Head of Global Clinical Development

Summary

Provides strategic and operational leadership for global clinical development, guiding programs from IND through Phase III while ensuring scientific rigor, quality, GxP compliance, and effective collaboration with internal stakeholders, investigators, KOLs, CROs, and consultants.

• Lead and build the clinical development strategy for the company.
• Ensure that the highest quality, scientifically and medically accurate information is utilized in decision making, design, and solutioning for clinical and commercial development projects.
• Build required network of consultants and CROs to enable progression of lead programs through successful IND submission into Phase I – Phase III clinical studies.
• Work closely with the SVP Head of Global Clinical Development and Interventional Procedures to ensure a robust pipeline and the design of clinical trials for our pipeline to enable rapid progression to human proof of concept through Phase III.
• Primary responsibility for management of Phase I – III stage clinical trials.
• Managing and maintaining strong, effective relationships with our global vendors, consultants, investigators, and other external clinical trial participants to ensure that the primary goals of the clinical development programs are met or exceeded.
• Establish and manage investigator and KOL networks.
• Direct clinical development activities within the company, including management of budgets and personnel, along with a strategic vision.
• Communicating in a timely and effective manner with executive management and others, including the board of directors on clinical trial status and activities.
• Drive change and innovation though continually seeking and implementing innovative solutions; create a culture that thrives on continuous change; inspire people to stretch beyond their comfort zone; take well-reasoned risk; challenge "the way it has always been done"; change direction as required.
• Ability to build a team through influence that values organizational success over personal success; drive exceptional performance by provide ongoing coaching and feedback; identify and invest in high-performers; actively manage underperformance.
• Execute with discipline and urgency: Deliver value to the customer; closely monitor execution; drive operational excellence; get directly involved when needed; actively manage financial performance; balance speed with analysis; ensure accountability for results.
• Strong execution and commitment to Quality and GXP in the development and management of clinical trials.
• Ensure the Company complies with all applicable regulatory and legal policies.
• Guide the development and alignment of Key Medical Objectives that will enable larger Corporate Objectives.

Education/Training

• Must possess an M.D. or equivalent.
• Must have completed Interventional Radiology Post-graduate ACGME accredited Medical Education or Interventional Nephrology Advanced Training.
• Minimum 10 years of clinical practice experience.

Licenses/Certifications

• Active Medical License and Maintenance of Specialty Board Certification.
• Board Certified Nephrologist with specialization in Interventional Nephrology.

Experience

• Pharmaceutical or Device Industry experience encouraged.
• Clinical Trial experience encouraged.
• Business practice and development experience encouraged.
• Willingness and aptitude to learn new skills.

Skills/Abilities

• Excellent written/verbal communication and report writing skills.
• Proven ability to meet strict deadlines.
• Manage competing priorities and ability to be flexible and receptive to changing demands.
• Excellent organizational skills and time management skills.
• Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, PowerPoint).
• Excellent knowledge of medical terminology.
• Proven ability to follow instructions/guidelines, work independently and on own initiative.
• Excellent attention to detail and accuracy maintaining consistently high-quality standards.
• Sound judgment, independent thinking, and decision-making skills.
• Self-motivated and flexible.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Effective mentoring and coaching skills.
• Good understanding of operational metrics, productivity and initiatives.
• Demonstrate effective project management and leadership skills.