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VP Clinical Affairs

Durham, NC | Clinical Affiars

Job Description

 

General Summary

Health Decisions leads in technology-based agile and adaptive trials – both design and operations including adaptive and risk-based monitoring and other agile trial methodologies.  The preferred candidate for this role does not need to have experience in agile or adaptive but must be open to and professionally committed and aligned with needs of an innovative company in the field of clinical trials.  The ideal candidate will understand that the industry can and needs to change and will be excited about joining a team committed to leading that change.

 

This position will be responsible for overseeing all aspects of Clinical Affairs, Biometrics, and Data Management within the organization, cross functionally to include project management and clinical monitoring. 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.  This position will also provide oversight of medical monitoring and safety/pharmacovigilance functionality. He/she will report directly to the Chief Operating Officer of the organization and is focused on several operational areas including, but not limited to workforce planning, process improvement, training, staff development, retention & hiring, new client acquisition support, partnership with Business Development, client relationship building, delivery of high quality projects, P&L management and Clinical Affairs strategic leadership.  The selected individual will be a member of the Management Leadership team and will be expected to work with other leaders within the organization for collaborative direction and decision-making.  This role will have several direct reports, including Directors, managers, and individual contributors.

 

Responsibilities

While the following responsibilities accurately describe the role, the individual we are seeking is expected to also bring strong leadership qualities must be a thoughtful, imaginative, flexible, tech-savvy person who is motivated by our vision of the future and capable of the following:

  • Provide strong leadership to Clinical Operations, Biometrics, and Data Management departments
  • Be prepared to provide effective, credible, senior-level support when asked to support the business development effort with potential client organizations
  • Partner with Business Development to support lead development and sales efforts
  • Provide knowledgeable input on company position on scientific and medical content.
  • Provide guidance to innovate to achieve productivity targets, clinical trial strategy and design; product labeling and approval of promotional materials in compliance with corporate standards, domestic and global government/industry regulations (with the assistance of regulatory affairs).
  • Provide guidance and contribute effectively to development and scalability of global trials
  • Interface directly with clients and prospective clients, ensuring quality and expectations are met
  • Serve as a member of Leadership Team, participating in operations strategic leadership meetings
  • Provide guidance and direction for all aspects of Clinical Affairs, Biometrics, and Data Management with a focus on continuous process improvement and global scalability
  • Coordinate effectively and collaboratively with other departmental leaders and senior management to solve problems and take advantage of opportunities
  • Analyze, plan and strategize the formation of clinical program goals, as well as practice operations and activities.
  • 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
  • Oversee departmental budget and participate in budget reviews and revisions per the needs of the business
  • Establish clear direction for managing staff development and training with a focus on productivity, accountability, staff retention, travel and expense, billability
  • Provide overall direction, guidance, and coordination for global clinical policies, procedures and programs
  • Maintain ISO compliance status
  • Direct and guide the development of effective supporting departmental policies and procedures
  • Provide the direction and guidance required for effectively managing and coordinating global performance management and quality improvement programs using a data-driven focus, setting priorities for improvement(s) aligned to ongoing strategic imperatives and scalability
  • Serve as the senior level mentor for Directors, Managers, and staff both internally and externally.
  • Provide guidance, direction, and participate in the planning and management of investigator meetings, advisory boards and other scientific committees.
  • Foster an environment of teamwork and productivity and scalability, results, communication, creativity
  • Actively participate in the design and development of staff development to include training, performance reviews mentoring and recruiting
  • Travel as needed

 

Accountability Measures

  • Operation achieves its stated objectives and the VP CA is credited for the Clinical, Biometrics, and Data Management contributions with a very good to excellent performance review.
  • Performance reports show satisfactory levels of compliance, dependability, reliability, and financial performance.
  • Relationships with coordinates, interdepartmental partners, internal /external customers, and external agency personnel are harmonious and productive.
  • Periodic meetings among the leadership teams reveal no significant problems in the area of Clinical Affairs, Biometrics, or Data Management.
  • Executive team agrees that cross-functional relationships, procedures, processes, and data/information flow pertaining to billable departments under VP’s direction  are effective.

