United Therapeutics Medical Director/Senior Medical Director - Medical Monitoring in Durham, North Carolina
The Job Details are as follows:
Works to ensure individual subject safety and the scientific integrity of studies during the clinical development of United Therapeutics Corporation (UTC) products in accordance with ICH Good Clinical Practice (GCP), applicable regulatory guidelines and company standard operating procedures (SOPs).
Key Accountabilities / Responsibilities
Provide medical expertise, advice, and guidance to members of the clinical development project teams as and when required.
Provide medical support for routine medical inquiries for internal and external study teams and sites.
Provide on-call medical support for urgent medical inquiries.
Participate in review and approval of study protocols, with focus on study design, scheduled assessments, and protection of subject safety.
Review and approve all versions of the patient information leaflet and informed consent form templates.
Participate in the draft, review and ownership of study-specific medical monitoring plans (MMP).
Review study statistical analysis plans.
Provide appropriate clinical training for internal and external study team members and site personnel when required before and during conduct of studies.
Provide medical advice and ensure that all medical questions raised during study conduct are answered appropriately and in a timely manner.
Review serious adverse events (SAEs) that occur during studies and assist Global Drug Safety in identifying any emergent safety concerns that may be related to study conduct.
Review safety information including adverse events and clinical laboratory data during study conduct.
Review the outputs of safety signal detection analysis and recommend appropriate remedial action as necessary to ensure the protection of subject safety.
Support the Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB) when such a Committee is constituted for a study.
Review draft data listings, including coded data provided by Data Management, to ensure its medical consistency.
Participate in the review and interpretation of study data.
Participate in the overall review and approval of final study reports.
Document all medical monitoring activities and communications related to allocated studies.
Perform other duties in support of clinical development programs as requested.
Medical Doctor (M.D.) degree, and full registration with a medical licensing body such as the General Medical Counsel (GMC) required.
3+ years’ experience in a Medical Monitor or clinical development oversight role within a clinical research organization or pharmaceutical company.
Experience applying scientific knowledge and insight to clinical development strategy and clinical study protocol.
Proficiency with MS Office suite.
Ability to travel up to 20% as needed.
Preferred Knowledge, Skills, and Abilities
US Board-certified M.D. strongly preferred.
Therapeutic background in pulmonology or cardiology strongly preferred.
Excellent interpersonal, communication, and presentation skills.
Experience mentoring departmental staff.
Experience collaborating with various departments and investigators.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
United Therapeutics currently has five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia.
We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high level job performance, and provide state of the art facilities in which to flourish. This is what makes United Therapeutics a stimulating place to work. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation, and achievement into success.