RPS Career Opportunities

Title: Medical Director, Infectious Disease
Reference Number: 46153-B
Location: Remote/US/Canada

Description:

Excellent opportunity for an Infectious Disease Medical Director to 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. The Medical Director may assist Business Development group in tasks related to marketing and selling CRO services. This position can be based anywhere in the United States or Canada.

Responsibilities include (but are not limited to):

  • Provides medical expertise on drug development and, benefit/risk evaluations 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, selection, and recruitment of investigational sites
  • Provides continuous medical monitoring during study conduct, answering site questions on inclusion/exclusion criteria or other protocol questions, evaluation of SAEs and AEs, review of laboratory and other patient’s data, review of codes for medical history, concomitant diseases and medications, adverse events, and provides medical expertise to project team during life-cycle of study
  • Assumes responsibility for ethical, e.g. medical, aspects of study
    • Leads and/or contributes to discussions with regulators and/or investigators, opinion leaders, internal and external clients, and project team support
    • 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
  • Provides drug safety expertise for drugs, diagnostics, and devices in development and during market authorization
  • Reviews Safety Management Plans, evaluates adverse events and assesses regulatory reporting requirements, generates and/or reviews notification letters to regulators, investigators, IRBs and Ethic Committees, reviews, analyses and summarizes data for Data Monitoring Committees, generates and/or reviews Annual Safety Reports, protocol deviations and correspondence to health authorities, investigators, clients, and/or third parties
  • 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, develops Safety Development Plans, Pharmacovigilance Plans, Risk Management Programs including design and conduct of safety studies
  • Establishes safety systems including SOPs, Safety Database, tracking system, metrics, and serves as qualified PV person, however, the ultimate legal responsibility lies with client
  • Supports generation of publications and expert reports
  • Reviews and interprets study results and 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
  • 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, designs and/or leads investigations, recommends interventions to clients, and contributes to hearings at regulatory agencies and/or court
  • Develops and provides training
  • Provides therapeutic training relevant to specific study to project team, attends and/or presents at Investigator, internal and external project team meetings
  • Develops and implements training for PMs, CRAs, CSAs, CDCs, STATS, AP, DP, medical monitoring associates, medical writers; serves as an active mentor to one or more junior staff members and provides formal in-service training as requested by the functional leader; serves as a mentor/expert for new employees
  • Supports Business Development by providing medical expertise to identify, acquire, and win new business
  • Builds relationships with new customers, maintains client relationships to obtain repeat business, identifies new business opportunities through contacts, literature, and conferences
  • Active involvement in scientific meeting, 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

Qualifications:

  • Licensed physician and US BC in Oncology & Hematology
  • Clinical practice and/or clinical research or drug safety experience preferred
  • Experience writing pharmaceutical or health-related documents required
  • Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal preferred
  • Knowledge of regulatory requirements preferred
  • Good communications skills required
  • Project leadership/ management skills preferred
  • Experience using computerized systems (PC-Windows and MS Office)
  • Read, write, and speak fluent English; fluent in host country language