Director, Clinical Operations - Global Medical Affairs

United Therapeutics Corporation•RTP, NC, NC

About The Position

United Therapeutics (Nasdaq: UTHR) is a public benefit corporation dedicated to developing novel pharmaceutical therapies and technologies for rare, deadly diseases and to address the shortage of transplantable organs. Founded in 1996, the company has developed six FDA-approved therapies for conditions like pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma. Their near-term pipeline focuses on additional therapies for PAH and pulmonary fibrosis (PF). Recognizing the critical need for organ transplants, United Therapeutics is also working on creating manufactured organs to eliminate transplant waiting lists and cure end-stage organ diseases. The Director, Clinical Operations will be responsible for leading the planning, execution, and management of all clinical research trials and strategic clinical projects across multiple indications. This role involves overseeing operational planning through trial close-out, ensuring compliance with company processes, GCP/ICH, and regulatory requirements. A key aspect of this position is building and developing the Clinical Operations team, including its processes and fostering a positive mindset. The Director will also develop and execute strategies for the Medical Affairs department, establish strategic foundations for projects, provide strategic oversight for Medical Affairs programs, and manage resource allocation, timelines, and budgets. This role requires regular interaction with senior management, executives, partners, and vendors, as well as building strong collaborative relationships and fostering operational efficiency. The Director will escalate complex challenges, provide recommendations, and support resolution efforts, while understanding interdependencies between Medical Affairs and other functions. They will champion the team's success by developing and enhancing SOPs and processes, and lead budget planning, forecasting, and management for late-phase clinical trials. Direct management of the team includes goal setting, performance management, coaching, mentoring, change management, and career development.

Requirements

Bachelor’s Degree in life sciences or relevant scientific discipline
15+ years of experience in clinical trial management in a senior role including managing Phase 1-4 studies, CRO/vendor management, CRA management, and clinical site monitoring
7+ years of experience with managing clinical trial budgets
4+ years of people management experience
Experience with all trial components supporting clinical studies
Computer literate with experience in Microsoft software suite and other relevant packages
Knowledge of Good Clinical Practice, regulatory processes, and clinical development processes
Demonstrated & reproducible results in clinical operations
Demonstrated ability to resolve issues with minimal supervision, and to understand when to escalate
Embraces training, mentoring and professional development of staff
Ability to work effectively under pressure
Ability to influence without authority
Ability to resolve issues with minimal supervision, escalating as needed
Demonstrated negotiation and conflict resolution skills
Advanced experience with successful collaboration across functions in a matrix environment
Project Management experience
Experience with Microsoft Office product suite required
Ability to travel up to 20%

Nice To Haves

Master’s Degree in life sciences or relevant scientific discipline
Doctor of Philosophy (PhD) in life sciences or relevant scientific discipline
5+ years of experience in clinical trial management managing Phase 3b/4 studies
5+ years of technical and operational experience in planning/ executing/ reporting clinical trials

Responsibilities

Lead the planning, execution, and management of all activities pertaining to clinical research trials and strategic clinical projects across multiple indications from operational planning through trial close out in compliance with UT processes and GCP/ICH and regulatory requirements.
Builds and develops the people, the processes and the positive mindset making up the Clinical Operations team.
Develop and execute, through effective delegation, strategies for the Medical Affairs department, including project-specific and cross-functional initiatives.
Establish the strategic foundation for projects and programs and empower the Clinical Operations team to drive continued development and execution.
Provide strategic oversight for Medical Affairs programs and projects, ensuring effective resource allocation, timeline management, and alignment with corporate objectives and budgets.
Regularly interact with senior management, executives, partners, and vendors to support Medical Affairs goals and objectives.
Build and maintain strong working relationships that promote collaboration and operational efficiency.
Escalate complex challenges to senior leadership, provide recommendations, and support resolution efforts.
Understand the interdependencies between Medical Affairs and other functions, and develop effective solutions to address complex cross-functional issues.
Foster and strengthen collaborative relationships within and across departments to support strategic clinical development objectives.
Champion the team's success by developing, enhancing, and supporting effective departmental and cross-functional SOPs and processes.
Lead and oversee budget planning, forecasting, and management activities for late-phase clinical trials.
Direct and manage the team, including goal setting, performance management, coaching, mentoring, change management, and career development.