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Director (Senior Director) of Clinical Science

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Inflammatix is a pioneering molecular diagnostics company that is reimagining diagnostics by “reading” the patient’s immune system to deliver rapid results that improve patient care and reduce major public health burdens. The company’s groundbreaking computational biology techniques produce mRNA signatures for diagnosis, prognosis, and treatment-response. It is these mRNA signatures -interpreted by machine learning driven algorithms- that enable Inflammatix to ‘read’ the immune response.

The Director (Senior Director) of Clinical Science will become a critical member of the Clinical Affairs team. Reporting into the Chief Medical Officer, this individual will be responsible for designing clinical studies for the development and commercialization of its in-vitro diagnostic tests. In addition, the candidate will engage with emergency medicine, critical care, and other key opinion leaders to identify areas of unmet medical needs and gaps in evidence. The Director of Clinical Science will also engage with these physician specialties and their societies to integrate study findings into protocols and guidelines.

The candidate will work cross-functionally within Inflammatix, collaborating with all Clinical Affairs functions (Clinical Operations, Data Management, Biostatistics, Medical Affairs). The candidate will be the liaison to Regulatory Affairs, Product Development, Computational Biology and Machine Learning teams. All activities will be coordinated and conducted in close association with Quality and Product Management departments.

Although the position will be based in Sunnyvale, CA, it is understood that the Director of Clinical Science will be allowed to work remotely (if desired), with occasional visits to the company headquarters. Initially, the Director of Clinical Science will have no direct reports; however, will have the opportunity to add team members in the future. The Director of Clinical Science will have the opportunity to pave the way in launching a truly impactful and disruptive technology into the marketplace and patient care. Inflammatix is a startup company with great technology with the fun atmosphere of an earlier stage company, high cultural standards and a very sound financial foundation. The Director of Clinical Science will prove to be a pivotal addition to the growing world-class team that is being assembled.

PRIMARY RESPONSIBILITIES:

Work with the Clinical Affairs teams to design, implement, interpret, report and publish clinical studies for both pre-market and post-market studies. Identify and help collaborate with suitable academic and non-academic partners and clinical sites to participate in clinical studies
Draft manuscripts to communicate medical and scientific messages in peer-reviewed clinical study publications, review articles, and develop posters and oral presentations for key scientific meetings
Review publications by Inflammatix and external collaborators for scientific and medical content and run internal and external manuscript review processes
Provide medical/scientific input into and assist with the preparation of regulatory submissions
Write protocols for site implementations of cleared products, and help Medical Affairs drive success in those programs
Provide medical expertise to other Clinical Affairs functions - Clinical Operations, Data Management, Biostatistics, and Medical Affairs
Identify areas of unmet medical need for innovative diagnostics. Support the Business Development/Strategy teams to devise the medical strategy for new products and articulate their potential medical value
Assist Product Development with new test design, and design of performance verification and analytical studies
Provide medical opinions and health hazard analyses for product safety
Serve as a member of the Safety Board
Serve as a medical leader at Inflammatix, keeping the company abreast of advances in clinical medicine and health systems, as they relate to (point of care) diagnostics

MINIMUM QUALIFICATIONS:

MD or MD/PhD preferred, PhD or PharmD with relevant experience accepted
Academic clinical research experience is highly desired
At least 3 years relevant experience, with preference to primary care, urgent care, emergency medicine, infectious disease or intensive care settings
At least 3 years of scope experience within the in- vitro diagnostic device industry preferred, with device or pharma experience acceptable

KNOWLEDGE, SKILLS & ABILITIES:

Proven ability to design and conduct clinical trials, critically monitor study results, and review the resulting study reports
Diagnostic experience, particularly in molecular and point-of-care testing is a plus, but not mandatory
Thorough understanding of product development process for in-vitro diagnostics
Proven track record in writing manuscripts for high impact peer-reviewed journals
Experience in interfacing with key opinion leaders including physicians, clinical laboratorians, and other healthcare personnel to build and foster global relationships
Ability to travel domestically and internationally (10-20%) of the time
The preferred candidate will be agile, dynamic, innovative, and collaborative with demonstrated technical development skills
Must be a self-starter and capable of working productively from home and within an entrepreneurial environment
Excellent organizational, communication, and project management skills
Team player with demonstrated ability to influence and drive cross-functional teams; excellent teamwork and collaborative capabilities in a matrixed organization
Excellent professional communication skills, including verbal, written, and presentation
Strong scientific, analytical, problem solving and trouble shooting skills
Ability to develop strong relationships with Investigators, thought leaders, and other parties important to Inflammatix’s image and future success

COMPENSATION AND CLASSIFICATION:

Classification: Full-time
Compensation: Competitive and commensurate with experience; includes equity package
Benefits: Medical, dental, and vision; 401(k), generous leave and more
Location: Remote (U.S)
The base salary range for this position is $210,000 - $280,000 per year which represents the low and high end of the anticipated salary range for this exempt position.
- Please note that actual offer will vary based on factors including, but not limited to the candidate's geographic location, job-related knowledge, skills, and experience among other factors including internal equity. As such, there is the possibility that the final, agreed-upon base salary may be outside of the lower or upper end of the range. Please also note the compensation range listed is just one component of the company's total rewards package. A bonus and/or long-term incentive units may be provided as part of the total compensation package, in addition to the full range of medical, financial and/or other benefits, dependent on the level and position offered.
- U.S. employees are offered medical, dental and vision insurance, as well as access to HSA, FSA, commuter, LTD, STD and basic life insurance. Employees are eligible to enroll in our company 401k plan and employer match. Employees accrue up to 15 paid vacation days, 7 paid sick days and 10 paid holidays per calendar year. Inflammatix U.S. offices are closed for winter break each year between Christmas and New Year’s Day and the company offers this time as additional paid time off for U.S. salaried/exempt employees.

Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable law.

Notice to Agencies: Our internal Talent Acquisition Team manages all career opportunities. Agencies and independent recruiters must be approved as a vendor by the Legal and Talent Acquisition teams at Inflammatix before submitting candidates (for any current or future positions) to any employee of Inflammatix. We do not accept unsolicited resumes or profiles from agencies or independent recruiters under any circumstances. Inflammatix will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume or profile. Please do not contact Inflammatix employees directly. Compliance with this request will impact our decision to engage or work with you or your agency and/or representatives in the future.

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Inflammatix is an equal opportunity employer in the United States. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee, including supervisors and co-workers. Per applicable law, we prohibit discrimination against any applicant or employee based on any legally-recognized basis, including, but not limited to: race (including, but not limited to, hair texture and protective hairstyles such as braids, locks, and twists), color, religion, religious creed (including religious dress and grooming practices), national origin, ancestry, citizenship, physical or mental disability, medical condition (including cancer and genetic characteristics), genetic information, marital status, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender (including gender identity and gender expression), age, sexual orientation, veteran and/or military status, protected medical leaves (requesting or approved for leave under FMLA or CFRA, or any similar applicable state or local law), domestic violence victim status, political affiliation, or any other status protected by federal, state, or local laws. Inflammatix is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment.

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Director (Senior Director) of Clinical Science