VP of Clinical Affairs 8/8/2016
JOB DESCRIPTIONAPPLY Seeking a skilled and experienced leader in the field of Clinical Operations, Contract Research Organization, Clinical Trials Management, or Pharmaceuticals/Biotechnology to fill a Vice President role! This is a full-time opportunity with one of our clients in Durham, NC. Target salary range is $175,000-$200,000 plus bonus potential. Local candidates strongly preferred, although relocation assistance may be available on a case-by-case basis. No sponsorship or C2C arrangements available. This position includes up to 30% travel.
The Vice President of Clinical Affairs must provide strategic leadership and executive oversight to all operational functions. This position will be responsible for overseeing all aspects of Clinical Operations, Biometrics, and Data Management within the organization and have accountability for the delivery of all projects across the company's portfolio of clients. In addition, the incumbent will support the sales and marketing efforts of the company and must have the capability and credibility to effectively interact with senior decision makers at potential and existing client organizations.
RESPONSIBILITIES OF THE VP OF CLINICAL AFFAIRS:
* Establish and implement the overall vision, objectives and strategy for the company's Clinical Affairs department
* Provide executive oversight to the company portfolio of studies through the management of internal staff, third party vendors and interaction with executive-level staff
* Provide executive account management activities for select company clients
* Provide clinical leadership to all business development activities
* Strengthening the key talent pool across Clinical Affairs
* Provide strategic leadership to support the evaluation and implementation of a new clinical operating platform ( CTMS/eDC/eTMF) that will drive operational excellence and deliver significant operational efficiencies
* Represent Clinical Affairs on the company executive committee and provide clinical leadership to enable successful delivery against the companies 3 year strategic plan
* Lead a group of 4 directors to ensure high quality clinical service delivery and outstanding performance across all accountable business functions
* Support the development of new business ventures and alliance partnerships to enhance company service capabilities
* Manage and oversee financial and budgetary aspects of the Clinical Affairs department
* Maintain on-going awareness of developments with the clinical research field
* Interact with business development in presenting the company and capabilities, review and decide on potential business opportunities, review and approve proposals
* Provide senior clinical review of client proposals, participate at client bid defense meetings and/or perform client presentations as requested
* Interact with clients, as required, to ensure quality and expectations are met, and provide a complete understanding of the company's project management, clinical monitoring, biometrics and data management responsibilities
* Provide guidance and contribute effectively to development and scalability of regional and global clinical trial operations
* Chair the Clinical Affairs Leadership Team
* Coordinate effectively and collaboratively with other departmental leaders and senior management to solve problems and take advantage to strengthen company service capabilities or market share
* Ensure that staff is properly allocated with appropriate resources in order to achieve project deliverables and expectations of clients, while maintaining appropriate revenue goals and margins
* Serve as a senior level mentor for Directors, Managers, and staff both internally and externally.
* Foster an environment of teamwork, productivity, results, communication, and creativity
* Actively participate in the design and development of staff development to include training, performance reviews mentoring and recruiting
EXPERIENCE AND REQUIREMENTS OF THE VP OF CLINICAL AFFAIRS:
* PhD in a health-related discipline. An equivalent combination of degree plus experience will also be considered.
* Minimum of 15 years' experience with Clinical Trials management, CRO or Pharma/Biotech environments required. CRO operations experience preferred
* Minimum of 7-10 years' experience in Clinical Operations leadership roles, as well as strong knowledge of Safety and Medical Monitoring areas preferred
* Direct experience creating and implementing the strategic direction of a company or business unit
* Experience managing, supervising and/or directing a team of 30 people
* A successful track record and experience with process improvement
* Experience in positions requiring budget understanding and resource forecasting and management
* Thorough knowledge of Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research
* Managing professional staff or comparable team management experience required
* Experience with interacting with the FDA and supporting FDA inspections from a clinical perspective
* Diverse therapeutic background experience managing, mentoring, motivating and inspiring direct reports toward our company's vision for the future
* Track record of managing several projects/programs simultaneously
* Excellent interpersonal, verbal and written communication skills
* Experience making presentations and hosting meetings
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