Vice President, Clinical Affairs (Remote)

Company Description

M3 is the global leader in digital solutions in healthcare. We work with a range of sectors including healthcare, life sciences, pharmaceuticals, biotechnology and charities; services provided to these sectors include market research, medical education programs, promotional programs, clinical development, job recruitment and clinic appointment services. M3 has grown by more than 20% year-on-year for the past 15 years, achieving over 1 billion dollars in revenue annually.

Founded in 2000, with start-up investment capital from Sony, M3’s mission is to make use of the internet to increase, as much as possible, the number of people who can live longer and healthier lives, and to reduce, as much as possible, the amount of unnecessary medical costs.

Key achievements of M3 Inc.

• Named in Fortune’s 2020 ‘Future 50’ list, ahead of Facebook and Amazon
• Ranked in Forbes’ 2020 Global 2000 list of the world’s largest public companies
• M3 is the only company incorporated after the year 2000 to be included in the Nikkei 225 Index
• Listed in Forbes’ ‘Asia’s 200 Best Over a Billion’ in 2019
• In 2020 M3 founded the ‘M3: Stop COVID-19 Fund’ and pledged one billion yen to support COVID-19 related initiatives

M3’s legacy lies in the power of trusted physician platforms. Around the world, M3 organizations leverage these highly engaged digital communities to deliver medical education, job placement, and market research, to improve global patient outcomes.

Due to our continued growth, we are hiring for a Vice President of Clinical Affairs at Wake Research, an M3 company.  This position is remote with some travel involved. 

About the Business Division:

M3 Wake Research, Inc. is one of the largest independent clinical research site services companies in North America. M3 Wake Research is an integrated network of premier investigational sites working closely with and meeting the needs of the global biopharmaceutical, biotechnology, medical device, pharmaceutical industry, and clinical research organizations. M3 Wake Research has its proprietary patient database of potential clinical trial participants—men and women, children and adults, across all ethnicities—for all kinds of adaptive and other types of trial designs. Conducting studies since 1984, we have a combined subject database of more than 2 million.

M3 Wake Research has 26 owned and managed research sites across 9 states in the US and continues to grow. As of today, our board-certified physicians have completed more than 7,000 successful clinical trials. Clinical trials at our site are always completed on time and with accuracy; we consistently exceed sponsor expectations for integrity, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Our approach is uncompromising – each study conducted at our site is carefully planned and executed according to regulations with superior quality.

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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