Sr. Director of Clinical Research

Description

Company Overview:
OrthoCor Medical is a business unit of Caerus Corp and is headquartered out of Blaine, MN. At Caerus Corp, we are committed to fostering a dynamic and inclusive workplace that values collaboration and innovation. We believe in empowering our employees. If you are looking for an exciting career where you can make an impact, we would love to hear from you! 

Position Summary:

The Director of Clinical Research is a leader who takes responsibility for all aspects of Clinical Affairs in the coordination and implementation of clinical research, Investigator-Initiated and Registry studies from start to finish. This individual will provide guidance and direction to other clinical team members.

This will be a key position providing Medical Leadership for the Clinical Research Team. The position carries operational and strategic level responsibilities for providing clinical development, scientific and medical input, oversight, and leadership for OrthoCor Medical’s clinical research programs, including both early-stage clinical development as well as mainstream post market clinical studies. Strategic accountabilities include design and execution of clinical research studies and publications.

The role also incorporates higher responsibilities in Senior Management and Regulatory interactions, including strategic input at wider cross-functional meetings for the company.

Duties and Responsibilities:

• Direct and implement clinical research plans and programs according to best practice principles.
• Oversee the integration of clinical research into the company’s broader strategic, regulatory, and product development initiatives to ensure alignment with business objectives and industry’s best practices.
• Lead the development of Clinical Protocols to meet Clinical Development Plan (CDP) objectives.
• Serve as Study Director and drive execution of a study from protocol concept to final report including interpretation of clinical data.
• Serve as the Medical Monitor for a study or clinical program, reviewing and monitoring study safety data.
• Implement strategies to identify, monitor and resolve clinical/program trial issues.
• Serving as the clinical and medical expert, you will provide strategic direction to all project teams, ensuring the organization and execution of Advisory Board meetings.
• Engage with and collaborate with the Clinical Endpoint Committee (CEC), Data Safety Monitoring Board (DSMB), and Key Opinion Leaders (KOLs) to gather insights on program strategy and scientific guidance.
• Interpret study data and developing integrated summaries for safety and efficacy.
• Contribute clinical expertise and content to regulatory documents (e.g. briefing books, NDAs, etc.)
• May represent the Clinical team in discussions with healthcare and payer authorities.
• Responsible for resources and financial oversight.  Establish key deadlines and project milestones, allocate budget effectively to target opportunities, and review deliverables from third-party contractors, consultants, and vendors to ensure quality, approve invoice payments and resolve issues.
• Lead by example to encourage others to prioritize personal and professional development.

Qualifications

Minimum Qualifications:

• Bachelor's degree in a relevant field Life Sciences, Engineering, or Medical Sciences.
• 7 - 10 years of experience in clinical research or clinical development, with at least 5 years in a leadership role.
• Working knowledge of FDA regulations, GCPs, and current industry practices related to the conduct of clinical trials
• experience in clinical trial management, including design, execution, data analysis, and final reporting.
• Experience in and post-market research preferred.
• ACRP or SOCRA certification preferred.
• Travel up to 30%.

Compensation:
Caerus Corp provides the following information about compensation for this position:

• Salary Range: $142,000 – $200,000 per year.
• Benefits:
  • Health, dental, vision, basic life, and AD&D insurance
  • 401(k) retirement plan with employer match
  • Paid time off (PTO) and holidays

The salary range is based on several factors which will vary based on position.  These include labor markets and, in some instances, may include but not limited to education, work experience, scope and responsibilities of position and geographic location.

Work Environment & Culture:
At Caerus Corp, we value a diverse and inclusive workplace where employees feel empowered to contribute, learn, and grow.

Equal Opportunity Employer:
Caerus Corp is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business need.

Why Join Us?

• Opportunity to work with a dynamic team and make a meaningful impact.
• Competitive salary, benefits, and opportunities for professional development.
• A commitment to fostering a safe, productive, and collaborative work environment.

Caerus Corp. headquartered in Blaine, MN is a developer, manufacturer, and marketer of innovative medical devices for both the human and the veterinary medical space.  Our brands include: OrthoCor Medical, Animal Ortho Care, Red Fox Innovations and New Options Sports.

Salary : $142,000 - $200,000