Medical Director Neurology / Rare Diseases

Overview

Medical Director Neurology / Rare Diseases

US 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.

Purpose

The Medical Director leads and directs pharmacovigilance (PV) and medical consulting operations and activities and is responsible for ensuring adequate and appropriate staffing for proposals and projects as required, and leads proposal activities, protocol development activities, and practical aspects related to clinical trial safety monitoring. The Medical Director reports to the Chief Medical Officer (CMO) and will contribute to business development activities, the clinical strategy for the company, and PV activities in collaboration with other members of the Safety Services group.

Responsibilities

• Works directly with the CMO in overseeing both corporate and project-related activities.
• Directs and manages the Medical Officers and Safety Monitors to implement PV activities and achieve both project and corporate objectives.
• Provides oversight and leadership to the Medical Officers regarding interactions with safety oversight committees (SOC (may include Protocol Safety Review Team, Safety Review Committee, or Data Safety Monitoring Committee of Board)), and consults with sponsors, investigators, and pharmaceutical partners as required.
• Leads PV corporate process improvements and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, SOP development, participation in internal and external audits, and professional development activities.
• Participates in other corporate activities, including annual SOP reviews, leading PV Objectives and Key Results (OKRs), development and teaching of EmmesU classes, participation in corporate safety meetings/activities, and other corporate PV activities.
• Ensures alignment of strategy, staffing, and execution of projects by working closely with project leadership
• Leads PV services as well as Emmes' comprehensive CRO support services including:
• Participation as needed in safety oversight committee meetings
• Answering questions about safety monitoring and related procedures
• Reviewing SOC Charter, safety reports, and meeting minutes
• Participating in Sponsor meetings and investigator training meetings▪
• Participating in regulatory (FDA or other) meetings and scientific review meetings
• Interacting with pharmaceutical companies and other study partners
• Participating in DSMB meetings as required
• Provides key clinical input into proposals, c lient meetings, and bid defense presentations (<25%)
• Provides high -level medical input on safety considerations during development of protocol and associated documents, to include:
• Guiding Medical Officers and Safety Monitors on best practices for PV in a wide range of clinical trials
• Advising study sponsor and team on protocol development, inclusion/exclusion criteria, and eligibility questions, protocol study design, and halting rules
• Ensuring the medical and scientific quality of documents such as clinic al trial protocols, investigator's brochure, informed consent form, patient diaries, and case report forms
• Works directly with the Medical and Safety Monitors to develop appropriate pharmacovigilance documents and project plans (Safety Monitoring Plan, Medical Monitoring Plan, Communication Plan, and Training Plan)
• Provides medical monitoring direct support as needed (~50%)
• Provides safety oversight and throughout the lifecycle of the clinical study including evaluation, assessment, and monitoring of safety events and protocol deviations.
• Provides medical input on safety considerations during development of protocol and associated documents.
• Other duties as assigned.

Qualifications

• Medical Doctor degree (MD, MBBS, MBBCh, or other equivalent) with ability to practice in the US is required for this position.
• 15 years' total experience, consisting of the following:
  • 5+ years obtained in a Clinical Medical Setting with demonstrated clinical medical expertise through practical experience.
  • 5+ yeas Pharmacovigilance experience
  • 5-6 years Neurology and/or Rare Diseases
  • 5 years medical monitoring and serious adverse event reporting
• Demonstrated working kno wledge through experience or training in GCPs
• Demonstrated experience with or training in clinical trial data collection and medical monitoring
• Experience working with regulatory submissions
• Capacity to work as a team member and ability to direct activitie s and encourage a positive, team-based culture
• Capacity to provide leadership and creativity to the work environment
• Excellent verbal and written communication skills

Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Unlimited Approved Leave

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

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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.