Director, Clinical Science

Location
Burlingame, California, United States
Posted
Sep 14, 2020
Ref
4126482003
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
SUMMARY OF ROLE:

The Director, Clinical Science is a critical member of the Clinical Affairs team. The candidate is responsible for designing clinical studies important for the development and commercialization of our in-vitro diagnostic tests. In addition, the candidate will engage with emergency, critical care, and general practice key opinion leaders and community physicians to identify areas of unmet need and gaps in evidence in order to define the studies that need to be executed. 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 and Regulatory Affairs). The candidate will be the liaison to Product Development, Computational Biology, Machine Learning and Program Management. All activities will be coordinated and conducted in close association with Design Assurance and Product Management.

This position will be based out of Inflammatix headquarters in Burlingame, California, reporting to the Chief Medical Officer.

PRIMARY RESPONSIBILITIES:
  • Work with the Clinical Affairs teams to design, implement, interpret, report and publish clinical studies for regulatory clearances. Identify suitable academic partners, external laboratories and clinical sites to participate in clinical studies
  • Assist Product Development with assay design, design of performance verification and analytical study design and assay and instrument readiness for clinical trials
  • Provide medical/scientific input into and assists with the preparation of regulatory submissions. Prepare and provide responses to questions or requests from regulatory agencies
  • Provide medical expertise and leadership to Clinical Affairs functions - Clinical Operations, Data Management, Biostatistics, Medical Affairs and Regulatory Affairs - as well as Quality/Design Assurance, Product Development and Product Management groups
  • Identify areas of unmet medical need for diagnostics. Devise the medical strategy for new products and articulate their potential medical value. Help identify and evaluate promising new biomarkers. Explore and define potential clinical utility for company products
  • Provide medical opinions and health hazard analyses for product safety. Serve as a member of the Safety Board
  • Ensure handover of clinical activities to the Medical Affairs team in support of post-launch activities including commercialization
  • Assist Medical Affairs in guidance to the Product Management teams to ensure marketing and promotional materials are both scientifically accurate and medically sound
  • In collaboration with Medical Affairs and Product Management organize conference symposia, advisory panels and affiliate trainings
  • Review publications by Inflammatix and external collaborators for scientific and medical content
  • 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

QUALIFICATIONS:
  • MD or equivalent. PhD, PharmD or other backgrounds with strong clinical experience are also acceptable
  • 3+ years clinical experience, with preference to primary care, urgent care, emergency medicine, infectious disease or intensive care settings

KNOWLEDGE, SKILLS, AND ABILITIES:
  • Proven ability to design and conduct clinical trials, critically monitor study results and review the resulting study reports
  • Diagnostic laboratory experience, particularly in molecular and point-of-care testing
  • Experience within the in-vitro diagnostics, medical device or pharmaceutical industry, with a track record of FDA clearance or approval based on clinical trials
  • Thorough understanding of product development process for in-vitro diagnostics
  • Proven track report in writing manuscripts for high impact peer-reviewed journals
  • Excellent organizational, communication, and project management skills
  • 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

COMPENSATION AND CLASSIFICATION:
  • Classification: Full-time position located at our Burlingame, California headquarters
  • Compensation: Competitive and commensurate with experience; including strong equity package
  • Benefits: Medical, dental, and vision; 401(k) and more