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Medical Strategy Manager/Senior Medical Strategy Manager

3 months ago

Durham, North Carolina, United States United Therapeutics Full time

California, US residents click here ) .

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

Manage and oversee day-to-day operational and scientific activities within medical affairs and ensure assigned Investigator Sponsored Studies (ISS) and data query programs are managed appropriately. Represent medical affairs interests and needs in multi-disciplinary teams (e.g. project teams, clinical study team meetings). Conduct and oversee small strategic studies by medical affairs.

  • Responsible for identification of strategic gaps, strategic development, and interpretation of outcomes; responsible for authorship of Phase IIIb/IV study protocols, provide scientific support and oversight, primary scientific lead for data interpretation and analysis
  • Develop and deliver communications and presentations on clinical trial data and post-hoc data analyses; responsible for designing data analyses of clinical data sets; author manuscripts, abstracts, posters and presentations for scientific conferences and journals
  • Partial oversight of ISS program for proposals affecting assigned brands; in partnership with other Medical Affairs staff, understand strategic gaps and provide scientific and operational support to enhance the ISS review, approval, documentation, and tracking processes
  • Communicate with health care providers regarding data from recently conducted or ongoing studies; assess research interests
  • Provide operational oversight and manage external vendors/CRO for small strategic studies and non-interventional, minimal risk studies conducted by Medical Affairs; provide input for clinical operations/product development operations, as needed
  • Generate scientific materials and serve as scientific representation at advisory boards with health care providers
  • Stay abreast of developments and gather information and insight on Medical Affairs activities to leverage critical data and synthesize information for key stakeholders
  • Perform back up medical technical reviews of promotional materials, sales training materials, and other material for external use (e.g. advisory board content and non-promotional reprints) by providing medical/scientific input, validation of data, and consistency and compliance with product package inserts, established guidelines, institutional laws, regulations and practices
  • Participate and lead clinical discussions with health care providers; demonstrate a sound awareness and understanding of regulations and industry sensitivities that govern interactions with healthcare providers and third-party organizations
  • Perform other duties as assigned

For this role you will need

Minimum Requirements

  • Medical Strategy Manager : Doctor of Philosophy (PhD), Doctor of Pharmacy (PharmD) or MD with 2+ years of pharmaceutical/biotech company experience in Medical Affairs or a post-doc fellowship in Medical Affairs (Alternative pharma, healthcare, or other research experience may be taken into consideration)
  • Senior Medical Strategy Manager : Doctor of Philosophy (PhD), Doctor of Pharmacy (PharmD) or MD with 5+ years of pharmaceutical/biotech company experience in Medical Affairs or a post-doc fellowship in Medical Affairs (Alternative pharma, healthcare, or other research experience may be taken into consideration)
  • Possess working knowledge of therapeutic areas, internal and external treatment landscape, clinical studies and data, healthcare system dynamics relevant to Unither products and assets in development
  • Possess working knowledge of drug development for at least one therapeutic area and/or product
  • Record of accomplishment and increasing responsibility in scientific, clinical and/or pharmaceutical industry setting
  • Excellent written and oral communication skills
  • Ability to initiate and lead projects
  • Solid working knowledge of word processing, spreadsheet, email and presentation software (MS Office suite)
  • Ability to travel up to 25%

Preferred Qualifications

  • 4+ years of applicable experience in Medical Affairs

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.

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

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.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.