Description:
General Summary:
This key position within the Clinical function is responsible for providing medical and scientific expertise to bring high quality and efficiency to the clinical trial development process for devices in the product pipeline. This position is also responsible for contributing to overall safety surveillance activities. This leader may be responsible for the supervision and management of other safety professionals.


Duties and Responsibilities:
Maintains timelines by providing high level medical/therapeutic guidance to internal and external customers including project teams, functional units, investigators, and regulatory agencies.
Provides early, hands-on operational support to teams in clinical trial planning, protocol development, training of internal and external personnel, medical monitoring for trial safety, and quality control.
Assists in implementation of worldwide practices, policies, and processes for the medical and clinical affairs function of the various platforms.
Provides therapeutic area expertise to support development and execution of clinical trials in device development process.
Reviews and edits protocols to insure accuracy, consistency with standard of care, logistical ease, and internal consistency at BSC.
Reviews, edits and approves adverse event narratives to ensure that written summaries are medically accurate.
Develops policies for interaction with independent study committees; ensures exchange of information with these committees is adequate to meet study timelines.
Provides direct physician support to quality assurance group for review of product complaints, MDR reporting criteria, health risk assessments, and product performance criteria.
Writes and edits clinical reports for regulatory submission and updates to insure medical accuracy.
Provides medical monitoring to insure patient safety and adequate reporting and coding of adverse events in clinical trials.
Participates in review of pre-market and post-market aggregate safety data to promote early detection of safety trends and signals.
Supervises other less experienced safety personnel and provide the appropriate guidance, coaching and development.
May independently or with the Chief Safety Officer to develop new strategies and procedures for meeting evolving challenges and expanding deliverables.
Collaborates with Chief Safety Officer in the development of functional infrastructure including creation of policies, procedures, as well as the drafting and/or reviewing of SOPs and Work Instructions.

Minimum Education & Experience:
Medical degree required with board certification preferred in area of therapeutic expertise. 5+ years of clinical experience with patient care. A minimum of 5-7 years of clinical trial experience is desired. Some direct industry experience (device, pharmaceutical, and biotechnology) is required. In addition, at least 3 years of previous experience managing and supervising staff is preferable.

Working Conditions:
General office environment, and includes approximately 40% to travel to research laboratories, meetings, and/or other BSC facilities. There is potential for exposure to blood borne pathogens and other potentially infectious materials.

Competency Expectations:
Evidence of a management style characterized by leadership, vision, collegiality, teamwork, preparation and communication.
Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of global clinical studies, as well as preparation of clinical documentation in support of regulatory submissions.
Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.
Experience in writing scientific reports.
Strong organizational and interpersonal skills, including the ability to teach, motivate and coach others.
A self-confident, analytic, intelligent, strategic thinker with the highest personal integrity.