Medical Officer (Neurology or Ophthalmology)

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We stive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Medical Officer (Neurology or Ophthalmology) provides medical expertise to internal and external teams and supports company strategy in given therapeutic area. The Medical Officer has functional responsibility for medical monitoring of clinical trials, medical review activities and for broad spectrum of internal and external medical consulting, including, but not limited to protocol development study feasibility, medical training and engagement with external clinical experts and key opinion leaders. The Medical Officer supports new business opportunities, presents at bid defense meetings.

• Works directly with the Global Head of Pharmacovigilance and Medical Monitoring, in managing both corporate and project-related activities. Cooperates directly with Safety Monitors, Project Managers, Data Managers and other relevant Emmes roles.
• Provides medical expertise and clinical insight to the specified therapeutic area (neurology or ophthalmology) to internal and external stakeholders. This includes patient population description, treatment standards and patient pathways.
• Provides medical support to other therapeutic areas as needed based, on their experience.
• Function in the role of a clinical trial Medical Monitor, leading the clinical trial monitoring of safety and efficacy data for the assigned protocols within the scope of the contract with the client and in compliance with relevant Standard Operating Procedures (SOP).
• Provides safety oversight throughout the lifecycle of the clinical study including evaluation, assessment, and monitoring of safety events and protocol deviations.
• Evaluates adverse events and serious adverse events (SAEs) including expedited reporting. Reviews SAE narratives and other safety reports.
• Works directly with project-level staff to develop appropriate study documents and project plans (e.g., Safety Monitoring Plan, Medical Monitoring Plan, Communication Plan, and Training Plan) and to review other study documents such as clinical trial protocols, investigator's brochure, informed consent document, patient diaries, and case report forms.
• Prepares medical strategy for the feasibility activities and proposal of country mix.
• Ensures relevant medical training for the assigned project staff.
• Engages with safety oversight committees (DSMB/DMC/SMC)
• Manages key opinion leaders and external consultants for the relevant therapeutic area.

• Medical Doctor degree is required.
• Board certification in the respective therapeutic area or equivalent or a minimum of 5 years of clinical practice in the therapeutic area are strongly desired.
• The Neurology Therapeutic Area Medical Officer should have experience in neurodegenerative disorders (Alzheimer's, Parkinson's, Huntington's disease and/or ALS). Experience in biological and gene therapies is a plus.
• The Ophthalmology Therapeutic Area Medical Officer should have a broad ophthalmology experience. Experience in retinal and macular disorders and experience in biological and gene therapies is a plus.
• Experience in clinical trials and other areas of pharmaceutical medicine (i.e. medical affairs, regulatory, pharmacovigilance, etc.) is beneficial.
• Fluent and be able to present in English.

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:

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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.