Director of Clinical Affairs- Chronic Pain

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Location
Plano, TX
Salary
$180,000 - $250,000
Job Type
Direct Hire
Date
Jan 10, 2018
Job ID
2557756
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The Clinical Research Director will provide leadership and strategic direction to the clinical/data management departments. Responsible to understand the business strategic plan and provide direction so that the clinical research department is proactively addressing the CVD strategic plan. Accountable for the development of staff through critiques, instruction, mentoring, evaluation, and coaching.  Models optimum leadership competencies to inspire an energized, empowered, and accountable work force, and ethical behavior. Ensures that clinical studies are designed, implemented and maintained so that the rights of the subjects are protected and that internal and external personnel involved in each study are trained and compliant to regulations. Ensures that the clinical research department is aligned with the business objectives.
Responsibilities:
  • Provides strong clinical/scientific support to clinical projects.
  • Leverages appropriate internal and external expertise to successfully execute on clinical studies.
  • Continually identifies and promotes strategies for improved clinical research quality and best practices across the clinical research department. Proactively assesses clinical project progression for early identification of issues or trends and develop strategic responses.
  • Provides leadership to clinical research department in alignment with company strategic goals.
  • Manages personnel resources to appropriately support clinical initiatives.
  • Provides clear on-going guidance and support to direct reports and department regarding clinical research priorities.
  • Identifies and creates career growth opportunities for direct reports
  • Ensures adequate resources are available and that these resources have the required experience, education and training to successfully perform their job responsibilities.
  • Ensures the department is knowledgeable in current domestic and international clinical regulations.
  • Provides direction for clinical research budget and run department in accordance to budget.
  • Ensures appropriate project/program management occurs in each project to ensure time lines are met.
  • Provides direction for the interpretation of clinical results and preparation of study summaries for regulatory submission, presentations and publications as necessary (including all data cleansing, data management and statistical analysis activities).
  • Provides strategic input and direction to organization for publications, presentations, investigator meetings and other public forums in which Cardiovascular clinical data is presented or interpreted.
  • Identifies and accesses clinical research key opinion leaders to assess support for new research concepts and strategies.
  • Interfaces with regulatory authorities directly as appropriate (e.g. FDA panel meetings, BIMO audits, etc). Supports all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Qualifications:
  • Bachelor's degree and 10+ years of related work experience or an equivalent combination of education and work experience.
  • MS degree or PhD preferred
  • 10+ years in clinical research within the medical device industry
  • Minimum 10 years’ experience with direct personnel management
  • A solid knowledge of clinical biostatistics and applicable clinical trial regulations both US and OUS
  • Demonstrated leadership/management skills with respect to achievement of company goals and objectives
  • Must possess strong oral and written communication skills
  • Must be adept at working across cross-functional teams
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results 
  • Ability to work effectively within a team in a fast-paced changing environment
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Multi-tasks, prioritizes and meets deadlines in timely manner
 
 
Preferred Experience:
  • Active Implantable Medical Devices experience preferred
  • Preferred experience in cardiovascular / neuroscience therapeutic area for both pre-market and post-market approval clinical trials
  • Experience working in a broader enterprise/cross division business unit model preferred
 
Identifier: $medd