FHI 360 has a long history support clinical research. Our Global Research Services (GRS) operating unit has become an independent, commercial organization named FHI Clinical Inc. FHI Clinical helps support and conduct clinical research in low-resource settings around the world. Our team includes clinical project managers, clinical research associates, research assistants, laboratory technologists, laboratory auditors, document specialists and instructional designers.
With culturally sensitive and multilingual employees in the United States, Africa, Asia, Latin America and Europe, FHI Clinical offers the following services to government and private sponsors:
- Protection of participants’ safety and rights
- Site identification, evaluation and development
- Site monitoring, management and training
- Research operations
- Laboratory capacity building, auditing, and training
The Sr. Clinical Strategy Director will provide leadership and support in building out the Global Strategy function, playing close attention to the cross-functional nature of the role and the need to collaborate across the Company and around the world. This position will lead the establishment of a study-feasibility function and define FHI Clinical’s approach to alliance management and strategic projects. While providing oversight of the business insights function, this position will be a key partner both internally and with sponsors, collaborating with the business development team.
Listing of the material responsibilities and essential duties of the role,
- Provides strategic leadership and oversight during the build-out of the Strategy function.
- Identify the need for and operationalize systems and tools to operationalize the new function
- Support the development of an investigator relationship function, including the process and tools by which we capture and codify the relationships
- Working closely with VP of Strategy, build a site sustainability strategy and operationalize it
- May provide strategic and technical guidance on protocol implementation to sponsors
- Determines the overall direction, strategy and performance standards for the function.
- Develops collaborative alliances and relationships with clients, investigators, and advisors.
- Act as a thought leader within the organization and externally
- Lead, coach and mentor the business insights function
- Provides guidance and oversight to direct report(s) including the management of workload, special projects, performance management, salary review, and career development.
- Work with the proposal team to come up with the technical narrative for project feasibility and implementation
- May provide Clinical Operations expertise and leadership to cross functional project teams for assigned products and indications.
- May lead or co-lead complex strategic projects that are often cross-functional in nature
- Accountable for the development of study feasibility and study strategy infrastructure (which may include SOPs, WIs, Clinical Trial Management System, budget and planning).
- Proactively projects resource needs to ensure appropriate staffing to meet functional objectives.
- May oversee/participate in the implementation of sponsor and investigator meetings, conferences and workshops.
- Provides key leadership and expertise in client presentations and bid defense meetings.
- Supports efforts for generating business leads (client networking, public speaking, etc.).
- Provides leadership to proposals for project bids to incorporate therapeutic area expertise and to ensure that projects can be successfully implemented.
- Engages in strategic planning activities and implements strategic decisions.
- Provides strategic leadership to the planning and selecting sites and subject recruitment strategies.
- Through feedback from the client, recognizes systemic issues at the portfolio level and identifies solutions in collaboration with other functions.
- May act as the escalation point for some client or implementation-related issues within the portfolio; determines and executes resolution.
- All other duties as assigned.
Knowledge, skills and abilities:
- Proven ability to lead an international cross functional clinical research team.
- Deep knowledge of clinical trial management techniques and tools.
- Extensive knowledge of global clinical trials management environment.
- Proven experience in trial management, risk mitigation and change management.
- Extensive knowledge of international clinical research regulatory guidance documents and regulations.
- Able to plan and organize efficiently by developing processes and procedures and by maximizing the use of available internal and external resources.
- Good computer skills including knowledge and experience of Microsoft Office applications.
- High degree of accuracy and attention to detail.
- Well-developed oral and written communication skills.
- Education: Bachelors’ degree required, preferably in related field
- Preferred Job-related Experience: 8-10 years’ experience, increasing management responsibilities; Significant clinical operations experience a must, across phases and indications. Previous line management experience required.
- Preferences: Masters’ degree preferred; proficiency in other languages strongly preferred