Medical Director - Internal Medicine/Respiratory/Rare Diseases - Americas
Company: Worldwide Clinical Trials - USA
Location: Austin
Posted on: March 17, 2023
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Job Description:
Who we are We're a global, midsize CRO that pushes boundaries,
innovates and invents because the path to a cure for the world's
most persistent diseases is not paved by those who play it safe. It
is built by those who take pioneering, creative approaches and
implement them with quality and excellence. We are Worldwide
Clinical Trials, and we are a global team of almost 3,000 experts,
bright thinkers, dreamers and doers and, together, we are changing
the way the world experiences CROs - in the best possible way. Our
mission is to work with passion and purpose every day to improve
lives and we are looking for others who value this same pursuit.
What Medical Affairs does at Worldwide Medical Affairs impacts
every stage in the lifecycle of a clinical investigation. From
Business Development to Regulatory Submissions, members of the MA
team support the larger project team, and help establish the
medical orientation that characterizes the philosophy here at
Worldwide. Activities include direct interactions and presentations
with medical and operational personnel from pharmaceutical
companies in the process of business development; protocol
preparation and country specific feasibility assessments for
proposed investigations that inform study design and operational
metrics; training of investigative site staff and members of
Worldwide project teams on medical or assessment methodology unique
to a given study, and the medical monitoring of adherence to
enrollment criteria for study candidates as well as medical
management activities for patients during the course of the trial.
A pharmacovigilance activity for adverse event analyses and
reporting is an integral part of the service offering. Medical
Affairs also partner with other functional groups within the
Worldwide organization for the design and execution of "first in
man" studies (CEDRA), the generation of statistical and clinical
reports at study conclusion, and scientific/medical assistance in
the preparation of regulatory submissions such as investigative new
drug applications which permit the initiation of clinical testing.
What you will do Medically manage clinical trials to which s/he is
assigned as Medical Monitor, serve as Global Lead Medical Monitor
(GLMM) for pan-regional and/or global trial(s) to which s/he is
assigned; provide after hours medical support for projects to which
s/he is assigned Provide therapeutic and protocol-specific training
to the project teams; contribute medical input into the design of
clinical development programs, study protocols, research papers,
client focused white papers, etc.; as directed support Business
Development through participation in proposal generation,
feasibility assessments, review of proposals/contracts for medical
services, and attendance at meetings with sponsors as directed by
department senior management; assist in the annual attainment of
departmental revenue targets and any other activities as directed
by senior management; assist in the mentoring of other medical
staff) as directed by Senior management and by consistently
displaying exemplary work ethics, compassion and integrity,
supports Senior Management's leadership of both the department and
the company Collaborate with the other members of the Medical &
Safety project teams to process Serious Adverse Events (SAEs);
demonstrate competence with the execution of SAE related medical
review in WORLDWIDEs electronic safety database Review and/or
assist in the preparation of final study reports (CSRs), or other
study documentation (Protocols, ISS/ISEs etc.,) as directed by
senior management; maintain a high level of competence with
assigned projects, including knowledge of project and therapeutic
advances as well as marketplace developments by participating in
internal meetings (company-wide project tracking, medical
management meeting, etc), review of relevant therapeutic/clinical
literature and attendance in conferences and meetings; interact
with staff in other functional areas within the company to ensure
the highest level of client satisfaction through successful
execution of projects; identify, document and appropriately resolve
out-of-scope work as directed by senior management What you will
bring to the role Strong supervision, interpersonal and
communication skills as well as conflict resolution skills and be
committed to quality and honesty Must possess exceptional
organizational and planning skills and good documentation skills.
Must be punctual and have a flexible work schedule. In-depth
knowledge of the clinical research process, including Good Clinical
Practices. Working knowledge of GCPs and regulatory requirements
relating to clinical development and safety assure compliance with
ethical, legal and regulatory standards. Clinical/therapeutic
acumen in medical subspecialty through online and/or in person
scholarly programs/lectures Able to make good, sound decisions
under stress and time constraints. Your background A Medical degree
(M.D.) with a specialization (board certification) in Internal
Medicine or similar field At least 2 years of medical monitoring in
clinical research or related industry Why Worldwide At Worldwide,
we balance fun with the serious business of changing lives. We have
a values-driven culture that is built from the ground up. We
empower our team members to treat every clinical trial like a
patient's life depends on it - because it does. Our leaders are in
the trenches with you - committed to advancing science and moving
mountains for our customers. Interested in hearing more about
Worldwide or our roles? Check out our careers page at !
Keywords: Worldwide Clinical Trials - USA, Austin , Medical Director - Internal Medicine/Respiratory/Rare Diseases - Americas, Executive , Austin, Texas
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