Vice President - Clinical Research - Pharma

Qualification: - Advanced Post graduate degree

Reporting to : Executive Director, Head- Clinical Board.

- 12-15 years of experience in clinical research & administration

Key Responsibilities:

- The VP will oversee the Office of Clinical Research and be responsible for all clinical research policy development and oversight, ensuring that all research is conducted according to national & international regulatory standards (e.g. FDA Good Clinical Practice (GCP), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

- The VP will also oversee and be accountable for an operational infrastructure that underpins the clinical research activity of Research Division, including the Clinical Trials Office and related research administration functions (e.g.EC/IRB, contracting), and the other biomedical departments. Success will require close collaboration with the clinical departments and divisions, and other units that support the development and execution of clinical research studies with all funding sources.

Principal Duties And Responsibilities:

The VP is ultimately responsible for creating the infrastructure, processes, and analytics to assure that COMPANY is a leader in Ophthalmology research from the perspective of clinical investigators as well as sponsors and governmental grantors, and driving a strategic growth agenda to increase the number of high-impact studies conducted at COMPANY.

- Collaborate with the Chief Clinical Board and Chairman Research Development committee to establish the vision, strategic goals and priorities for the l clinical research at COMPANY on an annual basis

- Partner with clinical department chairs, division chiefs, and center/institute directors to pursue a growing, diverse portfolio of high-impact studies and trials

- Oversee a high-performance, customer-oriented centralized infrastructure that supports investigators to conduct, design and execute clinical research studies

- Develop and maintain performance expectations and metrics and drive continuous improvement in processes and infrastructure that underpin clinical research at COMPANY.

- Develop and manage relationships with external partners such as industry sponsors, government agencies, foundations, and other academic institutions to drive meaningful collaborations

- Partner with community leaders to ensure community trust and to drive community-engaged research and ensure recruitment of patients in the clinical studies

- Engage stakeholders across COMPANY including physicians, nurses, researchers, and others as the leader of clinical research for the institution

- Leads business development of national clinical trials network.

- Develops and maintains a strategic plan aligned with institutional goals and priorities for growth of a national clinic trials network; and drive forward long range goals for all network research strategies

- Represents the institution with external groups and organizations, with a high degree of professionalism, competence and discretion.

- Monitors clinical research quality

- Ensures appropriate research compliance controls are in-place.

- Builds on infrastructure to continuously improve the reporting, productivity, and overall management of research operations;

- Financial responsibility: You will be handling a research revenue portfolio of > 10 Cr or more on an annual basis

- People Management: You will be responsible for the management of the research team in various hospitals.

Education/Experience Required:

- Advanced Post graduate degree

- History of successful spearheading of clinical research department, and collaboration with, diverse sponsors/ clients, including both national and international

- Sound knowledge of Clinical research essential documents like protocol and study developments, CRF, ICF design etc

- At least 10 years' of experience in translational, site management and translational research administration within a large clinical department, research institute, or Academic Medical Center with direct oversight of clinical trial operations responsibility. Strong track record of achievement as an investigator in clinical trials and translational research

- Skill in building and maintaining collaborative relationships with physician investigators and research scientists

- Demonstrated accomplishments in clinical or translational research

- Excellent leadership skills and ability to drive results

- Robust networking skills with experts in academia & industry: solid record of maintaining and developing successful relationships with opinion leaders and investigators in diverse disciplines

- Strengths in research administration and management

- Ability to build consensus and use rationale over edict

- Blend of business acumen and altruistic sensitivities

- Proven ability to effectively lead change management in a complex research environment with an emphasis on outcomes, quality and cost containment.

- Excellent Project management skills, disciplines, team player, positive attitude,

- Excellent computer skills, MS Office, Excel, Word, PowerPoint.