PRINCIPAL INVESTIGATOR - ASSOCIATE MEDICAL DIRECTOR

Company: Pharmaceutical Product Development, LLC
Location: Austin
Posted on: February 21, 2021

Job Description:

Principal Investigator - Associate Medical Director Job Description We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.---You will be joining a truly---collaborative and winning culture as we strive to bend the time and cost curve of delivering---life-saving therapies to patients.

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks.

As an Associate Medical Director you will provide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:
Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities.

Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

Essential Functions:
Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.

General Support:

• Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
• Adheres to client SOPs/directives and project specific WPDs for assigned projects.
• Adheres to PPD's corporate policies and SOPs/WPDs.
• Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provides therapeutic training and protocol training on assigned studies, as requested.
• Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete. Clinical Trial Support:
  
  • Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
  • Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
  • Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
  • Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns. Marketed Products Support:
    
    • Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
    • Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted. Job Qualification Education and Experience:
      MD or equivalent required. Active medical licensure preferred. Candidates should have at least one of the following:
      
      Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years); Or
      
      Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or
      
      Direct experience in safety/Pharmacovigilance (comparable to 2 years).
      
      In some---cases---an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
      
      Knowledge, Skills and Abilities:
      
      • Therapeutic expertise across one or more medical specialty or sub-specialties
      • Strong decision-making, problem solving, organizational skills and analytical skills
      • Excellent oral and written communication skills
      • Working knowledge of relevant safety databases (e.g. Medra)
      • Flexibility to travel domestically and internationally
      • Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
      • Proficiency in basic computer applications
      • Fluent in spoken and written English
      • Excellent interpersonal, influencing and team building skills
      • Understanding guidelines (FDA, ICH, EMA and GCP)
      • Working knowledge of biostatistics, data management, and clinical operations procedures
      • Ability to act as a mentor/trainer to other staff Working Environment:
        PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
        
        Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
        
        Able to work upright and stationary for typical working hours.
        
        Ability to use and learn standard office equipment and technology with proficiency.
        
        Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
        
        May require travel. (Recruiter will provide more details.)
        
        PPD Defining Principles:
        - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing - We are one PPD -
        
        If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you
        
        
        Diversity Statement PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

Keywords: Pharmaceutical Product Development, LLC, Austin , PRINCIPAL INVESTIGATOR - ASSOCIATE MEDICAL DIRECTOR, Executive , Austin, Texas