Director Clinical Affairs

Scientific Skillsets:
* Establish clinical strategies for product approvals and expanded indications
* Is able to design clinical trials. This requires effective interaction and communication with statisticians, medical advisors and other scientific disciplines (e.g. pharmacologists)
* Must understand statistical concepts, implications of statistical assumptions on study design, sample sizes, outcomes
* Can develop a range of clinical strategy options for senior management to consider, makes recommendations, facilitates decision making
* Develops clinical endpoints: considers range of alternatives, reviews literature, consults with advisors, to select appropriate clinical study endpoints
* Can write exceptionally well; can write justifications, papers, clinical protocols, reports; has a keen eye for technical writing
* Data-driven: Is adept at analyzing data; makes decisions and recommendations based on data; can drive completion of a statistical analysis plan
* Develops strong ties with clinicians and though leaders - develops reputation in the industry for credibility, good clinical science
* Establish and implement plans for publication of relevant scientific data in appropriate journals

Clinical Operations:
* Experience conducting both device and drug studies is preferred
* Directs clinical operations, including, establishing timelines, site selection, patient recruitment, processing of data, analyses and completion of clinical trial report(s) to support product approvals and compliance with international regulations.
* Develop annual and study-specific operating budgets for Clinical Affairs to meet long-term company and departmental objectives; creates detailed study budgets and communicates closely with Finance on study budgets and changes in scope
* Capable of evaluating, selecting and managing Contract Research Organizations (CRO) to supplement the department. Creation of RFP, solicitation of bids, evaluation of all aspects of services from site management/monitoring to data management, biostatistics and report writing.
* Is familiar with conducting trials using paper CRFs and electronic data capture (EDC): capable of evaluating EDC platforms to select appropriate platform for company's studies
* Establishes aggressive timelines and plans proactively to complete clinical studies on time.

* Has experience organizing and leading investigator meetings
* Is willing to travel up to 50% of time. Personal travel to investigational centers is critical to study success: establishing rapport with investigators, reinforcing importance of timely, high quality data, overseeing monitors as needed, troubleshooting, case coverage.
* Travel also includes attending major meetings, meeting with clinicians on study designs, analysis, authoring of papers.

EDUCATION REQUIREMENTS: Minimum of a Bachelor of Science degree in the Life Sciences/Engineering, or equivalent job experience. Advanced degree preferred.

EXPERIENCE REQUIREMENTS: A minimum 10 years' experience in the medical device industry, including at least 10 years of direct experience in clinical/regulatory affairs for medical devices and a minimum of 10 years supervisory experience.
Seeking candidate who has seen a clinical development program through from pilot study through pivotal studies, including FDA interactions, and FDA filing / approval (e.g. written Summary of Safety and Effectiveness Data).

To find out more about Real Staffing please visit www.realstaffing.com