JOB DESCRIPTION
Deputy Director, Clinical Trials - Institute of One World Health (New Delhi)
1. POSITION VACANT: Deputy Director, Clinical Trials (DDCT)
2. ORGANIZATION BACKGROUND:
The Institute for One World Health (iOWH) is a non-profit, drug development organization with a mission to develop a portfolio of innovative solutions, both preventive and therapeutic, for some of the world’s most neglected diseases which disproportionately afflict the very poor and marginalized peoples of the world. The success of this endeavor has the potential to positively impact millions of lives.
iOWH works in the most impoverished villages, states and countries in the world, including Sub-Saharan Africa, India, Nepal, Bangladesh and Vietnam.
For more information about iOWH, please visit, http://www.oneworldhealth.org/
3. JOB DESCRIPTION/ RESPONSIBILITIES:
Reporting to the Medical Director, the Deputy Director of Clinical Trials (DDCT), shall be responsible for defining the clinical trial strategy and management of all clinical studies being conducted by iOWH. S/he will be responsible for implementing, monitoring, and ensuring the success of clinical operations plans. The DDCT must ensure that clinical trial activities adhere to ICH, GCP, GMP, and regulatory guidelines. S/he will coordinate the efforts of internal and external resources to ensure timely patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality.
Key Responsibilities:
1. Project Management:
(1) Directly managing Clinical Operations Staff: Monitoring Services, Client Services and Project Managers
(2) Networking with other Heads of Organization Local and Global
(3) Developing the Country Clinical operations group
(4) Managing the conduct of Organization sponsored Phase I-IV clinical research programs, with appropriate use of internal or external resources
(5) Drives ongoing improvements in key performance metrics and quality management
(6) Handling oversight responsibility for agreed aspects of trials that are outsourced (globally or locally)
(6) Providing periodic reporting on clinical research activity and key metrics to Area management
(7) Supporting the preparation, filing, and prosecution of CTA’s to initiate clinical trials, where appropriate
(8) Supporting the development, adoption, and implementation of processes and systems necessary for the effective conduct of clinical research
(9) Monitoring and communicating any current and potential changes in local regulations related to the conduct of clinical research and to the local pharmaceutical industry in general, being a source of expert knowledge regarding the designated country in terms of regulatory, legal, ethical, and clinical practice considerations
(10) Maintaining and communicating knowledge on country capability, capacity, and clinical research environment to Clinical Study Operations and local Medical Affairs
(11) Ensuring effective organization and deployment of clinical operations resources including the planning and prioritization of future resource requirements
(12) Forecasting and properly executing clinical operations budget to minimize costs
(13) Responsible for ensuring the performance management of all clinical operations staff including goal setting, performance reviews, career guidance, and developmental opportunities
(14) Actively creates an environment of openness, innovation, and inclusiveness that promotes effective change and a philosophy of Continuous Improvement
(15) Maintaining effective relationships with other platform lines, Business Units, and enabling lines that would facilitate more effective portfolio delivery.
2. Budgeting:
(1) Handling the responsibility of Clinical Operations budgets.
3. Contract Management /Compliance/ Liaison/ External Relations:
(1) Vendor oversight: ensuring that they operate to the required standards and budgets
(2) Reviewing protocols, CRFs, and scientific documents for appropriate feasibility evaluation and feedback to Clinical Study Operations & the Business Units. Responsibilities include timely responses to Program, Protocol and Site Level feasibility
(3) Partnering with and developing strong links with key sites within the country so that these can be used to support clinical trials
(4) Drives compliance by partnering with quality and compliance groups
(5) Partnering with Development Operations colleagues and local Business Units in the selection and placement of clinical research studies
(6) Working intimately with business development on bid generation and bid defense.
4. Personnel Management:
(1) Managing the Clinical Operations group, staffing, ensuring that staff are appropriately qualified and trained for the roles they are undertaking.
5. Procurement:
(1) Responsibility for clinical supplies management.
4. QUALIFICATIONS, EXPERIENCE AND COMPETENCIES:
Qualifications:
(1) Applicants must be graduates in health, medicine, or related field
(2) Post graduation in Medical Microbiology is highly desirable
(3) Post graduation in Microbiology, Pathology, Biotechnology, and Pharmacy will be an advantage.
Experience:
(1) Minimum eight years of experience in managing Healthcare, Medical, or R&D Department of a Pharmacy/ Biotech/ Clinical Research Industry
(2) Demonstrated experience in resource forecasting and budget management
(3) Significant experience in operational aspects of clinical drug development (including managing people)
(4) Experience in vendor management.
Skills:
(1) Strong understanding and application of performance and productivity metrics
(2) Leadership, project management, resource management (staff and financial), coaching, change management, administrative, and technical capabilities
(3) Effective and fluent verbal and written communication skills in English
(4) Multi-cultural awareness
(5) Independent judgment and decision-making skills with respect to functional responsibilities.
5. COMPENSATION OFFERED:
The compensation for DDCT is attractive. Please note that the offer made to the selected candidate shall be commensurate with qualifications, experience and salary history.
6. LOCATION:
New Delhi
7. REFERENCE:
DDCT-iOWH
8. CONTACT INFORMATION:
Senior Consultant
Strategic Alliance Management Services P Ltd.
B 372 New Friends Colony
New Delhi 110 025
Email: ddct-iowh@sams.co.in
9. LAST DATE FOR APPLICATIONS:
Eligible candidates interested in this position are requested to apply with a cover letter, their updated resume and details of current and expected compensation to the above email id, by or before July 10, 2011. For further details please visit our website www.sams.co.in
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