Head Clinical Research

Do you want to help prevent blindness on a global, massive scale? 

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Oivi is a fast-paced medtech startup with offices in Oslo, Norway and Bangalore, India. We have strong backers and funding, an experienced research & development team, and a product in commercial pilots.

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Now the company is scaling its activities on commercial, technical, regulatory, operations and manufacturing fronts, and we are looking for a Head of clinical research, who can help facilitate this growth, creating processes, structure and systems, offloading and working closely with the CEO and the rest of the leadership team.

Oivi is an ambitious and young medtech company developing a technology to overcome a huge challenge that impacts the lives of millions of people with diabetes. Our vision is to bring to market a low-cost artificial intelligence enabled fundus camera and automated diagnostics platform for early screening of Diabetic Retinopathy. We are a startup based in Norway and India. We are trying to achieve what nobody has done so far and we are trying to get there with high speed. Want to join us?

Oivi is looking for uniquely talented individuals who combine skills and experience with drive and passion for what they do. You must be self-driven and should have the ability to interact and engage with cross-cultural teams.

• Operational management and the oversight of clinical studies. Successful execution of clinical study from the protocol concept through the clinical study report, ensuring completion of study deliverables is the core responsibility.
• Provide strategic leadership and direction to relevant stakeholders. The individual will lead the timely planning and execution of clinical strategies and roadmap, drive the full spectrum of the clinical execution from the design phase to close-out, while collaborating closely with internal and external subject matter experts. 
• Establish and maintain professional and credible relationships with key opinion leaders and academic centers; participation in scientific congresses, co-ordinating advisory boards, round-table meetings and discussion forums.
• Manage strategic study operations including study sites and tracking systems for regulatory submissions, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
• Excellent management skills, an execution mind-set and the ability to coach and mentor a team of high performers.
• Interface with representatives from key functional groups including Management, Product Development/R&D, Regulatory Affairs, Quality Assurance, and Operations to set operational direction and strategy for clinical study activities
• Establish a team to align with organizational needs in planning and executing a diverse study portfolio and publications for today and future success
• Builds continuing professional relationships with key opinion leaders in the industry and healthcare system
• Provide medical/scientific input into marketing strategy and key commercial initiatives. Review and preparation of promotional material.

This is an exciting opportunity for the right candidate to shape the role and make a meaningful impact on the company's growth. The position can be based at our office in Bangalore, India, or Oslo, Norway. We encourage applicants from both regions to apply. You will be offered shares in the company and will be part of Oivi's leadership team, reporting to the CEO. The salary is negotiable and dependent on experience.

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Qualifications:

• PhD/MBBS in biological sciences or related medical/scientific field with a minimum 5-year leading clinical studies 
• 3+ years of clinical project management experience with global clinical studies. 
• Proven track record of successfully building and managing global teams, with an emphasis on organizational and operational excellence
• Experience in all study phases desired 
• Strong regulatory knowledge, including Good Clinical Practices (GCPs) 
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability. 
• Excellent communication (written and verbal) and presentation skills along with leadership qualities. 
• Knowledge of global clinical trial management in a fast paced environment. Ability to assemble a plan and execute on the details.
• Proficient with MS Office Suite (Excel, Word and PowerPoint) 
• Proven successful experience managing Class II preferably diabetes/ device studies
• Data-driven decision-making mindset

At Oivi, our goal is to provide our people with the best possible support, resources and environment to grow. Our culture is entrepreneurial, nurturing and fun. We work hard because we love what we do. Developing a product that has an impact on millions of people and their families is what motivates us everyday to keep chasing our vision. 

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We think you will like to work with us if you appreciate:

• An environment where your opinion matters and where you are not micromanaged. 
• Being a team player while taking your individual responsibility.
• The importance of work-life balance and flexible working environment.
• A multicultural and diverse team both in experience and background. 
• Team off-sites, lunch/coffee chats and a wide range of social and team bonding activities.
• A great sense of humour.
• Working for a company that works towards a cause that positively  impacts the lives of people and families all over the world.

Oivi is committed to equal opportunity employment, encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard for personal identity.