medical affairs in blue bell

posted
job type
permanent
salary
US$ 225,000 per year
apply now

job details

posted
location
blue bell, pennsylvania
job category
Biotechnology & Pharmaceutical
job type
permanent
salary
US$ 225,000 per year
reference number
25325
apply now

job description

Job Title: Medical Director (Hem/Onc)

Position Description

  • 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.

Position Responsibilities

  • 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 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.

Position Requirements

  • Board Certified, preferred. Board certification in Medical Oncology, Hematology, or Pediatric Hematology-Oncology, strongly preferred.
  • Licensed physician, preferred.
  • M.D. or D.O.
  • 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.
  • Ability to travel 15-20%.
  • 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.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.