 

Skills, Knowledge and Ability:

  • Apply experience, competence, and industry / global clinical trials knowledge to planning, management, and growth of the Clinical Affairs, Biometrics, and Data Management departments.
  • Apply experience, competence, and industry knowledge to improvement activities within Clinical Affairs, Biometrics, and Data Management departments.
  • Demonstrated experience interacting effectively with senior client leadership in client sales situations
  • Maintain a fluid knowledge of Good Clinical Practices (GCP), ICH Guidelines and FDA Regulations
  • Maintain and expand strong Global and Regulatory experience and knowledge
  • Possess and develop exceptional negotiation, problem-solving and leadership skills
  • Demonstrated experience managing client relationships
  • Understands or capable of learning adaptive and agile approach to clinical trial development
  • Understand and create process improvement plans utilizing industry experience and process measurement data.
  • Influence, persuade, and engage others to adopt appropriate practices, procedures, and processes to provide a concept that differs from the industry norm.
  • Work cross departmentally to resolve issues and develop lasting effective relationships and solutions.
  • Build a culture of discipline and accountability- develop disciplined people who engage in disciplined thought and who then take disciplined action.
  • Ability and knowledge of planning and managing improvement projects.
  • Strong project management plans which will lead to satisfied sponsors and increased and repeat business.
  • Knowledge of operational and financial analysis, workload and resource forecasting, and performance data analysis to identify and address performance obstacles and opportunities
  • Ability to effectively delegate duties.
  • Strong and effective coaching, training, management development, and succession planning.
  • Ability to create and present information in ways that effectively inform, persuade, and engage others.
  • Ability to plan and conduct meetings that achieve specific goals/outcomes while engaging participants to get their best ideas.
  • Ability to create, and present plans and bid defense presentations that are intelligent, focused, persuasive.
  • Ability to confront conflict in ways that lead to effective and sustained resolution.
  • Apply a high level of conceptual/abstract thinking to planning, organizing, and managing the Billable depts.
  • Manage resources and budgets to meet financial objectives.
  • Raise professional management standards within the Clinical Affairs, Biometrics, and Data Management departments.
  • Recruit, train, develop, and retain talented people.
  • Implement and manage change as required.
  • Create a positive work environment, engage people, and inspire esprit de corps.
  • Provide leadership, getting the best out of people.
  • Ability to manage with creativity, flexibility, respect and professionalism. 

 

Key Characteristics / Traits:

  • Confident without being arrogant
  • Strong, confident, persuasive presence with senior management and corporate level leaders
  • Speaks, presents, and communicates effectively
  • Decisive; and shows good judgment
  • Anticipates and handles problems before they become major issues
  • Engages staff as a resource to solve problems & implement solutions through “rigorous” questioning, not answers
  • Engages staff in dialogue and debate, not coercion.
  • Resilient and can handle setbacks and pressure well
  • Shows initiative and anticipates problems and opportunities ahead of the crowd
  • Unafraid of conflict and maintains composure and resolves conflict professionally
  • Inspires confidence
  • Intellectually honest and discreet
  • Commands the respect of others
  • Strong (won’t wilt at first challenge)
  • Understands effective delegation, follow-up, flawless delivery process
  • Elicits trust
  • A willing and effective coach.  Others seek him/her out for advice and guidance

 

Education:

  • Undergraduate degree in business or health sciences from an accredited institution, or their international equivalents; or equivalent work experience.
  • Targeted coursework in business (management, marketing, accounting), budgets, personnel management, negotiation skills, etc. preferred.
  • Advanced degree (M.S. or M.B.A.) preferred

 

Experience:

  • Minimum of 12 years experience in Clinical Research industry (CRO or Pharma/Biotech environments)
  • Minimum of 10 years experience in Clinical Operations Management, as well as strong knowledge of Safety and Medical Monitoring areas preferred.
  • CRO operations experience
  • BD support experience helping to close large clinical trials.
  • Experience managing, supervising and/or directing global mid size teams
  • A successful track record and experience with process improvement.
  • Experience in positions requiring budget understanding and resource forecasting and management
  • Managing professional staff or comparable team management experience required
  • Extensive experience with Global clinical trials including managing overseas clinical staff and partners
  • 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

Other Job Requirements:

  • Must fulfill criminal background checks
  • Some travel is required –approximately 20%
  • When applicable, may be required to work nights and weekends
  • A strong understanding  of technology and an appreciation of the way it can be used in our industry is critical.

 

 

 

Health Decisions is an Affirmative Action/Equal Opportunity Employer. All qualified candidates are encouraged to apply. 

Veterans are encouraged to apply.

Health Decisions is an E-Verify employer. E-Verify is an Internet based system operated by the D,partment of Homeland Security (DHS) in partnership with the Social Security Administration (SSA) that allows participating employers to electronically verify the employment eligibility of their newly hired employees in the United States. Please click on the following links for more information. E-Verify Participation Poster: For English click here, For Spanish click here E-Verity Right to Work Poster: For English click here, For Spanish click here

 

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