory, Quality, and Marketing to align clinical strategy with product development and commercialization goals.
- Team Building: Build, mentor, and motivate a growing Clinical Affairs team, including clinical research associates/managers, field clinical specialists, and contractors, as the trial scales.
Education & Work Experience:
- Bachelor's degree in life sciences, nursing, or related field required; advanced degree (MS, PhD, RN, or equivalent) a plus.
- 15+ years of progressive clinical research/clinical affairs experience in the medical device industry, including at least 10 years in a leadership role.
- Direct experience managing an IDE pivotal (or comparable premarket) clinical trial for a cardiovascular, structural heart, or other Class III cardiac device, from site activation through submission.
- Deep working knowledge of FDA regulations (21 CFR Parts 812, 50, 56, 820), GCP/ICH E6, and ISO 14155.
- Demonstrated experience managing CROs, core labs, DSMBs, and CECs, and working directly with FDA on IDE-related submissions.
- Proven ability to manage complex budgets, timelines, and cross-functional stakeholders in a fast-paced, resource-constrained startup environment.
- Excellent written and verbal communication skills, with experience presenting to executive leadership, Boards, and external investigators.
- Willingness and ability to travel approximately 50% to clinical sites and professional meetings.
- Prior experience with a cardiovascular device supporting patients with heart failure, cardiogenic shock, or high-risk PCI (e.g., mechanical circulatory support, transcatheter valve, or structural heart devices), preferred.
- Experience at an early-stage or venture-backed medical device company, including scaling a clinical affairs function from a small team, preferred.
- Direct experience preparing for and participating in FDA Pre-Submission meetings, Panel meetings, or PMA reviews, preferred.
- RAC, CCRA, ACRP, or SoCRA certification, preferred.
Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $200,000 to $230,000 + equity + benefits.
