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| Job Title: |
Executive Director, Pharmacoepidemiology/Risk Mgmt |
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Job Location:
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Raleigh - North Carolina - USA |
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Job Category:
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Corporate and Executive Management
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Job description:
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Part of the Late Phase department’s senior management team with responsibilities that include: providing epidemiologic support for the design and conduct of observational research programs, late phase safety trials and post-approval safety surveillance studies; providing consulting support for the design and development of Customer risk evaluation and mitigation strategies (REMS) and risk minimization action plans (RiskMAPs); serving as the senior epidemiologic liaison to INCR Customers and to internal functional groups regarding data management, biostatistics and medical writing deliverables for late phase projects; managing assigned administrative operations of the Pharmacoepidemiology and Risk Management (PRM) group and supporting the Business Development group through participation in capabilities and proposal defense meetings. Assists the department head with the development of strategic and implementation plans for the department.
ESSENTIAL JOB FUNCTIONS:
1. Senior-level responsibility for delivery of epidemiologic services related to the design and conduct of observational research programs (e.g., patient registries, health outcomes studies), late phase safety trials (i.e., Phase III and IIIb) and post-approval safety surveillance studies. Services include study design, protocol development, data collection tool design, implementation planning, statistical analysis plan development, safety data analysis, study report writing and regulated safety report development.
2. Senior-level responsibility for delivery of risk management services associated with Customer REMS and RiskMAPs. Services include conduct of drug/device risk/benefit assessments, development of RiskMAPs, leading development of methodology for implementation of risk management program components, supporting development of Customer Periodic Safety Update Reports (in conjunction with INCR Pharmacovigilance group) and signal detection analyses.
3. Directs or conducts epidemiologic research in large longitudinal databases on behalf of Customers. Responsible for study design and methodology as well as directing development of analysis plan.
4. Serves as a line manager to all resources within the PRM group and/or other staff, as assigned. Approves courses of action on all management / human resources matters, including salary administration, transfers, hiring, terminations, professional development, performance appraisals, position description preparation and employee counseling for employees within their reporting structure. Works with and advises subordinates on administrative policies and procedures, technical problems, priorities and methods.
5. Provides senior-level direction to all PRM staff to ensure that all department projects are managed and delivered in accordance with contractual agreements, agreed to SOPs and in compliance with all pertinent industry/ regulatory guidelines and legal requirements.
6. Assigns project work and reviews workload for all direct reports. Manages staff development by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
7. Provides senior-level oversight/monitoring for all PRM group deliverables for assigned projects in terms of implementation quality, timelines, resource management, financial performance and internal/external customer communication. Works closely with clinical project managers to ensure PRM group remains in sync with other functional areas throughout the conduct of assigned studies.
8. Leads the development of responses to the epidemiologic and risk management components of Requests for Proposals (RFPs) and Requests for Information (RFIs) received by INCR.
9. Serves as a senior-level scientific liaison to all functional service groups within INCR (e.g., data management, biostatistics, pharmacovigilance, medical writing) to ensure Late Phase project deliverables incorporate appropriate epidemiologic perspectives.
10. Serves as a scientific mentor to Late Phase staff to help ensure an appropriate level of understanding regarding sound epidemiologic and risk management principles such that project teams consistently operate in compliance with such principles.
11. Maintains expertise in current regulatory requirements and industry practices related to the conduct of observational research, safety surveillance and risk minimization/management in the US, Canada, Europe and other key markets, as identified.
12. Works with the department head and other senior management staff to develop and implement department policies, operating procedures, working instructions and training materials. Also, ensures that training on all required policies, procedures and instructions is provided to all PRM staff and that completion of such training is documented in each employee’s official training record.
13. Represents INCR at pharmacoepidemiology, risk management and late phase research related industry meetings through attendance, participation in booth exhibits, speaking engagements, etc. Represents INCR by publishing scientific or industry related articles in industry journals.
14. Supports the department’s business development efforts through participation in Late Phase capabilities presentations, proposal defense meetings and other Customer meetings, as requested.
OTHER RESPONSIBILITIES:
1. Performs other work-related duties as assigned.
2. Moderate travel may be required (up to 50%). |
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Skills:
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Requires an advanced degree (i.e., MD, PhD or DrPH) in epidemiology, plus a minimum of six years experience designing and implementing epidemiologic studies at either a contract research organization (CRO) or a pharmaceutical or biotechnology company; prospective study and retrospective database study experience is preferred. A minimum of two years management experience within either a CRO or a pharmaceutical or biotechnology company is required; other relevant health outcomes experience is advantageous. Thorough knowledge of FDA and EMEA regulations regarding pharmacovigilance, risk management and safety reporting; drug development; epidemiologic research methodologies; and epidemiologic statistical analysis models are all required. A demonstrated creative and strategic perspective to problem solving is required. 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 are essential. Requires outstanding written and oral communication skills, dynamic presentation skills, good interpersonal skills and a team-oriented management style. General computer skills (e.g., email, Internet browsing) and proficiency in the Microsoft® Office applications (Word, Excel, PowerPoint) are required. Specialized computer skills in SAS, SPSS and/or STATA along with demonstrated expertise in statistical analysis is also required. Must have valid, current driver’s license and ability to secure corporate credit card. |
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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Masters |
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Experience (year):
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6 |
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Post Date:
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09/07/2008 |
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| Contact Information |
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Address:
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<a href="http://trials.in.ua">clinical research</a> 01033 - Ukraine |
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