Medical Director

Location
Prague
Salary
Competitive
Posted
May 23, 2022
Closes
Jun 22, 2022
Ref
3389
Function
Executive, Director
Industry
Science
Hours
Full Time
Medical Director

EU Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Medical Director, EU leads and directs clinical safety and pharmacovigilance, medical monitoring, medical consulting, clinical development and related activities for EU-based projects in conjunction with other project leadership. The Medical Director, EU assists the TRU Project Manager or Project Leader with proposal activities, protocol development activities and practical aspects of study conduct related to clinical trial safety monitoring as needed. The Medical Director, EU reports to the Chief Medical Officer and will contribute to business development activities, the clinical strategy for the CSP Group, and will assist with PV activities in collaboration with other members of the CSP Group.

Responsibilities
  • Leadership Activities:
    • Work directly with the Sr. Medical Director, Head of North American and India CSP, & CMO in overseeing both corporate and project related activities
    • Coordinates and manages hiring and labor utilization of Medical Monitors and Pharmacovigilance Officers for EU-based project activities.
    • Work with the project PM or TRU PL to provide strategic clinical development expertise and input for projects in order to achieve both project and corporate objectives
    • Provide leadership to the project teams and consult with sponsors, investigators, Safety Committees and pharmaceutical partners as required
    • Participate in corporate process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, SOP development, participation in internal and external audits, and professional development activities.
    • Other corporate activities, including annual SOP reviews, leading CSP Objectives and Key Results (OKRs), development and teaching EmmesU classes, participation in corporate safety meetings/activities; and other corporate CSP activities.
    • Other duties as assigned
  • Project Activities:
    • Ensure alignment of strategy, staffing and execution of projects by working closely with project leadership
    • Provide clinical safety and pharmacovigilance and medical affairs services for Emmes' comprehensive CRO support services including:
      • Participation as needed in protocol and key document development meetings
      • Answer questions about protocol objectives and procedures
      • Review SOC Charter, safety reports and meeting minutes
      • Participation in Sponsor meetings and investigator training meetings
      • Participation in regulatory (FDA or other) meetings and scientific review meetings
      • Interact with Pharmaceutical companies and other study partners
      • Participation in DSMB meetings as required
    • Provide key clinical input into proposals, client meetings and bid defense presentations
    • Provide high level medical input on safety considerations during development of protocol and associated documents to include:
      • Guide teams on best practices for PV in the therapeutic area
      • Advise study sponsor and team on protocol development, inclusion/exclusion criteria and eligibility questions, protocol study design and halting rules
      • Ensure the medical and scientific quality of documents such as clinical trial protocols, investigator's brochure, informed consent form, patient diaries, and case report forms
      • Work directly with the Medical and Safety Monitors to develop appropriate pharmacovigilance and other key documents and project plans (e.g. Safety Monitoring Plan, Medical Monitoring Plan, Communication Plan and Training Plan)
    • Provide direct project support as needed (~30%)
    • Provide medical input on safety considerations during development of protocol and associated documents
    • Other duties as assigned


Experience
  • Medical Doctor degree (MD, MBBS, MBBCh, or other equivalent) with ability to practice in the UK or EU member state is required for the position
  • 10 years' total experience consisting of the following:
    • Minimum 5 years' experience obtained in a clinical medical setting with demonstrated clinical medical expertise through practice experience
    • Minimum 5 years of pharmaceutical/biopharma industry experience
  • Regulatory experience (document drafting and/or review)
  • Familiarity with medical monitoring and serious adverse event reporting
  • Demonstrated working knowledge through experience or training in GCPs
  • Familiarity with or training in clinical trial data collection and medical monitoring
  • Capacity to work as a team member, ability to direct activities and encourage positive team-based culture
  • Capacity to provide leadership and creativity to the work environment
  • Excellent verbal and written communication skills


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.