PRINCIPAL INVESTIGATOR - ASSOCIATE MEDICAL DIRECTOR
Company: Pharmaceutical Product Development, LLC
Posted on: February 21, 2021
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
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.
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
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
Manages all medical aspects of contracted tasks across the
pharmaceutical product life-cycle.
- 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
- 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
- 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
- Provides medical review of adverse events of special interest,
serious adverse events and clinical outcomes events reported by
- 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
- 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
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
- Strong decision-making, problem solving, organizational skills
and analytical skills
- Excellent oral and written communication skills
- Working knowledge of relevant safety databases (e.g.
- 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
- 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
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
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology
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
Keywords: Pharmaceutical Product Development, LLC, Austin , PRINCIPAL INVESTIGATOR - ASSOCIATE MEDICAL DIRECTOR, Executive , Austin, Texas
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