Company Overview

This is a company that uses AI to improve patient outcomes.

Position Title: Director / Senior Director / Vice President, Clinical Affairs (JO#2109-5657)

Territory: Various

The  Director of Clinical  Affairs will lead and execute a key clinical trial, the first of its kind in the focal therapy field. 

S/he will build and manage clinical staff as well as external vendors. This person contributes directly to the team’s and the trial’s success. 

Reports to the COO.

Essential Duties and Responsibilities

  • Implement and execute a multi-site RCT on time and on budget
  • Manage the process of screening, qualifying, selecting, and contracting with investigators, sites, and vendors required for the clinical trial.
  • Select and develop software and database to execute the clinical trial.
  • Responsible for team selection, training, and development.
  • Obtain necessary clinical trial approvals from IRBs and regulatory bodies. 
  • Ensure studies are on track for site initiation, patient recruitment, and enrollment, and take corrective actions where necessary to address issues.
  • Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications. 
  • Develop SOPs and work instructions to assure internal files and clinical study files conform to Good Clinical Practice regulations and standards.
  • Ensure adherence to protocols and compliance with regulatory (FDA/ISO/GCP) guidelines as well as SOP procedures.
  • Identify clinical training needs and develop training materials for in-house and clinical site use.
  • Develop and implement a publication strategy.

Qualifications (Education & Experience)

  • Master’s degree in a relevant health profession, science, or field. A doctoral degree (PharmD, PhD, MD, PA, DNP) is preferred.
  • Strong track record in successfully implementing and executing medical device clinical trials.
  • Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ISO, & FDA guidelines and applicable international regulations.
  • Strong, hands-on manager with experience in managing KOLs, Clinical Affairs staff, CROs, Core Labs, Data Management, Biostatistics, and Medical Affairs Safety Reporting. 
  • Knowledge of electronic data capture systems and web-based clinical trial management tools.
  • Excellent interpersonal, written/verbal communication & organizational skills with attention to detail.
  • Collaborative team player.
  • Ability to work within a fast-paced startup environment.
  • Willing and able to travel for trial implementation, as required (up to 30%).

Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.

Learn more at www.trinetpharma.com.

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