Our client, a successful medical device/pharmaceutical company, has an opening for a Clinical Affairs Manager.
Within the last two years, this company has acquired over 9 new technologies/companies and is expecting 8 new product releases in the next year! Poised for further growth, you will enjoy opportunity for advancement, great benefits, exciting and innovative culture and the opportunity to make a positive impact.
The Clinical Affairs manager will be responsible for the full management of high quality clinical research programs to support timely approval of products. The Clinical Affairs Manager will perform direct/indirect management of Clinical Research staff, serve as a clinical study project leader, prepares clinical reports and assists in data analysis, set clinical trial milestones and timelines, oversees and participates in global clinical program activities including but not limited to: FDA strategy meetings, Regulatory submission preparation, and review (IDE, 510k, PMA, CE Mark) and lead overall direction of Contract Research Organizations (CRO) when needed. The Clinical Affairs manager will also be responsible for monitoring of expenses against the departmental budget, create and implement departmental policies and procedures and provides technical or clinical feedback to the R&D staff.
Requirements for this position include:
Minimum of a Bachelors degree (Masters degree preferred) in Life Science (Animal Science, Biology, Physiology, Nursing, Medical Technology) plus a minimum of five (5) years experience in medical device/pharmaceutical drug customer relations or clinical research and a minimum of two (2) years experience managing a professional staff.
Successful candidates will have examples of:
Administering successful programs within a timeline
Ability to hire quality professionals and develop direct reports
Demonstrated leadership to develop, motivate and guide subordinates to meet objectives in a timely fashion. Work related clinical trial experience.
Strong leadership, project management and organizational skills.
Good working knowledge of Regulatory Affairs (FDA/CFR; EN540/GCP)
Willing to Travel Approximately 20 - 40%
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