Director of Genomics
The candidate should have previous experience leading the development and validation of a diagnostic tests. Candidates with a strong immunology background and knowledge of blood based genomics are preferred. The candidate will be directing a team of molecular biologist, computational biologists, and clinical scientists in the design and development of direct-to-patient genomic tests. The candidate must be hands-on and comfortable working in a fast-paced and dynamic company. The ideal candidate will be very knowledgeable in US and international clinical regulations. Excellent writing, verbal communication and organizational skills are critical.
Role and Responsibilities
- Reports to the CEO.
- Set strategic direction and lead new genomic test development efforts.
- Develop and maintain professional relationships with academic, Key Opinion Leaders (KOLs) and community-based physicians to assure good clinical input to DxTerity Diagnostics product development process, marketing, and field sales force.
- Author and/or work with others to develop publications based on the results of the clinical studies trials.
- Represent the company and present at conferences and to customers.
- Provide updates and status reports to senior management on a regular basis; report on performance against plan.
- Manage the budget for new test development efforts. Ensure overall operation is within the approved budget and timeline.
- Work with Product Development to ensure effective transfer of new tests
- Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with patients and physicians.
- Interface with departments within and outside of DxTerity including Reimbursement, R&D, Regulatory Affairs, Marketing, and Sales.
- Manage staff and outside partners/service providers.
Education, Certification/Licensing and Experience Required
- Understanding of immunology and blood based disease identification preferred as well as a strong understanding of computational biology
- Masters, PhD or MD degree in related field preferred
- Computational biology and/or bioinformatics expertise
- Experience in molecular diagnostic product development with at least five years of hands-on managerial experience.
- Strong knowledge of FDA regulations and internal regulations.
- Knowledge of and experience in experimental design.
- Basic understanding of statistics and statistical methods.
Must be proficient in written and verbal communication in the English language.
- Exhibit ethical behavior.
- Strong communications skills
- Ability to work in an interdisciplinary team environment
- Strong analytical skills
- Solid time management skills
- Ability to routinely interact with all levels of the company (i.e. CEO, President, VPs, Directors, Managers, Engineers, Supervisors, Technicians, Operators)
- Organizational, planning and detail follow-up skills.
- Ability to understand complex scientific concepts.
Must be consistent with college level education. Knowledge of basic statistics relevant to interpretation and analysis of scientific data.
Good investigative techniques for problem solving, judgment and decision-making skills are required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench, or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may occasionally be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Please send resumes and cover letters to firstname.lastname@example.org