The Sr.
Associate Medical Director is responsible
for all medical aspects of clinical development
including, but not limited to, protocol design; clinical trial implementation, management
and monitoring;
final study report preparation and review; preparation
for regulatory submissions; and interaction with regulatory authorities.
Planning
Determine clinical study design and assure
consistency with project goals
Review and approve operational budget
to include resource analysis
Review resource requirements across and projects
and inform management of issues which would
affect timelines and goals
Review and approve detailed operational project
plan including time and event schedule with
key milestones identified
Management
External:
Manage the medical/safety aspects of studies
performed by CROs or supported
by external resources
Monitor CRO performance
Establish and maintain relationships with
investigators and opinion leaders to optimize performance
on clinical activities
Internal:
Monitoring of Clinical Research Associates
performance (with Clinical Operations Manager)
Determine assignments of CRAs to represent the
medical function on interdisciplinary teams
Assurance that all medical monitoring functions
are consistent with GCP and the assurance of subject safety
Coordinating
Review, with biostatistics, plans for final data
presentations to assure accuracy and consistency
with protocol objectives
Write and/or review, and approve final clinical
trial report
Prepare results for internal and external
presentations
Represent Company at and other external meetings
Personal & Professional Development
Continually review and update role and
responsibilities
in light of changing business needs and seek opportunities to increase value to the
organization
Solicit feedback from managers and relevant others
about performance against objectives and seek opportunities for development
Create personal development plans in conjunction
with manager
As appropriate, provide mentoring to relevant
others
in areas of expertise
Requirements
MD degree
5 years clinical drug development experience
Demonstrated aptitude and knowledge in relevant
therapeutic field
Strong analytical skills
Proven effectiveness as team member
in clinical function
History of development of effective working
relationships
Ability to clearly discuss complex scientific
concepts and present data
Excellent oral and written communication skills
