Employer: iFirst Medical Technologies
Job Title: Chief Medical Officer
Location: Honolulu, Hawaii or West Coast USA
Hours: 40 hours plus, per week
Start Date: 3-1-17
Term: Contract to start
iFirst provides radical improvements to existing diagnostic and applications. This approach allows iFirst to enter markets with minimal risk and quick FDA approval. Our diagnostic platform focus on high impact and large markets. Our first product will target the second most common diagnostic market, blood coagulation.
As a member of an experienced senior management team, translate the corporate strategy of the company into an integrated clinical strategy for novel diagnostic assays/products leading to the regulatory submission and approval of product candidates.
- Actively participate on device program teams to ensure sound human factors principles are considered and implemented
- Create and communicate project plans, tasks and deliverables and manage time to meet project deadlines
- This includes reporting pertinent information at key milestones through clear, concise oral and written communications
- Applies hands-on skills in usability testing and measurement in areas of hardware, software, and disposable products
- In partnership with other R&D teams, develop product prototypes to explore and validate user interfaces and demonstration prototypes
Position Description / Duties
Desired Qualifications / Experience
- D. (certified in the field of oncology and/or neurodegenerative disease) with a minimum of 6-10 years in the pharmaceutical/biotechnology industry.
- Should be able to communicate with KOLs and advisors as a peer.
- Be excited and motivated to work in the emerging field of molecular diagnostics and personalized medicine.
- Be motivated by working in a smaller, high-growth company environment that prizes individual initiative and lack of large company structure.
- Experienced, self-motivated individual with sound analytical skills and a record of achievement in successful IND(s) and/or NDA/BLA(s) or equivalent; experience in filing and getting diagnostic products approved is a plus.
- Have a solid understanding of personalized medicine and existing as well as emerging new treatments in the field of oncology and be able to support the company in making the right strategic choices how to further develop its platform.
- Successful track record in drafting and implementing clinical trial protocols in oncology. Experience integrating biomarkers and companion diagnostics in clinical protocols is a plus.
- Knowledge of GCP and regulatory guidelines and experience with compliance issues addressed by health authorities, preferably in the US and EU.
- Demonstrated leadership of successful teams with a history of developing a culture of teamwork, collaboration and communication.
- Demonstrated understanding of strategic commercial drivers of oncology products.
- Ability to work and flourish in the culture of a small biotech company is a must.
- Good conflict resolution and problem solving skills.
- Good time management, the ability to handle multiple, competing tasks and strong decision making.
- Excellent written and verbal skills and the ability to communicate clearly, concisely and effectively.
- Experience in GU malignancies, especially prostate cancer would be a plus.