Director, Clinical Operations / Affairs – Medical Device

General Description:   The Director of Clinical /Operations Affairs is responsible for the management and oversight of all clinical studies from the strategic planning phase through the conduct of the trials. This position will be involved with planning, implementing, and monitoring high-dollar budgets.  This position will have a direct impact on successfully planning and executing clinical trials in a timely manner.  This position manages Clinical Research Associates, other clinical support staff, investigational sites, consultants, and vendors.



Job Responsibilities:
Manages planning, design, and conduct of clinical studies in support of FDA Premarket Approval (PMA?s), 510(k) submissions, post-market studies, internal studies, and feasibility studies, as required.  Specific clinical duties include writing protocols, monitoring, and auditing clinical sites, developing support documentation for product submissions, and conducting appropriate training including Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). Interface with all principal investigators and their staff.
Participate in the negotiations of clinical trial protocols and submissions with the FDA: including managing the clinical component of the FDA meetings and preparing relevant materials, documents, and presentations.
Provides input on large clinical projects to determine work needs, resources, and division of both internal and external resources (CROs).  Builds a resource file of appropriate investigation sites, provides monitoring strategies, and participates in developing new clinical trial sites.
Prepare strategic project plans, including budgeting for Clinical Operations & Affairs department and prepare individual department and corporate goals, monitor progress against plan, and provide periodic reports to management on performance. Develop and defend internal staffing needs, building an effective team to support departmental goals.
Develop policies and procedures that provide direction to the Company on clinical trials in support of the Product Development Process (PDP).
Maintain proactive and positive working relationship with internal and external customers to assure clinical studies position the Company to meet strategic corporate goals.
Continually strive to maintain positive relationships with clinical investigation sites, advisory boards, and any other contracted clinical institution, promoting Company?s product approval strategy.
Provide input to external research trial design regarding compliance and site management for products that ultimately are commercialized in PMA, 510(k), and ASR reagents formats.
Assist in protocol design and training, as well as providing strategic assistance to marketing.
Minor travel involved (approximately 10%)



Job Requirements:
Must have 7-10 years experience in a significant clinical operations and affairs management role in the medical device industry. 
Some experience in regulatory and clinical affairs for medical manufacturing. 
Management experience required. 
Must have successfully completed clinical trials that resulted in the approval of PMA and 510(k) products for the clinical oncology market.

? Working knowledge of the clinical development needs for medical device pre-market approval (PMA) process, 510(k) process and ASR guidelines in the Oncology field. Good Clinical and Good Laboratory Practices (GCP/GLP?s) required. 

? In Vitro Diagnostic product experience and experience with complex, software driven medical devices are desirable.

? Supervisory Ability: The incumbent will supervise a team of CRAs, data analysts, and other clinical support staff.  Must have the ability to make decisions, act upon them with little or no direction, and accept accountability for outcome of decisions.  Must have a commitment to setting department goals and objectives, both short and long term.  Must have demonstrated experience as an effective manager for a clinical trials team.

? Must possess excellent oral and written communication skills and have the ability to relate well to others. 

? Must represent the company in a professional manner to outside entities. 

? Must have the ability to see individual department(s) within the context of the entire company; ability to evaluate, isolate, and appraise situations to determine best course of action; ability to maintain confidential information at appropriate levels within the organization; have the desire to constantly improve their skills and for those who work for them.

? Education: Minimum of a Bachelors degree (scientific discipline preferred)



Company Information:

Our client is a medical device company currently experiencing significant growth.  The atmosphere is very exciting, well supported by the R&D team, working on cutting edge molecular markers for cancer diagnosis and screening.  They currently have 7 products in development and anticipate at least 1-2 major trials coming up every year for the next few years.



Location: Durham, NC



Compensation: 120-135K (commensurate with experience), 25% Bonus, Equity

 

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