Medical Director (Oncology - Hematology) 2018-48270
This position can be home or office based in any of our US offices
As a Medical Director with PRA Health Sciences 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.
“Making a difference in the lives of patients.” “Exposure to cutting edge science.” “A shared commitment to work/life balance.” This is what motivates members of our Medical Director team.
- 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.
- 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.
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.
- 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.
- Reviews and interprets study results and clinical study reports.
Supports Business Development (BD):
- Builds relationships with new customers, maintains client relationships to obtain repeat business.
- 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.
- 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.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Apply Directly to Michelle Canada at: