Senior Director, Clinical Trials & PMA Strategy

Shifamed; Los Gatos (CA); On-site; USD 200,000 - 230,000; Full time

Job summary

Supira Medical, a clinical-stage Shifamed portfolio company, seeks a Sr. Director, Clinical Affairs to own the IDE pivotal trial from site activation to database lock.

You will partner with R&D, Regulatory, Quality, and Marketing, managing CROs, sites, and KOLs to ensure on-time, within-budget execution and data integrity for PMA readiness. Ideal candidate has 15+ years in medical device clinical research, deep FDA/ISO knowledge, and leadership experience scaling a team; travel about 50% is

Qualifications

• 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 clinical trial for cardiovascular/structural heart devices, from site activation through submission.
• Knowledge of FDA regulations (21 CFR Parts 812, 50, 56, 820), GCP/ICH E6, and ISO 14155.

Responsibilities

• Own end-to-end execution of the IDE pivotal clinical trial, including site activation, enrollment, monitoring, data collection, and database lock.
• Finalize clinical protocol, study Charters, project plans, statistical analysis plan, and informed consent documents; lead amendments as needed.
• Oversee site management, CROs, core labs, DSMBs, and CECs; maintain relationships with investigators and trial staff.
• Engage with regulatory and quality processes to ensure FDA/ISO compliance and audit readiness.
• Travel approximately 50% to clinical sites and professional meetings; present to executive leadership and boards.

Skills

Clinical trial management

Budget management

Regulatory compliance

Vendor management

Cross-functional leadership

Education

Bachelor's degree in life sciences, nursing, or related field

Advanced degree (MS, PhD, RN, or equivalent)

Job description

Supira Medical, a clinical-stage Shifamed portfolio company, seeks a Sr. Director, Clinical Affairs to own the IDE pivotal trial from site activation to database lock.

You will partner with R&D, Regulatory, Quality, and Marketing, managing CROs, sites, and KOLs to ensure on-time, within-budget execution and data integrity for PMA readiness. Ideal candidate has 15+ years in medical device clinical research, deep FDA/ISO knowledge, and leadership experience scaling a team; travel about 50% is