In a customer facing/customer management capacity, the Executive Director will be responsible for building and maintaining positive client relationships. He/she will oversee all business aspects of clinical operations, project management/portfolio management, and business development accountabilities for the Oncology therapeutic area to achieve target revenue and profitability. Ensuring the contracted services and expectations of all projects are carried out by the project teams in accordance with executed contracts and Customers' expectations.
Through a matrixed staff, the Executive Director will manage the utilization and realization of project revenue for the business unit (BU), analyze financial data and budgeting, assume the role of primary liaison with Customers, Vendors, Senior Management and Investigator sites as needed, and organize department hierarchy and processes to achieve targets.
- Provides oversight for all assigned BU projects to ensure study launch, conduct and closeout occurs according to the Customer's and company's contractual agreement.
- Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations.
- Forecast, prioritize and direct staff to achieve on-time quality sponsor deliverables, contractual project requirements, utilization goals and profitable results.
- Create and execute on RFPs; ability to negotiate with clients to ensure operational processes are maintained, and projects are completed within scope.
- Works with senior management and Business Development to set strategic direction for BU to better target types of projects across selected customer segments, makes recommendations, and drives strategy execution for successful business growth.
- Evaluates progress of BU projects and assigned staff to ensure the meeting of targets for utilization, realization, and timelines.
- Develops and maintains knowledge of current therapeutic/critical market environment and drug development trends as needed. Facilitates team training in accordance with protocol and/or project requirements.
The successful candidate will have demonstrated experience in the Oncology therapeutic area. He/she must be a skilled relationship developer, employ an entrepreneurial spirit, with a high sense of urgency, and passionately embody the company mission.
- Requires a BA/BS in the life sciences, nursing degree, or equivalent education or equivalent related experience.
- Extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company
- Must have spent some time actively managing clinical research projects across functional areas, and other relevant experience is advantageous
- Requires supervisory experience within a CRO
- Must have demonstrated proficiency with ICH/GCP guidelines
- Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment is essential
- Requires strong presentation, documentation and interpersonal skills as well as a team-oriented approach
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail
- Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures
- Ability to travel 50%; domestic and international
- Demonstrated experience leading and managing complex programs on time, on budget, and with quality assurance and regulatory compliance
- Proven ability to think strategically and successfully operationalize ideas
- Experience working with cross functional medical and clinical teams
- Ability to work independently
- Strong communication skills (verbal and written) to express complex ideas
- Ability to manage multiple priorities within various clinical trials
- Proven experience and success working in a customer facing role