Director, Clinical Affairs- MEDICAL DEVICE

About Synthes

At Synthes, over 7,000 employees globally are focused on improving patient care and the medical industry as a whole. This focus has allowed us to continue achieving success as the producer of high quality orthopaedic instruments, implants and osteoobiologic products. If you share our focus, consider joining our dynamic and creative product development team at our corporate headquarters, located in West Chester, PA. In this role you will work closely with Product Development Engineers, Product Managers, Manufacturing, Sales Reps and Surgeons. Get involved and attend cadaver labs and surgeries. Be a key member involved in the hands-on design and development of new implants and instrumentation from concept through product launch. This includes understanding clinical issues, communicating with sales consultants and surgeons, and ensuring a quality product to the customer. We offer a business casual/team oriented atmosphere, competitive salary, yearly bonus and excellent benefits including: 401K with match, Tuition, Relocation and Flex Time. Synthes is also an Equal Opportunity Employer.

RESPONSIBILITIES:

Provide leadership and direction to Spine Clinical Affairs group. Direct the preparation of various clinical protocols and investigational plans, develop general and specific clinical strategies for the success of new products and be responsible for developing and administering the Clinical Affairs budget. Oversee a staff of about 15 with 3 direct reports.



•Direct the clinical research efforts required to support regulatory approval of new and modified products

•Develop, prepare and administer the Clinical Affairs budget

•Develop clinical strategies for new 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.

•BS/BA 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 regulations

•Knowledge 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

At Synthes, we focus on improving patient care and the medical industry as a whole. This focus has allowed us to continue achieving success as the producer of high quality orthopedic instruments and implants. If you share our focus, consider joining us.

We offer a competitive salary and excellent benefits, and we are an Equal Opportunity/Affirmative Action Employer. If you are interested in exploring career opportunities with us, please click on one of the links below for more information!
REQUIREMENTS
Please see above.