Browse New and Exciting Opportunities
So sorry, this position is no longer available.
Please go ahead and submit your application. We may have other positions that would be the perfect fit for you.
Alternatively, you may want to apply to one of the following related jobs:
The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
true
Director of Clinical Research
Remote, NJ US
Posted: 02/02/2026
2026-02-02
2026-03-13
Employment Type:
Contract
Job Category: Operations and Development
Job Number: 4861
Job Description
The Director of Clinical Research serves as the strategic and operational leader for all clinical research activities within the organization. This executive role drives the design, execution, and dissemination of both academic and industry-sponsored clinical trials aimed at advancing reconstructive and regenerative surgery outcomes. The Director ensures that all research initiatives meet the highest standards of scientific rigor, patient safety, regulatory compliance, and operational excellence.
As a senior member of the leadership team, the Director will shape the organization’s research portfolio, foster partnerships with industry sponsors and academic institutions, and oversee the development of a robust Quality Management System (QMS) to ensure audit readiness and sustainable research growth across the consortium.
Key Responsibilities:Regulatory and Compliance Management
Ensure full compliance with FDA, IRB, and ICH-GCP standards for all sponsored and investigator-initiated studies.
Oversee preparation and submission of regulatory documents including protocols, informed consent forms, safety reports, and clinical study reports.
Maintain audit readiness and drive continuous improvement across research operations.
Stakeholder and Partnership Development
Serve as the primary liaison between the company and industry sponsors, academic collaborators, CROs, and regulatory agencies.
Strengthen strategic partnerships to expand company’s clinical research capabilities and funding base.
Support publication strategy and presentation of study outcomes at key academic and industry forums.
Leadership & Governance
Establish and manage a centralized research infrastructure across company sites, promoting consistency and operational efficiency.
Implement and maintain Standard Operating Procedures (SOPs) and Quality Management Systems (QMS) aligned with global best practices.
Lead and mentor cross-functional research teams encompassing clinical operations, biostatistics, regulatory affairs, and data management.
Drive a culture of accountability, quality, and scientific integrity across all clinical programs.
Serve on the company’s research governance committee, contributing to long-term strategy and portfolio prioritization.
Requirements / Qualifications:
Core Competencies:
As a senior member of the leadership team, the Director will shape the organization’s research portfolio, foster partnerships with industry sponsors and academic institutions, and oversee the development of a robust Quality Management System (QMS) to ensure audit readiness and sustainable research growth across the consortium.
Key Responsibilities:
- Clinical Trial Oversight
- Lead the planning, design, and execution of multicenter clinical trials within the company’s reconstructive and regenerative surgery network.
- Ensure protocol adherence, regulatory compliance, and data integrity throughout the trial lifecycle.
- Oversee site selection, initiation, monitoring, and closure in collaboration with investigators and clinical operations staff.
Requirements / Qualifications:
- MD, PhD, PharmD, or equivalent advanced degree in clinical research, life sciences, or related discipline.
- Minimum of 10 years of progressive leadership experience in clinical research operations, preferably within reconstructive surgery, wound healing, or medical device/biologics sectors.
- Demonstrated expertise in Quality Management Systems (QMS), clinical operations, and FDA/ICH-GCP regulatory compliance.
- Proven success managing multicenter trials and cross-functional research teams.
- Strong understanding of trial design, biostatistics, data management, and risk-based monitoring.
- Experience in submission processes for FDA, EMA, and IRB review.
- Familiarity with electronic data capture systems, clinical trial management systems, and audit processes.
Core Competencies:
- Strategic Leadership: Ability to set a clinical research vision aligned with the company’s mission and growth objectives.
- Operational Excellence: Skilled in translating strategy into disciplined execution, with focus on timelines, budgets, and data quality.
- Regulatory Acumen: Deep understanding of global regulatory frameworks governing medical device and biologics research.
- Quality Oversight: Commitment to maintaining the highest standards of compliance, safety, and documentation.
- Collaborative Influence: Builds strong partnerships across internal teams and external stakeholders to drive innovation and clinical value.
- Scientific Integrity: Upholds ethical research principles and promotes transparency in reporting and publication.