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Vice President Clinical Trials

Vice President Clinical Trials

MISSION
 
The mission of the Vice President Clinical Trials is to design and execute ARC’s clinical strategy to maximize market access for ARC’s medical devices for the reduction of surgical adhesions.
 
YOU
 
• Are an entrepreneur in a VP Clinical’s body
• Love hands-on writing clinical protocols and running clinical trials
• Have a fearless personality and a yearning to change the world
• Are passionate about preventing surgical adhesions
• Desire to have a substantial, direct impact on the success of the products you develop and the
company you work with
• Perform remarkably or fail big, rather than perform adequately
 
OUTCOMES
 
• Within the first 90 days, determine the optimal global strategy and designs for clinical, post-market and registration trials, including clinical and economic outcomes, based on the requirements of patients, surgeons, hospitals, regulators, payers, companies interested in acquiring ARC or distributing ARC’s products, and any other relevant stakeholders.
 
• Within the first 90 days, assist our VP Regulatory to initiate the regulatory process for clinical trials in three territories for our first-in-human clinical trial and at least three additional trials.
 
• Initiate clinical trials:
o Within the first 180 days, plan, design (including study protocols, investigators, key opinion leaders, clinical trial CROs), implement and initiate our first-in-human clinical trial including enrolling and treating the initial subjects – and then run this trial through to completion.
o Within the first 270 days, plan, design (including study protocols, investigators, key opinion leaders, clinical trial CROs), implement and initiate our second-in-human clinical trial including enrolling and treating the initial subjects – then run this trial through to completion.
 
• Ensure maximum reimbursement and adoption of ARC’s products by:
o Obtaining strong safety, efficacy, effectiveness and health economic data;
o Providing a compelling clinical value proposition and clear healthcare economics;
o Working with market access and marketing folks to develop and provide the most
effective message to patients, payers, hospital administrators, surgeons, researchers,
companies interested in acquisition or distribution, and any other relevant stakeholders.
 
• Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with surgeons.
 
FLEXIBLE WORK WEEK
 
This is a part-time position of 3 full days or 5 approximately half days per week. Increased time may be added during busy periods such as year-end.
 
REQUIRED DESIGNATIONS AND EXPERIENCE
 
• BSc or higher in applicable degree e.g. Nursing, Life Sciences, Biotechnology, Chemistry
• Medical Degree an asset
• 10 years combined hands-on experience running clinical trials, including managing teams and
clinical contract research organizations
• Must have written multiple investigator brochures & pilot and phase 1 medical device or
pharmaceutical protocols
• Hands-on experience designing and managing multiple first-in-human medical device or
pharmaceutical pilot and Phase 1 clinical trials
• Preferably clinical trial experience is in surgical settings for medical devices and/or
pharmaceuticals
• Fluent in English with excellent writing skills
• Working knowledge of medical Chinese, Japanese &/or German is an asset
 
HOW TO APPLY
 
• Tell us in eight sentences or less why you’re interested in ARC and how your past
accomplishments show what unique contributions you can make to our Team, including how
you will rapidly initiate and complete the work to meet the Outcomes outlined above.
• Email your cover letter and CV in pdf to jobs@arcmeddev.com and include the name of this
position in the subject heading.
• Due to the anticipated volume of responses, we will contact only those candidates who most closely match our requirements.
 
WHY OR WHAT IS ARC MEDICAL DEVICES INC.?
 
ARC is developing and commercializing novel, first-in-class solutions to prevent post-surgical adhesions – which if not prevented cause pain & suffering, organ dysfunction, infertility, and death; and for which there is a dire unmet medical need.
Our products are non-viscous, liquid, polysaccharide-based medical devices. Our preclinical data in numerous surgical adhesion models show that our product flows throughout the entire surgical site and reduces the formation of surgical adhesions throughout the entire surgical site. We’ve recently built a manufacturing facility & QA laboratory; and are implementing our quality management system now (ISO13485). We will initiate first-in-human and follow-on clinical trials in the near-term.
 
WE
 
• Work to positively transform the health of millions of surgery patients
• Care more about your ability to lead and pioneer than your experience
• Are building a start-up: a normal work week is 60 hours
• Are implementing efficient systems in the midst of scale-up chaos
• Are not afraid to make mistakes
 
WHY WORK AT ARC MEDICAL DEVICES INC.?
• Mission: We are doing something super-important that no one else is going to get done: using our novel, liquid medical device we are reducing the formation of surgical adhesions throughout the entire surgical site.
• People: We have a superstar team that is passionate about improving their own & others’
health and is fun to work with (also a bit goofy). Every member of our team is prioritized,
driven, trustworthy, self-improving, smart, creative, and efficient. Our team is built of diverse international people across various disciplines – all of whom enjoy the outdoors, be it hiking, trail-running, camping, kayaking, kiteboarding, snowboarding, downhill skiing, cross-country skiing or other outdoor activities.
• Family: As part of our hiring and post-hiring processes – we ensure that ARC is the correct fit for our team members’ families.
• Fun: Our entire team has lunch together on Fridays; occasionally we have Friday Beer O’Clock; and we also have a ‘celebration day’ after achieving an aggressive milestone – including activities like go-kart racing, mini-golf, and beer brewing.
  
EQUAL OPPORTUNITY EMPLOYER
 
We are an equal opportunity employer and evaluate applicants without regard to race, colour, national origin, culture, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
 
TRAVEL REQUIREMENTS
 
We anticipate that approximately 25 to 50% of the time for this position will include international travel.
 
LOCATION
 
We are in Richmond, British Columbia, Canada – right beside Vancouver. From our facilities to the Vancouver International Airport is about a 10-minute drive; and to the heart of downtown Vancouver is about a 30-minute drive.