Job Description

Mission of the Role:

Reporting to the COO, the VP of Clinical Affairs will be responsible for providing strategic and technical clinical leadership and act as a full partner with other groups including Clinical Operations, Marketing, Business Development, Regulatory Affairs, etc. Will supervise Investigators that are exempt and non-exempt employees of M3 Wake Research across the network (with the exception of CA). Review study opportunities for across network implementation. Participate in business development and site acquisition activities as needed.

Essential Duties and Responsibilities:

• Serve as Clinical Affairs expert for internal and external stakeholders
• Provides expert clinical and scientific support to multiple departments and interdepartmental teams
• Develops relationships with key opinion leaders consistent with the company’s strategic goals
• Develops and executes Clinical Affairs initiatives that align with the company’s goals
• Assists marketing team in revision of promotional material to ensure medical and scientific accuracy
• Manages Investigators to ensure their success in executing clinical trials including training and mentoring
• Supports business development activities including conference attendance as needed
• Supports clinical site acquisition due diligence as needed
• Provides strategic leadership for the growth of the clinical expertise and business of the site network
• Provides or coordinates Research Rounds meetings for experiential training for Investigators
• Supports quality initiatives across the organization
• Mentor Investigators on GCP compliance and quality escalations
• Interact with Sponsors regarding enrollment and protocol design as needed

Qualifications

Requirements:

• MD required
• 10+ years of clinical, scientific or clinical affairs experience
• Experience with CRO/CRA management and overall life-cycle of clinical trials
• Must possess strong leadership, influencing skills, having the ability to guide others with authority
• Strong project management skills
• Excellent oral and written communication skills, with the ability to discuss scientific/technical data and regulatory requirements with senior management and other stakeholders
• Ability to read, analyze and interpret common scientific and protocols and other related materials
• Ability to be self-motivated, work independently and balance multiple priorities in a fast-paced FDA regulated environment
• Strong organization and planning skills with an attention to detail and accuracy
• Ability to effectively present information to top management and/or the scientific community
• Prior experience as an Investigator preferred

Additional Information

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:

• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

*M3 reserves the right to change this job description to meet the business needs of the organization

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