Associate VP, Regulatory & Clinical Affairs - Organ Manufacturing
United Therapeutics Corporation
Location: Manchester, New Hampshire
Type: Full Time
Internal Number: R02590
What We Do
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.
We currently have 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 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, pediatric cancers and other orphan diseases.
In 2021, we became 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.
How you’ll contribute The Associate Vice President (AVP) of Regulatory & Clinical Affairs is responsible for leading, developing, and implementing the regulatory and clinical strategy for FDA approval of 3D-printed transplantable solid organs, including lung, kidney, and liver.
Lead the development and execution of the regulatory and clinical strategy for FDA approval of manufactured organs
Lead regulatory compliance efforts for GLP pre-clinical, GMP manufacturing, quality management, and clinical studies
Lead and coordinate all FDA interactions
Provide oversight of clinical study execution in collaboration with Organ Product Development and all members of the clinical study team
Responsible for the design, implementation and reporting of clinical trials that meet the highest standards of excellence for ethics, scientific merit, and regulator’s compliance, as well as satisfy corporate goals for approval of the product
Routinely interface with R&D teams and manufacturing teams to ensure alignment towards meeting clinical strategy goals and timelines
Identify and implement appropriate development strategies for projects
Provide oversight of vendor selection for vendors that will support all aspects of the development program
Develop an integrated clinical strategy leading to FDA approval of 3D printed organs, while at the same time having the judgment to prioritize activities, improve processes and meet timelines
Build and lead a regulatory and clinical affairs team of 3-5 people
Conduct interviews, make hiring decisions, provide salary recommendations, monitor and assign work, coach, mentor and develop employees; develop work plans and conduct performance evaluations
Perform other duties as assigned
*This position requires working in-person from our Manchester office five days per week, when not on business travel*
For this role you will need
Bachelor’s Degree in Arts/Sciences (BA/BS) in life science
10+ years of experience in the pharmaceutical industry or cell therapy industry, or a combination of relevant education and experience
4+ years of management experience
Thorough understanding of the drug / biologics development process from pre-IND through registration and post-registration
Proficiency with Microsoft Office, in particular Word, Excel and PowerPoint
Critical traits for success include strategic and proactive thinking, decisiveness and the ability to perform as a respected team member and leader
Experience leading and managing a team
Direct experience developing and implementing regulatory strategy for IND/CTA-MAA programs
Experience managing clinical development programs from nonclinical through Phase 3
Experience working with external CROs and CDMOs
Familiarity with tissue engineering and regenerative medicine field
Familiarity with combination and biological products
Familiarity with cell therapy products
Familiarity with biomaterials used in therapeutic products
International clinical trial experience
Experience managing external partnerships
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
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.