United Therapeutics - Director - Medical Development - Silver Spring, Maryland
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. We have successfully gained FDA approval for five medicines and are always conducting new clinical trials.
How you’ll contribute
The Director, Medical Development works with a cross-functional team to ensure the medical/clinical integrity and quality of all studies conducted by Unither Bioengineering. This role serves as the primary or backup medical monitor contact in study protocols to investigators and study sites regarding protocol compliance issues and safety of the subjects enrolled. This position is located in our Silver Spring, MD office and will require the individual to be onsite 4 days per week, with the option to work from home 1 day per week.
- Serve as the primary medical contact for investigators and study site teams, addressing protocol compliance issues and ensuring the safety of enrolled subjects.
- Review and approve protocols, investigator brochures, and clinical trial reports in accordance with SOPs and good medical practices.
- Provide medical support and expertise for the execution of all commercial, clinical, and research use of ex vivo organ perfusion services.
- Conduct medical monitoring activities for allocated clinical studies, including the review and approval of study protocols, study design, and scheduled assessments.
- Provide clinical training for internal and external study team members and site personnel as required.
- Support the Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB) as needed.
- Maintain knowledge of relevant medical literature and attend important conferences, integrating relevant medical information into clinical development practices as needed.
- Perform all other duties as assigned.
For this role you will need
- MD with active medical license.
- 5+ combined years of medical monitoring clinical research experience in pharma/biotech/CRO industry and medical or surgical management of organ transplant recipients.
- Existing licensure in Maryland or Florida, or ability to obtain a license in those states.
- Ability to make medical decisions for the study independently and act as primary medical monitor on studies.
- High level of interpersonal and presentational skills.
- Clinical experience with solid organ transplantation (medical management or surgical).
Preferred Qualifications
- Experience in the relevant therapeutic areas.
The salary for this position ranges from $215,000 to $300,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities.
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