Director, Clinical Research

Clinical Redwood City, California


Description

The Director, Clinical Research position will oversee the management of the company's global clinical trial activities, including development and maintenance of the company's clinical trial databases and facilitation of cleaning of data for analyses. The Director, Clinical Research will be responsible for directing and supervising all aspects of the research trial process. This person will have hands-on responsibility for several trials, worldwide, in a small fast paced clinical research organization.

Job Responsibilities:

  • Direct and supervise all aspects of the clinical trial process, ensuring compliance with GCP requirements, and FDA and other applicable international regulations.
  • Oversee day-to-day activities of clinical research personnel. Provide leadership and mentoring for the team.
  • Assist in the development of study protocols, statistical analysis plans and design of case report forms.
  • Development of data management plans, data entry and data handling guidelines/SOPs, and other study support documentation.
  • Oversee the design of clinical databases, including validation of the database design, programming of edit-check procedures, direct data entry processes, coding of adverse events, maintenance of coding dictionaries, locking/freezing databases, and management of data extracts into SAS datasets for analysis. Includes development and oversight of database test plans, specifications, and summary reports. Manage and/or participate in user-acceptance testing and database validation.
  • Oversee the management of all data output for internal review, trial Steering Committee, Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) meetings, Core Laboratories, monitoring, production support and regulatory efforts.
  • Track and report on study data metrics.
  • Oversee study Steering Committee activities – plan meetings, develop content for review, ensure guidance is obtained when necessary for study management.
  • Site management including oversight of site initiation, site personnel training and documentation, monitoring, regular requests for data/enrollment.
  • Tracking all clinical activities conducted by HeartFlow to ensure proper documentation is in place before HeartFlow receives and processes data.
  • Develop and maintain clinical study schedules and budgets.
  • Manage the Clinical Leadership Team process, including review and support decisions for investigator-initiated studies.
  • Some travel required; will occasionally conduct site visits, attend investigator meetings or vendor visits/audits.

Skills Needed:

  • Personnel management experience
  • Experience directing and leading multinational studies and prospective randomized clinical trials of medical technologies pre-approval and post-approval
  • Experience directing and leading large post-market registry studies
  • Core Laboratory and Clinical Events Committee management experience
  • Demonstrated experience with electronic data capture (EDC) systems, software testing and validation
  • Demonstrated ability to learn quickly and work in cross-functional teams
  • Experienced in leading global teams
  • Very strong communication, documentation and organization skills
  • Strong computer literacy and expert in MS Office applications
  • Knowledge of CH GCP / ISO 14155 and FDA human clinical research requirements
  • Working knowledge of MHLW / PMDA human clinical research requirements
  • Working knowledge of biostatistics used in clinical research

Educational Requirements & Work Experience:

  • Bachelor’s degree
  • Demonstrated 5 years minimum experience in EDC methods. Demonstrated 10 years minimum experience in a clinical research role(s).
  • Experience in cardiovascular clinical research a plus
  • Experience in trial design and implementation a plus

Company Summary

HeartFlow is an exciting, revolutionary, medical software start-up that has received international recognition for exceptional strides in healthcare innovation. We are changing cardiovascular healthcare through improvements in the accuracy of non-invasive tests for Coronary Artery Disease, the most common form of Heart Disease and the number one killer of men and women in the United States. HeartFlow operates as a SaaS business that processes standard Computed Tomographic (CT) imaging to generate 3D models of patients’ coronary arteries for physicians’ use. HeartFlow is a VC-backed, pre-IPO company that received FDA clearance in 2014. We are based in Redwood City with an existing and expanding presence in Europe and Japan.

www.heartflow.com

HeartFlow, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.

Physical Demands of the Job:

  • Up to 25% travel (domestic and international)

Positions posted for HeartFlow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.