$200K — $250K *
GI Dynamics is seeking a Director of Clinical Affairs to manage various aspects of the clinical department
for assigned project(s). This includes contributing to the strategic and operational leadership relative to
the direction, planning, execution, and interpretation of all programs and the data collection activities. As
a management team member, works to establish and approve methods for design and implementation of
clinical, projects, including protocols, data collection systems and final reports, clinical activities.
Responsible for selection, management of vendors in support of department. Contribute to meeting
clinical budget. Also has operational responsibility for training, labelling, package design, etc. related to
US and OUS clinical trials. Monitors adherence to protocols requirements. Interacts with various
inside/outside groups to facilitate all programs. May select, develop, and evaluate personnel to ensure the
efficient operation of the function. This job contributes to and supports the company's research and
development, efforts to create high value medical devices to address unmet clinical needs.
Develops global clinical affairs strategies, in collaboration with management, regulatory affairs,
marketing, research & development, reimbursement and outcomes planning, and obtain approvals
by the most effective method possible.
Develop and execute Clinical Affairs Strategy to generate data for both regulatory and marketing
Travels to clinical sites for training and clinical trials oversite
Enroll and manage KOL / physician-clinician engagement and lead the management of all Clinical
Affairs investments and required support
Execute studies in the US, and OUS in full compliance with all applicable GCP requirements, and
local and international regulations and standards.
Negotiates contracts and budgets with sites, CRO's and vendors.
Responsible for data collection, analysis, and presentation to company management
Responsible for preparing data for publication, white papers, presentations, etc.
Manages team to prepare protocols for projects; reviews final study conduct documents such as
study manuals, study plans, study tools, etc.
Develops staffing plans according to needs.
320 Congress Street, 3rd Floor • Boston, Massachusetts • 02210
Initiate investigator and coordinator meetings.
Participate in Risk management and R&D DRs representing clinical affairs
Provides oversight of individual clinical trials to ensure full compliance with GCP and that safety
concerns and/or adverse events are identified and appropriate responses to such concerns are
Provides advice to the customer complaint reportability team of adverse events and other clinical
trial issues to regulatory agencies.
Determines membership criteria and identifies potential members for clinical events committees and
data monitoring committees. Reviews and approves trigger plans for CEC and DMC.
Reviews and approves Clinical Risk Benefit Analyses.
Reviews and approves study corrective action plans. Prepares for and participates in
internal/external study-related audits.
Develops and maintains Clinical Investigation, conduct infrastructure – drafting and/or reviewing of
SOPs, DOPs, and Work Instructions.
Demonstrates thorough knowledge of and coaches’ others in the appropriate application of clinical
research conduct, laws, regulations, standards, and compliance with applicable SOPs and policies
Bachelor’s degree in related field and 15+ years’ clinical experience, preferably in medical device
Master’s degree (MBA, MSN, MS) or Doctorate highly desirable
Extensive knowledge of FDA requirements, hospital, and health care environments
5+ years’ experience in direct management of clinical teams required
Excellent written and verbal communication skills required
Experience interacting with physicians, clinicians, and patients
Possesses excellent leadership skills and ability to be very flexible, adaptable, and to work under
Self-motivated and self-directed; conscientious approach to work assignments; enjoys the
challenges of multitasking and working at a fast pace while staying flexible to shift tasks
Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities; and
ability to maintain good working relationships while dealing appropriately with sensitive and
confidential matters and with a wide variety of personal and telephone contacts
Demonstrated record of success and leadership
Valid through: 9/24/2020