Requisition Number 2016-34900
This position can be home or office based in any of our US offices
Do you want to watch clinical development change, or do you want to be the one to shape it? Because we’re hoping you’re here for the latter. The PRA Medical Affairs team is kind, brilliant and filled with the industry leading experts across different therapeutic areas. There is no better team out there and that’s coming from Medical Directors who have been with us from 6 months to 19 years.
The rumors are true—with 6.5 former employees returning every month, the grass IS greener at PRA. We are a team of 13,000 moving forward together with a common goal, and given the support, tools and technology needed, that single step has become a movement. Interested? Come join the movement and discover your passion, your purpose, your PRA.
As a Medical Director you will provide medical expertise for site identification, study feasibility, study design, conduct, analysis and reporting, generation of integrated databases, pooled analyses for efficacy and safety, IAE and IASs, dossiers for regulatory submissions for market authorizations of new medicinal products, and diagnostics and devices.
- Provides medical expertise on clinical drug development throughout life-cycle of compound:
- Supports study design, generation of study protocol, CRF, informed consent, Investigators Drug Brochure, Statistical Analysis Plan, and other study material.
- Provides continuous medical monitoring during study conduct, answers site questions on inclusion/exclusion criteria or other protocol questions, evaluates and assesses SAEs and AEs, reviews laboratory and other safety parameters, reviews patient profiles, reviews coded terms for medical history, concomitant medications, adverse events, and provides medical expertise to project teams during life-cycle of study.
- Provides therapeutic training relevant to specific study to the project team.
- Attends and/or presents at investigator, internal and external project team meetings.
- Defines criteria for, assesses and evaluates protocol deviations and recommends on actions to be taken.
- Assumes responsibility for ethical, e.g. medical, aspects of study.
- Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients.
- Supports the feasibility group in developing feasibility plan and questionnaire, in determining type of investigational sites and in selecting countries and sites. Reviews feasibility results and report.
- Assists the clinical team in selection and recruitment of investigational sites.
- Provides benefit/risk evaluations and drug safety expertise for drugs, diagnostics, and devices in development and during market authorization:
- Evaluates and assesses serious adverse events.
- Generates and/or reviews notification letters to health authorities, investigators, IRBs and Ethic Committees.
- Reviews, analyses and summarizes data for Data Monitoring Committees.
- Contributes to and reviews Aggregate Safety Reports, evaluates benefits and risks of a medical compound/diagnostic and/or device including epidemiology of specific indication, natural course of disease, standard of care, alternate treatment options.
- Contributes to and reviews Safety Management Plans, Signal Detection Plans, Pharmacovigilance Plans, Risk Management Plans including design and conduct of safety studies.
- Provides benefit/risk evaluations and drug safety expertise for marketed drugs, diagnostics, and devices:
- Evaluates spontaneous reports and literature cases.
- Provides individual and cumulative benefit/risk assessments.
- Communicates with reporting health care professionals, experts and consumers.
- Reviews and authorizes Periodic Safety Update Reports.
- Evaluates safety issues.
- Recommends interventions to client.
- Contributes to hearings at regulatory agencies and/or court.
- Supports generation of publications and expert reports:
- Reviews and interprets study results and clinical study reports.
- Generates expert reports and supports IAS/IAEs, NDAs/PLAs, and other regulatory submissions, as well as generates and/or reviews publications, posters, and scientific presentations.
- Supports Business Development (BD):
- Builds relationships with new customers, maintains client relationships to obtain repeat business.
- Identifies new business opportunities through contacts, literature, and conferences.
- Promotes PRA through active involvement in scientific meetings and speaking engagements.
- Contributes to RFPs by identifying critical success factors and providing options for different approaches for patient recruitment, referral systems, and operational execution.
- Attends bid defense meetings including generating presentations and, takes active role in RFP discussions with clients.
- Supports BD in client contacts to discuss portfolio and development strategies.
What do you need to have?
- Board Certified Preferred
- Licensed physician
- 3+ years of experience writing pharmaceutical or health-related documents.
- Significant clinical trial experience
- Excellent communications and presentation skills
- Experience using computerized systems (PC-Windows and MS Office).
- Read, write, and speak fluent English; fluent in host country language.
- Clinical practice and/or clinical research or drug safety experience.
- Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal.
Email Address for Application: LinksSam@prahs.com
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities