Director, Clinical Affairs

Title: Director, Clinical Affairs

Company: Medical Device Company

Location: Remote

We are working with a privately held, innovation-driven medical technology organization focused on developing transformative therapies that address unmet clinical needs. Backed by a proven track record of successful ventures and led by experienced entrepreneurs, the team is passionate about advancing healthcare through novel solutions and collaborative execution. The company culture values agility, integrity, and scientific excellence, with a strong commitment to improving patient outcomes through meaningful innovation.

Position Summary

The Director of Clinical Affairs is a strategic and hands-on leader responsible for driving clinical programs from early feasibility through pivotal trials to regulatory approval and market launch. This role combines deep scientific expertise, operational excellence, and cross-functional leadership to ensure clinical trials are executed efficiently, compliantly, and with high-quality outcomes.

Key Responsibilities

• Lead clinical strategy, trial design, and execution across all phases of development, ensuring alignment with corporate goals and regulatory requirements.
• Oversee selection, negotiation, and management of Contract Research Organizations (CROs) and other clinical vendors.
• Design, plan, and manage clinical trials including protocol development, site recruitment, compliance approvals, budget and contract negotiation, study initiation, monitoring, data analysis, and reporting.
• Ensure adherence to GCP, ICH, ISO 14155, and applicable FDA regulations (21 CFR Parts 50, 54, 56, 812, 814).
• Develop and review clinical documentation including protocols, case report forms, monitoring plans, study reports, and regulatory submissions.
• Serve as subject matter expert on cross-functional project teams, interfacing with IRBs, CECs, DSMBs, and Key Opinion Leaders (KOLs).
• Contribute to publication strategy, including abstract and manuscript development, and support scientific and clinical advisory board meetings.
• Provide clinical input into risk management plans, design reviews, Instructions for Use (IFUs), and product labeling.
• Represent the company at external meetings, scientific congresses, and investigator interactions.

Qualifications

Education:

• Bachelor's degree in life sciences, bioengineering, biomedical engineering, mechanical/electrical engineering, or related field; advanced degree preferred.

Experience:

• Minimum of 10 years of experience in clinical trial management, preferably in medical devices.
• At least 3 years in a leadership role managing clinical affairs teams and external partners.
• Proven ability to lead and manage clinical trials from feasibility to pivotal stages, both in the U.S. and internationally.
• Strong understanding of clinical data management, safety reporting, and statistical analysis plans.

Skills:

• Exceptional organizational and stakeholder management skills.
• Effective negotiator with experience in clinical contracts and vendor management.
• Experience with cardiovascular devices or structural heart therapies is highly preferred.
• Excellent communication skills, both written and verbal, with the ability to present complex data clearly.
• Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
• Prior experience as a Clinical Research Associate (CRA) is a plus.