Medical Director - Medical Development

United Therapeutics • Silver Spring, MD, United States • $200k - $250k / year • 1m ago

California, US residents

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. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

How you’ll contribute

The Medical Director works with a cross-functional team to ensure the medical/clinical integrity and quality of all drug, biological product, and medical device studies by Unither Bioengineering are conducted per all applicable regulations and in compliance with internationally accepted Good Clinical Practices (GCP) and that commercial, clinical, and research activities conducted by Lung Bioengineering is consistent with industry best practices. This role serves as the primary or backup medical monitor contact in study protocols to investigators and study sites team regarding protocol compliance issues and safety of the subjects enrolled, and is a critical member of the Clinical Development team within Unither Bioengineering. This role also serves as primary Medical Director support for Lung Bioengineering. 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. Handle routine and urgent medical inquiries from internal and external study teams and sites.
Serve as a subject matter expert in the field of organ transplantation and assist in strategic and tactical decision-making for activities related to organ transplantation, organ perfusion, and organ manufacturing.
Conduct medical monitoring activities for allocated clinical studies, including the review and approval of study protocols, study design, and scheduled assessments. Review and approve all versions of informed consent form templates. Review serious adverse events (SAEs) and safety information, including adverse events and clinical laboratory data, during study conduct. Recommend appropriate remedial action to ensure the protection of subject safety.
Provide clinical training for internal and external study team members and site personnel as required. Ensure that all medical questions raised during study conduct are answered appropriately and in a timely manner.
Support the Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB) as needed. Participate in the review and interpretation of study data, and the overall review and approval of final study reports. Document all medical monitoring activities and communications related to allocated studies.
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

Minimum Requirements

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.
MD - Physician - State Licensure Existing licensure in Maryland or Florida, or ability to obtain a license in those states.
Previous experience performing a clinical research role within a clinical research study site, clinical research organization, or pharmaceutical company.
Ability to make medical decisions for the study independently and act as primary medical monitor on studies.
Ability to assess medical and clinical subject matter to provide assistance to business development.
Previous experience within a clinical environment.
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.

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.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities.

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities.

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