Director of Clinical Affairs - Medical Device

SECURE YOUR FUTURE! Our client company is a MAJOR MEDICAL DEVICE company looking for exceptional candidates to be a part of their successful, very stable and explosive growth organization! Great benefits and relocation package.
Reports to the Vice President, Regulatory and Clinical Affairs.Provides leadership and direction to Clinical Affairs group.Directs the preparation of various clinical protocols, investigational plans, etc.Develops general and specific clinical strategies for the success of new products.Responsible for developing and administering the Clinical Affairs budget.Direct the clinical research efforts required to support regulatory approval of new and modified products.Develop and administer clinical education programs.Provide clinical consultation to senior management regarding clinical issues related to new products.Provide support and assistance, as required, to the Vice President, Regulatory & Clinical Affairs.Responsible for mentoring and developing the professional skills of Clinical Affairs employees.Assess resource needs and allocate departmental resources to assure accomplishment of corporate goals for new product approvals.Foster credibility of the Clinical Affairs groups with stakeholders such as FDA, Product Development, Manufacturing, etc. REQUIREMENTSBA/BS Degree required; Advanced degree preferred.10+ yeas of prior experience in clinical trials.5+ years of management experience in medical device clinical affairs.5+ years of experience in the Medical Device Industry.Specific experience with Class III medical devices.Expert understanding of medical device regulationsKnowledge of statistical concepts as they apply to clinical trials.Management experience with CRO's.Expert understanding of clinical trial methodology, including GCPs.Excellent oral and written communication skills.Well developed interpersonal skills.Strong advocacy background.Experience in senior level negotiations.Strong business aptitude and acumen. TO BE CONSIDERED, PLEASE E-MAIL YOUR RESUME IN WORD DOC FORMAT.