United Therapeutics
Associate Scientific Director, Medical Strategy
United Therapeutics, Wilmington, North Carolina, United States, 28412
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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. Develop and oversee strategic initiatives within the post-marketing space to address identified scientific gaps across product franchise. Ensure assigned Investigator Sponsored Studies (ISS) and data query programs are managed appropriately. Represent global medical affairs (GMA) interests and needs in multi-disciplinary teams (e.g. commercial and development project teams, clinical study team meetings). Conduct and oversee small strategic studies and Phase IV tactics led by GMA.
Lead Medical Affairs strategic planning, driving, tracking, and coordinating data generation in a timely and compliant manner across UT franchise; cover multiple disease states (e.g. PAH, PH-ILD, oncology) Develop strong relationships with thought leaders and elicit involvement and feedback on key medical strategies Communicate with investigators in the ISS program and foster timely execution of newly approved and ongoing studies; lead quarterly data reviews of new data generated from ISS program Design, execute, and manage strategic studies by medical affairs 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 Design and implement tactics for phase IV data generation Lead and/or participate in cross-functional teams to support products throughout their lifecycle (launch planning, medicine development plans, project team meetings, etc.) Identify data gaps across UT franchise; generate and present material for Medical Affairs field teams and Advisory Boards Stay abreast of developments and gather information, and effectively communicate 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 Collaborate with external HCPs, KOLs, and CROs to author scientific publications that further UT's medical strategy All other duties as required For this role you will need
Minimum Requirements
Doctor of Philosophy (PhD), Doctor of Pharmacy (PharmD) or MD with 8+ years of pharmaceutical/biotech company experience in Medical Affairs or a post-doc fellowship in Medical Affairs; alternative pharmaceutical experience may be taken into consideration. Record of accomplishment and increasing responsibility in scientific, clinical and/or pharmaceutical industry setting Ability to initiate and lead projects Solid working knowledge of word processing, spreadsheet, email and presentation software (MS Office suite) Excellent written and oral communication skills Excellent team building skills Ability to travel up to 25% Preferred Qualifications
2+ years of oncology experience
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
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. Develop and oversee strategic initiatives within the post-marketing space to address identified scientific gaps across product franchise. Ensure assigned Investigator Sponsored Studies (ISS) and data query programs are managed appropriately. Represent global medical affairs (GMA) interests and needs in multi-disciplinary teams (e.g. commercial and development project teams, clinical study team meetings). Conduct and oversee small strategic studies and Phase IV tactics led by GMA.
Lead Medical Affairs strategic planning, driving, tracking, and coordinating data generation in a timely and compliant manner across UT franchise; cover multiple disease states (e.g. PAH, PH-ILD, oncology) Develop strong relationships with thought leaders and elicit involvement and feedback on key medical strategies Communicate with investigators in the ISS program and foster timely execution of newly approved and ongoing studies; lead quarterly data reviews of new data generated from ISS program Design, execute, and manage strategic studies by medical affairs 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 Design and implement tactics for phase IV data generation Lead and/or participate in cross-functional teams to support products throughout their lifecycle (launch planning, medicine development plans, project team meetings, etc.) Identify data gaps across UT franchise; generate and present material for Medical Affairs field teams and Advisory Boards Stay abreast of developments and gather information, and effectively communicate 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 Collaborate with external HCPs, KOLs, and CROs to author scientific publications that further UT's medical strategy All other duties as required For this role you will need
Minimum Requirements
Doctor of Philosophy (PhD), Doctor of Pharmacy (PharmD) or MD with 8+ years of pharmaceutical/biotech company experience in Medical Affairs or a post-doc fellowship in Medical Affairs; alternative pharmaceutical experience may be taken into consideration. Record of accomplishment and increasing responsibility in scientific, clinical and/or pharmaceutical industry setting Ability to initiate and lead projects Solid working knowledge of word processing, spreadsheet, email and presentation software (MS Office suite) Excellent written and oral communication skills Excellent team building skills Ability to travel up to 25% Preferred Qualifications
2+ years of oncology experience
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