The Emmes Company, LLC is searching for a Chief Medical Officer located in our Rockville, Maryland office. Emmes provides flexibility for office location preference, dependent upon position.

The Emmes Company, LLC is a private Contract Research Organization (CRO).  Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India.  Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research.   Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

The Chief Medical Officer (CMO) position has functional responsibility for pharmacovigilance (PV), medical consulting and review activities including protocol development activities and practical aspects of clinical trial safety monitoring. Additionally, the CMO is critical to business development activities and will lead the expansion of PV activities across an array of commercial clients, while supporting efforts to increase Emmes’ visibility as a CRO of choice for Phase 2, 3 and 4 clinical trial support.  The position requires an understanding of Emmes’ core strengths and expertise and coordination with the Chief Business Officer in making connections to identify new clientele that would be a match for Emmes’ service offerings.  Familiarity and contacts in the commercial space as well as comfort presenting at scientific meetings is required.  Sharing and embracing our company values of CHARACTER achieves RESULTS is a must.

Responsibilities

• Directs and oversees a team of Medical Officers
• Provides oversight of corporate and project related activities for existing clients and new business in the government and commercial sector
• Engage in key business development initiatives including developing independent PV services in addition to technical medical inputs for proposals, client meetings and bid defense presentations
• Ensure alignment of strategy and execution of projects by working closely with project leadership
• Oversee safety oversight throughout the life cycle of the clinical study including evaluation, assessment and monitoring of safety events and protocol deviations
• Provide leadership for process improvement and quality approaches related to PV services as well as Emmes’ comprehensive CRO support services
• Provide oversight of processes and procedures for Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding including:
  • Ensuring quality and timeliness of evaluation of adverse events and serious adverse events (SAE) including expedited reporting, SAE narratives and other safety reports, IND/IDE safety reports (MedWatch safety reports (FDA Form 3500A), Council for International Organizations of Medical Sciences (CIOMS) safety reports, and Development Safety Update Reports (DSUR), as applicable.
  • Reviewing the FDA MedWatch Alerts and safety communications and recommend action for implementation by Emmes, as applicable
• Provide high level medical input on safety considerations during development of protocol and associated documents to include:
  • Guide Medical Officers on best practices for PV in a wide range of clinical trials
  • Advise Study sponsor and study 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 document, patient diaries, and case report forms
  • Work directly with the Medical Officers to develop appropriate pharmacovigilance documents and project plans (Safety Monitoring Plan, Communication Plan and Training Plan)
• Provide oversight and leadership to the Medical Officers regarding interactions with safety oversight committees (SOC), and consult with sponsors, investigators and pharmaceutical partners including:
  • Participate as needed in safety oversight committee meetings (DSMB/DMC/SMC); answering questions about safety monitoring and related procedures (e.g., review of halting rules)
  • Review SOC Charter, safety reports, and meeting minutes
  • Participate in Sponsor meetings, and investigator training meetings
  • Participate in regulatory (FDA or other) meetings and scientific review meetings
  • Interact with Pharmaceutical companies and other study partners
• 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 include annual SOP reviews, development and teaching EmmesU classes, participation in corporate safety meetings/activities; and other corporate PV activities
• Define consistent global standards for expansion of medical and scientific activities
• Assist in evaluation of acquisition opportunities
• Other duties as assigned

Experience

• Medical Doctor degree (MD, MBBS, MBBCh) with ability to practice in the US is required for the position
• Active US Medical License required
• 15 years’ total experience consisting of the following:
  • Minimum Five years’ experience obtained in a clinical medical setting with demonstrated clinical medicine expertise through practice experience
  • Specific therapeutic expertise in Emmes’ core offerings such as Vaccine & Infectious Diseases, Cancer, Child & Maternal Health, Substance Use Disorders, Neurology, Ophthalmic, Transplant, Allergy, and/or Autoimmune knowledge a plus
  • Five years of pharmacovigilance experience, preferably in a CRO and with strong ties to Industry
  • Minimum five years’ experience directly supervising and providing leadership to physicians and other medical staff
• Expertise in medical monitoring and serious adverse event reporting
• Demonstrated working knowledge through experience or training in GCPs
• Demonstrated experience with or training in clinical trial data collection and medical monitoring
• FDA or regulatory experience desired
• Ability to maintain a high degree of integrity and utilize strong interpersonal skills to carry out positive interactions with internal and external contacts
• Excellent verbal and written communication skills
• Ability to work and live in the US required
• Up to 25% United States based travel between sites and occasional International travel required

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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.